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Ethics approval and consent to participate | This research was reviewed and approved by the Kaiser Foundation Research Institute Institutional Review Board (IRB) FW00002344 of Kaiser Permanente Washington. All methods were carried out in accordance with relevant guidelines and regulations as assessed by the IRB. IRB-approved procedures were used to obtain informed consent from study participants. | PMC9874175 | ||
Consent for publication | Not applicable. | PMC9874175 | ||
Competing interests | The authors have no conflicts of interest relevant to this article to disclose. The authors have no financial relationships relevant to this article to disclose. | PMC9874175 | ||
References | PMC9874175 | |||
Subject terms | TRD, treatment-resistant depression, ideation | ADVERSE EVENTS, REMISSION, DRUG WITHDRAWAL | Psilocybin is being investigated as a treatment in adults with treatment-resistant depression (TRD). Withdrawal from serotonergic antidepressant drugs is a common prerequisite for taking part in trials of psilocybin due to the possibility of ongoing antidepressant drugs altering the psychedelic effect. This phase II, exploratory, international, fixed-dose, open-label study explored the safety, tolerability, and efficacy of a synthetic form of psilocybin (investigational drug COMP360) adjunct to a selective serotonin reuptake inhibitor in participants with TRD. Participants received a single 25 mg dose of psilocybin alongside psychological support and were followed-up for 3 weeks. The primary efficacy end point was change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from Baseline at Week 3. Secondary end points were safety, including treatment-emergent adverse events (TEAEs), the proportion of responders and remitters at Week 3, and the change from Baseline to Week 3 in Clinical Global Impression–Severity (CGI-S) score. Nineteen participants were dosed and the mean Baseline MADRS total score was 31.7 (SD = 5.77). Twelve (63.2%) participants had a TEAE, most of which were mild and resolved on the day of onset. There were no serious TEAEs or indication of increased suicidal ideation or behavior. At Week 3, mean change from Baseline in MADRS total score was −14.9 (95% CI, −20.7 to −9.2), and −1.3 (SD = 1.29) in the CGI-S. Both response and remission were evident in 8 (42.1%) participants. Larger, comparator-controlled trials are necessary to understand if this paradigm can optimize treatment-outcome where antidepressant drug withdrawal would be problematic. | PMC10425429 |
Introduction | TRD, treatment-resistant depression, depressive disorder, treatment-resistant, MDD, cancer-related depression | Psilocybin has demonstrated antidepressant properties in preclinical models and small trials of participants with cancer-related depression, major depressive disorder (MDD), and treatment-resistant depression (TRD) [Reports from surveys suggest that the acute subjective psychedelic effects of psilocybin, and of another serotonergic drug, lysergic acid diethylamide (LSD), are diminished by use of antidepressant drugs in the weeks or months prior [In contrast, a recent double-blind randomized controlled trial in healthy participants found that administration of an SSRI for two weeks did not significantly alter the acute subjective effects of 25 mg of psilocybin [This exploratory phase II clinical trial used an open-label, fixed-dose design to investigate the safety and efficacy of a synthetic form of psilocybin with psychological support, adjunct to an SSRI, in participants experiencing a treatment-resistant episode of MDD. | PMC10425429 | |
Materials and methods | PMC10425429 | |||
Trial oversight | treatment-resistant MDD | This was a phase II, exploratory, fixed-dose, open-label study conducted between August 2020 and September 2021. This trial explored the safety and efficacy of a single dose of 25 mg of the investigational drug COMP360, a proprietary pharmaceutical-grade synthetic psilocybin formulation, optimized for stability and purity, adjunct to an antidepressant drug in participants experiencing a current episode of treatment-resistant MDD (EudraCT number: 2018 002377; Clinicaltrials.gov identifier: NCT04739865). COMP360 was supplied by the sponsor, COMPASS Pathfinder Ltd (a subsidiary of COMPASS Pathways plc), London, UK. The protocol was approved by ethics committees at two sites located in Ireland and the United States (US): the Clinical Research Ethics Committee of the Cork Teaching Hospitals (CREC), and the Advarra Center for IRB Intelligence (CIRBI). Participants provided written informed consent prior to participation.The sponsor supervised the study which was conducted by a contract research organization (Worldwide Clinical Trials, Nottingham, UK, and North Carolina, US). The study was conducted in accordance with the International Conference on Harmonisation Good Clinical Practice guideline, and the ethical principles of the Declaration of Helsinki. | PMC10425429 | |
Participants | TRD, psychiatric | DISORDER, DISORDERS | This study recruited adults aged 18 years or older who were outpatients and referred by practitioners from specialized psychiatric services or word of mouth from primary care services. Participants were experiencing TRD, defined by meeting the Diagnostic and Statistical Manual of Mental Disorders (5Participants were taking a locally approved therapeutic dose of a single SSRI with at least 75% adherence for a minimum of six weeks prior to taking part and were asked to continue this treatment for the duration of the study. Permitted SSRIs included citalopram, escitalopram, fluoxetine, paroxetine, sertraline, vilazodone, and vortioxetine. Participants taking multiple antidepressant therapies were excluded.Participants experiencing a major comorbid psychiatric disorder or suicide risk were excluded based on clinical assessment, medical records, the Mini International Neuropsychiatric Interview (version 7.0.2), the McLean screening instrument for borderline personality disorder, and the Columbia-Suicide Severity Rating Scale (C-SSRS) [ | PMC10425429 |
Study design and procedures | C-SSRS | BLOOD | Eligible participants entered the screening period and attended the clinic weekly for three weeks prior to the psilocybin administration session. During this time, eligibility and safety assessments took place including monitoring of medication changes, suicidality (C-SSRS), electrocardiograms (ECGs), blood tests, and vital signs.Preparation for the psilocybin experience was conducted by a therapist who was trained by the sponsor through a specially devised program [The administration session (Day 1) consisted of a single administration of psilocybin 25 mg which could be administered to up to six participants in different rooms simultaneously. Each participant was accompanied by a lead therapist, with whom they had completed preparation, for the six- to eight-hour session to ensure physical and psychological safety and encourage the participant to remain attentive to the natural unfolding of their subjective experience, while avoiding active guidance. An assisting therapist was available within the vicinity to step in at any time if the lead therapist needed to leave or additional support was required, and a study psychiatrist was on site. Blood pressure was monitored continuously using a finger cuff device. If simultaneous administration took place, the lead therapist remained with the participant and one assisting therapist was available by moving between rooms. Participants wore eyeshades and headphones with a specifically designed playlist of music to assist in directing their attention internally. Participants returned home after the acute drug effects had passed.Participants were followed up for three weeks to monitor safety and efficacy. At Day 2 and Week 1 following administration, participants completed an integration session with their lead therapist who encouraged them to derive their own solutions and insights from the psilocybin experience. | PMC10425429 |
Safety end points | ideation | ADVERSE EVENTS, EVENTS | Safety outcomes included ECG, clinical laboratory tests, vital signs, incidence of adverse events, and change from Baseline in suicidal ideation and behavior measured by the C-SSRS.Adverse events were examined at every visit and followed until resolved or stable. Treatment-emergent adverse events (TEAEs) were coded using the Medical Dictionary for Regulatory Activities version 23.0. | PMC10425429 |
Efficacy end points | Depression, ill | SECONDARY, REMISSION | The primary efficacy end point was the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from Baseline (Day -1) to three weeks post-psilocybin administration (Week 3) [Key secondary end points included the proportion of participants with a response (defined as a ≥50% improvement in MADRS total score from Baseline) and remission (defined as a MADRS total score ≤10) at Week 3, change from Baseline in Clinical Global Impression–Severity (CGI-S) score at Week 3 and proportion of participants with a response (defined as a score on the CGI-S of 1 (“normal, not ill at all”) or 2 (“borderline mentally ill”)) [ | PMC10425429 |
Exploratory end points | depression, Depressive, Anxiety, anxiety | DISORDER | Exploratory end points included change in total score from Baseline to Week 3 in participant EQ-5D-3 level (EQ-5D-3L) which captures an index of health state based on response to five dimensions of quality of life on a three-point scale ranging from “no problems” to “extreme problems” and additionally includes the EQ-VAS ranging from “worst imaginable health state” (score = 0) to “best imaginable health state” (score =100), Generalized Anxiety Disorder 7-item (GAD-7) where total scores range from 0-21 with higher scores indicating greater severity of anxiety, self-reported Quick Inventory of Depressive Symptomatology 16-item (QIDS-SR-16) where total scores range from 0-27 and higher scores indicate greater severity of depression, the Clinical Global Impression-Improvement (CGI-I) which is a 7-point rating scale of improvement based on clinical judgment, with lower scores indicating greater improvement [The acute subjective psychedelic experience was captured by the Five-Dimensional Altered States of Consciousness questionnaire (5D-ASC) once the acute psychedelic effects had subsided (end of Day 1) [ | PMC10425429 |
Statistical analysis | suicidality | SECONDARY | No formal sample size calculations were performed for this study. There was no imputation for missing efficacy data and the observed data were used in statistical analyses.Safety analyses were performed on the safety analysis set which included all participants who received psilocybin. Descriptive statistics were used to analyze safety data including TEAEs, concomitant treatments, evaluations of vital signs, clinical laboratory tests, findings from 12-lead ECGs, and suicidality assessments (C-SSRS).Efficacy analyses were performed on the full analysis set which included all participants who received psilocybin and had at least one post-Baseline efficacy assessment. The primary efficacy end point (change from Baseline to Week 3 in the MADRS total score) was evaluated with the use of descriptive summaries using statistics for continuous variables. Similarly, the secondary and exploratory efficacy end points were also summarized descriptively. | PMC10425429 |
Results | PMC10425429 | |||
Primary and secondary efficacy results | The mean MADRS total score at Week 3 was 16.8 (95% confidence interval [CI], 11.2–22.4) which equated to a clinically meaningful mean change from Baseline of −14.9 (95% CI, −20.7 to −9.2). This improvement was apparent at Day 2 and maintained throughout the three-week follow-up (Fig. | PMC10425429 | ||
Change from baseline in MADRS total score (full analysis set). | depression | CI confidence interval, MADRS Montgomery-Åsberg depression rating scale, SD standard deviation, SSRI selective serotonin reuptake inhibitor. Note: Baseline mean (SD): COMP360 25 mg + SSRI = 31.7 (5.77).Response (≥50% reduction from Baseline MADRS total score) at Week 3 was evident in eight (42.1%) participants and was sustained throughout the follow-up period for 63.2% at Day 2, and 57.9% at Weeks 1 and 2. The same 42.1% of participants who were responders at Week 3 were also remitters (MADRS total score of ≤10) at Week 3. Remission rates remained high throughout the follow-up period for 52.6% at Day 2, 47.4% at Week 1, and 42.1% at Week 2 (Supplementary Table The mean CGI-S score at Week 3 was 2.9 (SD = 1.84) which equates to a −1.3 (SD = 1.29) change from Baseline. Proportion of responders on the CGI-S were 42.1% at Day 2, 63.2% at Week 1, 57.9% at Week 2, and 52.6% at Week 3 [Fig. | PMC10425429 | |
Change from baseline in CGI-S score and proportion of CGI-S responders over time (full analysis set). | CGI-S Clinical Global Impressions – Severity, CI confidence interval, SSRI selective serotonin reuptake inhibitor. Number of CGI-S responders stated in bars. Note: Mean change from Baseline CGI-S score was −1.3 at Week 3.The results from per-protocol analysis of the primary end point were consistent with the full analysis set. | PMC10425429 | ||
Exploratory results | auditory alterations, depression, anxiety | Improvements in quality of life, wellbeing, anxiety, affect, and self- and clinician-reported depression were evident at all time points following psilocybin administration.Participants’ EQ-5D-3L mean total score at Baseline was 0.51 (SD = 0.333) and improved by an average of 0.18 (SD = 0.310) by Week 3. The EQ-VAS mean score at Baseline was 49.0 (SD = 17.45) and improved by an average of 13.7 (SD = 18.09) by Week 3. The GAD-7 mean total score at Baseline was 12.9 (SD = 5.94) and decreased by an average of 4.1 (SD = 4.90) by Week 3, which is considered a clinically meaningful improvement in anxiety symptoms [Fourteen participants (73.7%) were considered at least minimally improved (CGI-I score ≤3) by clinicians from Baseline to Week 3 and seven participants (36.8%) were considered responders (score or 1 or 2) at Week 3. No participants were considered worsened based on the CGI-I (score ≤5) at Week 3. See Supplementary appendix for CGI-I summary of responders (Supplementary Table Alterations of consciousness on the 5D-ASC were observed in every dimension including visual restructuralization, oceanic boundlessness, reduction of vigilance, and to a lesser extent anxious ego dissolution and auditory alterations (Fig. Summary of 5D-ASC Dimension Scores on Day 1 (full analysis set). | PMC10425429 | |
Discussion | TRD, depression, TEAE, anxiety | DRUG WITHDRAWAL | In participants with TRD, a single administration of psilocybin 25 mg with psychological support adjunctive to an SSRI demonstrated a generally favorable safety profile and therapeutic efficacy across a range of clinician and self-rated measures. Contrary to speculation in prior literature [Most TEAEs were mild, short-lived, and resolved on the day of onset without medical intervention, occurring in just over half of participants. A TEAE of blood pressure increase occurred in three participants. Effects of psilocybin on heart rate and blood pressure have been reported in the literature before [There were meaningful improvements in depression severity from Baseline to Week 3, indicating that ongoing SSRI treatment did not inhibit the therapeutic potential of psilocybin. Improvements were evident across measures of depression assessed by an independent clinician (MADRS), investigator (CGI-S), and self-report (QIDS-SR-16) and persisted from Day 2 to the end of the study. Changes were apparent in every item of the MADRS with substantial improvement in the symptoms thought to be core to depression. Consistent with these findings, exploratory measures of quality of life, wellbeing, affect, and anxiety indicated improvements from Baseline across all timepoints.Although the difference in study design limits formal comparison, these efficacy findings are similar to those from the largest phase IIb randomized controlled study of psilocybin in TRD (COMP 001) in which antidepressant withdrawal was required prior to psilocybin administration [A single study has previously examined the psychedelic effect of psilocybin co-administered with an SSRI, using controlled, randomized, cross-over design in healthy volunteers [The acute subjective effects resulting from psilocybin and linked to its agonist activity at 5-HT2A/C receptors are suggested to be critical to therapeutic response [The freedom to administer psilocybin as a treatment adjunctive to an ongoing SSRI has important implications for clinical practice. Allowing continuation of antidepressant drugs would increase treatment accessibility for those who prefer to stay on their current medication and reduce the potential negative impact of antidepressant drug withdrawal or tapering. The present study was limited by its small size, open-label design and absence of a comparator, the lack of a demographically diverse sample, and the exclusion of participants with high suicide risk or current hospitalization. It is possible that the open-label design influenced participant bias and expectations towards the study treatment, and definitive comparisons with studies that included a withdrawal from SSRIs is not necessarily valid. The findings will need to be confirmed in a larger, double-blind, comparator-controlled study.This study found that a single, open-label administration of psilocybin 25 mg led to an acceptable experience for participants with TRD when administrated adjunct to an SSRI and supports further development of psilocybin with psychological support for people with TRD. This study demonstrated the feasibility of simultaneous psilocybin administration to multiple participants as previously reported [ | PMC10425429 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41386-023-01648-7. | PMC10425429 | ||
Acknowledgements | BREDA | We sincerely thank the participants, without whom this research would not have been possible. We thank the following members of staff at COMPASS Pathfinder Ltd and Worldwide Clinical Trials for their contributions: Molly Lennard-Jones, Rachel Winzer, Batya Septimus, Merve Atli, Ozlem Redjep, Hannah Tadley, Nisha Thiara, James Bennett, Julia Forte, Niccolò Bassani, and Alexandra Novikova. The statistical analysis of the data was performed by the contract research organization (Worldwide Clinical Trials (Nottingham, UK and North Carolina, US)). A central laboratory, Eurofins Central Laboratory B.V. (PA Breda, The Netherlands), processed study laboratory samples. Review of the data, interpretation, and post-hoc statistical analyses and were performed by the sponsor. | PMC10425429 | |
Author contributions | D.F. | ADVERSE EVENTS | Conception or design of the work (G.G., E.M., L.M., C.S., S.C.S., S.W.); finalization of analysis plans (S.M., H.S., J.T.); the acquisition of the data (D.F., J.R.K., V.OK., S.KP., S.C.S., S.W.); the analysis of the data (S.M., H.S.); the interpretation of data (M.C., G.G., C.S., L.M., S.M., H.S., J.T.). All authors drafted the work, revised it critically for important intellectual content, reviewed and approved the manuscript before submission, and vouch for the adherence of the trial to the protocol, the completeness and accuracy of the data and analyses, and the reporting of adverse events. Authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy of integrity of any part of the work are appropriately investigated and resolved. | PMC10425429 |
Funding | This study was funded and sponsored by COMPASS Pathfinder Ltd, London, UK. | PMC10425429 | ||
Competing interests | neuropsychiatric disorders | CEREBRAL PALSY | A contract research organization (Worldwide Clinical Trials), paid by the sponsor, supervised the conduct of the trial under the direction of the sponsor. An independent contract research organization (Worldwide Clinical Trials) were responsible for conducting MADRS assessments with blinded remote raters. The analysis of the data was performed by the contract research organization (Worldwide Clinical Trials); and the interpretation of the data was performed by the sponsor. GMG has consulted for Beckley Psytech, Boehringer Ingelheim, Clerkenwell Health, EVApharm, H Lundbeck A/S, Janssen Global Services, Novartis, Ocean Neurosciences, P1vital, Sage Therapeutics, Servier, Takeda and WebMD. GMG, MC, LM, SM, HS, CS, SCS, JT, SW, and EM are current or past employees of COMPASS Pathfinder. GMG, MC, LM, SM, HS, CS, JT, SW, and EM own shares or options in COMPASS Pathfinder. DF has received grant funding from MindMed, Neurolief, Perception Neuroscience, and Relmada Therapeutics. DF holds a patent for psychedelic drug treatment of neuropsychiatric disorders and cerebral palsy. DF, JRK, VOK, and SK-P were site investigators or sub-investigators for COMPASS Pathfinder during the clinical trial and received funding to conduct the study, and SK-P is a consultant for COMPASS Pathfinder, providing therapist training and mentorship, and clinical development. JRK has consulted for Clerkenwell Health and has received grant funding from the Health Research Board (ILP-POR-2022-030). | PMC10425429 |
References | PMC10425429 | |||
Materials and methods | Using a single-blinded parallel group randomized controlled trial design, 68 volunteers were assigned to either a study group (SG) or a control group (CG). The SG received information about oral health during pregnancy via Snapchat, while the CG received the same information using WhatsApp. The participants were assessed three times: T1 prior to the intervention, T2 immediately following the intervention, and T3 as a follow-up 1 month later. | PMC9934359 | ||
Results | A total of 63 participants completed the study in the SG or CG. According to paired t-test, total knowledge scores in the SG and CG increased significantly from T1 to T2 ( | PMC9934359 | ||
Conclusions | Using social media (e.g., Snapchat and WhatsApp) as a health-promoting intervention is a promising method for improving women’s knowledge about oral health during pregnancy for short term. However, further studies are needed to compare social media with conventional standard lecturing methods. also, to assess the longevity of the impact (short or long term). | PMC9934359 | ||
Data Availability | All relevant data are within the paper and its | PMC9934359 | ||
Introduction | tooth mobility, xerostomia, granuloma, caries | XEROSTOMIA, PREGNANCY GINGIVITIS, GRANULOMA, CARIES | Social media is defined as any of a collection of applications that use the internet to create technical and ideological foundations that permit generating and sharing of content [Pregnancy is a unique health phase in a woman’s life, as it is influenced by complicated physiological changes that can have a negative impact on the mother’s oral health such as pregnancy gingivitis, pregnancy granuloma, caries, xerostomia, and tooth mobility sometime [There is growing interest in using social media and mobile health applications to improve pregnant women’s well-being [One of the most famous social media platforms is Snapchat. Snapchat is typically used to post selfie photos and videos among friends and family in a relaxed manner as a substitute for messaging [ | PMC9934359 |
Aim | The aim of this study was to evaluate the effects of social media (specifically Snapchat) health-promoting interventions on oral health knowledge during pregnancy among pregnant women. | PMC9934359 | ||
Materials and methods | PMC9934359 | |||
Study design and participants | This study used a single-blinded parallel group RCT design in which study group (SG) participants received information about oral health during pregnancy via the Snapchat mobile application. Only participants were blinded, while examiners and statistician were not. The participants in the control group (CG) received the same information as a written flyer, as shown in " | PMC9934359 | ||
Participant interaction flowchart. | CONSORT guidelines were used to document this study. The participants were all pregnant women living in Saudi Arabia (at any city), and they were recruited using convenience sampling through invitations to social media groups about pregnancy in Saudi Arabia. This includes WhatsApp, Twitter, and other social media platforms. The invitation included the study information and invited only pregnant women to respond to the invitation, by giving initial acceptance. Recruiting started at 20/11/2021. The inclusion criteria were (a) pregnant women in Saudi Arabia, who (b) spoke Arabic, (c) were able to use Snapchat and WhatsApp social media platforms, and (d) approve the study consent form. The participants did not know each other, and they were not treated before by the research team in the dental clinic, this to avoid the intervention contamination. The research team excluded all participants who did not sign the consent form that presented the study agreement, or anyone who was not fulfilling the other inclusion criteria The WhatsApp mobile application was used to communicate throughout the study because it is one of the most common messaging methods used in Saudi Arabia and is widely accepted. WhatsApp also has end-to-end encryption for maintaining participants’ confidentiality [Where ES stands for effect size. As the study power of 90% was used, and a = 0.05, B = 0.1, constant Z(β−1) = 1.282, and constant Z (1−a/2) = 1.96. The standard deviation (SD) of a previous study on a related topic was 3.06 [ | PMC9934359 | ||
Setting | blindness | BLINDNESS | After an initial agreement to participate in the study, an invitation was sent as a message to potential participants’ mobile phones using the WhatsApp platform, which allowed for communication between the participants and the research team and sending or receipt of the consent, intervention/CG flyer, and the online questionnaires.The participants were randomly assigned to either the SG or the CG by the research team. The simple randomization process consisted of previously shuffled sealed envelopes with numbers with an equal allocation ratio placed in a bowl. Each participant randomly chose an envelope number virtually, giving them an equal chance of being placed in either group. The sealed envelopes were opaque and numbered in a sequence to ensure allocation concealment. To achieve blindness, the participants were told that the study’s goal was to examine two ways of information delivery meant to improve oral health knowledge among pregnant women. The research team used WhatsApp to give the participants a link that contained the study consent form and the baseline questionnaire (T1). Then, the participants in the SG received a barcode to add the intervention’s Snapchat account. The participants were assessed three times: T1 prior to the intervention, T2 immediately following the intervention (at the same day), and T3 for follow-up 1 month later to assess their retention of the information. | PMC9934359 |
Intervention and control | The trail started at 03/11/2021. Participants in the SG received information regarding oral health during pregnancy using the Snapchat mobile application. The oral health information was retrieved from previous studies [The stories were presented as a diary of the research team members, like most of the stories on Snapchat. The research team performed roles within the clinic of the dental teaching hospital at Umm Al-Qura University for dental chair settings, precautions with radiographs, materials that are likely to be used during dental treatments, and demonstration of dental flossing and toothbrushing. The participants received the content spontaneously throughout the intervention days. At the same time, the CG received the same information in a written flyer sent only once via WhatsApp. | PMC9934359 | ||
Assessment | Questionnaires in a self-reported soft copy format were distributed to both groups at the three time points previously discussed: T1, T2, and T3. All identifiable data used to match participant data in T1, T2, and T3 were discarded after completing the T3 data collection. The questionnaires were identical for both groups at T1 and T3. At T2, the questionnaires were similar, but participants in the SG had an additional section assessing their experiences using Snapchat as a method of information delivery, while the CG received the same questions to assess the use of WhatsApp as a method of information delivery. The questionnaires contained sections that collected demographic information, use of social media, oral health knowledge among pregnant women, and experiences and perceptions of the social media intervention, as shown in " | PMC9934359 | ||
Contents of questionnaire at T1, T2, and T3. | The first part of the questionnaire included questions to collect demographic information on age, marital status, education level, family monthly income, regular visits to a dentist, number of children, month of current pregnancy, and sources of dental information. The second part included questions about the use of social media, average hours spent on social media per day, the most-used social media platform, and average hours spent on Snapchat and WhatsApp per day. The third part assessed knowledge about oral health and dental setting treatments for pregnant women with 20 questions answered with yes, no, or I do not know. Each question had only one correct answer, and the scores for correct answers were totaled into the total knowledge score, with the highest score of 20 points (highest level of knowledge) and the lowest score of zero (no knowledge at all). The research team formulated the questions based on the information provided in the intervention for the SG and CG. The last section assessed the participants’ experiences and perceptions of the social media used in the study (Snapchat or WhatsApp). This part contained 10 statements, with answers ranging from 1 (strongly disagree) to 5 (strongly agree). Most of the questions in this last section were adapted with modifications from a previous study [The Snapchat videos and WhatsApp flyer were prepared two times before their final versions. The final version of the interventions, including the Snapchat videos, WhatsApp flyer, and questionnaire, went into a pilot study with 12 participants to validate the content, spelling, syntax, organization, clarity, grammar used in the questions, and audience comprehension. The content validation was done as the participants in the pilot were asked to the read the question, then to say it their way to be sure that the content is identical to the question content. The participants in the pilot round were not included in the main study analysis. | PMC9934359 | ||
Incentives and ethical considerations | MINOR, -11 | After data collection at T3, all identifiable data were completely discarded. Participation was voluntary, and as an incentive, the participants were entered into six separate random prize drawings for 50 Saudi Riyals (USD 13.33) in the form of local bookstore gift cards. Before participating in the intervention, all participants have to approve the study’s informed consent form, by clicking “approve” on the electronic consent format. No witness was there to witness their approval, as their participation was done electronically. There are no minor participants in this study. The study was approved by the institutional review board of Umm Al-Qura University with the number HAPO-02-K-012-2021-11-810, which follows Declaration of Helsinki. This study was registered in the ISRCTN registry with the number ISRCTN13915540 (registration data 10/11/2021), which can be accessed at | PMC9934359 | |
Data analysis | The statistically significant level was set at 0.05. The data were gathered, tabulated, and statistically analyzed using SPSS software package version 27 (IBM Corp., Armonk, NY, USA). Chi-square, t-test, Fisher’s exact test, and paired t-test were used to analyze the data collected in this study. The family monthly income question had three categories based on previous researches conducted by the principal investigator on the Saudi population [ | PMC9934359 | ||
Results | A total of 90 participants were invited to this study, but only 68 agreed to participate (response rate = 75.55%). The randomization process yielded 34 participants in the SG and a similar number in the CG. A total of 5 participants dropped out of the study, resulting in 30 participants in the SG and 33 participants in the CG, as shown in | PMC9934359 | ||
Demographic variables of the pregnant women in this study. | PMC9934359 | |||
Frequency of using social media by pregnant women in Saudi Arabia in the current study. | " | PMC9934359 | ||
Mean knowledge scores of the pregnant women in the study and control groups at T1, T2, and T3. | Using independent t-test, no significant differences were found between the SG and CG at T2 (t(61) = −1.148, The total knowledge score in the SG increased significantly from T1 to T2 with t(29) = −6.304, " | PMC9934359 | ||
Changes in total knowledge scores over time. | PMC9934359 | |||
Differences in total knowledge scores of the pregnant women at T1, T2, and T3. | " | PMC9934359 | ||
Study participants’ responses to receiving information in Snapchat (study group) or WhatsApp (control group). | PMC9934359 | |||
Discussion | The aim of this study was to evaluate social media (Snapchat) health-promoting interventions on knowledge about oral health during pregnancy among pregnant women in Saudi Arabia. The findings revealed that participants in both the study and control groups had significant improvements in their knowledge immediately after the intervention, and their retention of the information after 1 month was significantly better than their baseline knowledge. There was no significant difference between the SG and CG in knowledge improvement. The scores for the experience items regarding the intervention were higher than the midpoint for all items in both groups, but there was no significant difference between the SG and the CG on any item.The results of previous interventional studies were similar to our study [In the study design we planned to use WhatsApp to provide the same information among participants in the CG as an active comparison. This is because using WhatsApp in Saudi Arabia is observed to be very popular way to share information personally and even in work. Even health promotional materials are shared as text, flayer or infographic using WhatsApp, as form of digitalization of printed flyers used in the past years. In fact, printed flayers were one of the standard methods to increase the knowledge about health issue in Saudi Arabia. However, we did not consider using WhatsApp as another social media intervention. The main aim of our study was not to compare video contents to written contents, nor comparing the techniqual characteristics of Snapchat. However, the aim was to assess the experience of receiving the health information via Snapchat. This is because Snapchat have unique characteristics and unique interaction with audience [It should be noted that researchers in Germany have found differences in how social media applications affect our health [Because our results did not find a significant difference between the Snapchat and WhatsApp social media platforms, it can be supposed that there is not much difference in the effectiveness of one platform over another. However, it could be argued that the results of the CG are inflated. This is because the participants in the CG received the study’s flyer (one page) that contained all the intervention information that was stored on their devices. Thus, participants in the CG could refer back to the information to answer the questionnaire at T2 and T3 much easier than participants in the SG, where the information was found in the middle of Snapchat videos. In fact, a recent study found that WhatsApp was a good method of disseminating information in Pakistan about COVID-19 [Based on the findings of this study and prior studies in the literature [Additionally, we want to highlight that our intervention was simple and that the content used can be replaced by other content to enhance oral health education. Nevertheless, further research is recommended to validate this argument as it is not clear whether using social media as a venue to improve oral health is more effective than standard methods of disseminating information, such as lectures.As the aim of this study was not to assess the prevalence of knowledge of pregnant women toward oral health knowledge, we did not include a thorough analysis about the questionnaire items and their results, which is available by the corresponding author upon request. The low sample size of the participants might give a false implication on emphasizing item by item discussion. Thus, we only included our discussion to the main aim of the study.The strengths of this study include the study design, a single-blinded RCT, which is considered one of the most reliable study designs [ | PMC9934359 | ||
Conclusion | Social media (Snapchat and WhatsApp) seem to be promising tools for promotional interventions to improve public health and dental knowledge among pregnant women, as well as with other health care topics. However, Snapchat is not superior to WhatsApp in terms of effectiveness. Snapchat is easy and popularly used among people with different socioeconomic statuses, and it was found to result in good retention of oral health knowledge for short term. Nevertheless, further studies are needed to generalize this study’s results, and to assess the longevity of such intervention (short- or long-term impact). This might give better insight to invest more in such interventions in the future. | PMC9934359 | ||
Supporting information | PMC9934359 | |||
Study protocol in details. | (PDF)Click here for additional data file. | PMC9934359 | ||
Study raw data. | (PDF)Click here for additional data file. | PMC9934359 | ||
List of abbreviations | Control groupRandomized controlled trialStandard deviationStudy group | PMC9934359 | ||
References | PMC9934359 | |||
Abstract | PMC10315809 | |||
Background | breast cancer | BREAST CANCER DIAGNOSIS, BREAST CANCER | Breast cancer diagnosis and treatment increase the potential psychological impact on breast cancer survivors (BCS). The objective of this study was to assess the effects of an interdisciplinary intervention during follow‐up in BCS and identify variables related to improvements in HRQoL. | PMC10315809 |
Materials and Methods | depression, generalised, anxiety | In a non‐randomised quasi‐experimental design performed on an outpatient basis in a hospital gynaecology and oncology unit, 60 BCS were assigned to an interdisciplinary experimental group (EG) or a usual care group (CG). The EG underwent 12 sessions of an interdisciplinary program which included Mindfulness and physiotherapy, for 120 min per day, once a week for 6 weeks. At baseline, at 6 weeks and at 3 months after the intervention, participants of EG and CG completed an assessment of HRQoL (EuroQol and EORTC‐QLQ‐C30) and symptomatology of anxiety and depression. Additionally, EG completed an assessment of satisfaction with the treatment. For data analysis, we used descriptive statistics, Wilcoxon test, Kruskal–Wallis test, Chi‐square and Fisher tests and generalised linear models. | PMC10315809 | |
Results | depression, anxiety, fatigue, pain | After 6 weeks, statistically significant differences were apparent in global and cancer‐related health symptoms such as fatigue and pain in the EORTC QLQ‐C30 and in anxiety and depression, among the EG ( | PMC10315809 | |
Conclusions | depression, 6‐week, anxiety | The results of our study suggest that a 6‐week interdisciplinary intervention may improve HRQoL and symptomatology of anxiety and depression in BCS patients at 3 months. The study presents data that the intervention for BCS appears promising and warrants further study in a randomised controlled trial.
| PMC10315809 | |
INTRODUCTION | cancers, breast cancer, cancer, tumour, Cancer | CANCERS, RECURRENCE, BREAST CANCER, CANCER, DISEASE, TUMOUR, CANCER | Although breast cancer (BC) remains a highly prevalent form of cancer in women around the world, advances in early diagnosis and treatment have resulted in increased survival. In Spain, it remains the most frequent tumour among women and is one of the cancers with the highest rate of incidence, mortality and recurrence at 5 years.The majority of women diagnosed with early BC undergo treatment involving surgery and radiotherapy, chemotherapy and/or hormonal therapy, which is associated with a substantial burden of symptoms and impacts quality of life. Cancer survivors experience many adverse outcomes related to the disease or its treatment,A Danish population‐based cohort study of cancer survivors found that the need for psychological and physical rehabilitation was equally frequent.Tremendous interest has been generated in the association between exercise and physiological and psychological well‐being in general and HRQoL in particular. As far as we know, there have been relatively few multidisciplinary interventions for cancer patients and survivors in Spain. In particular, no studies have investigated the effectiveness of a coordinated psychological and physiotherapeutic intervention.In our opinion, given the high prevalence of BC and the negative impact on patient's HRQoL, methodologically rigorous interdisciplinary treatments should be developed and implemented that are specifically designed for breast cancer survivors (BCSs). We developed an interdisciplinary treatment for BCS based on the biopsychosocial model,The chief objective of this study was to evaluate the effects of an interdisciplinary (psychological and physiological) group intervention for BCS compared with standard treatment. A further aim was to identify factors predicting improvement in HRQoL among these patients. | PMC10315809 |
MATERIALS AND METHODS | PMC10315809 | |||
Subjects | psychiatric | ORGANIC DISORDER | The study population was drawn prospectively from patients who had been referred to the gynaecology and oncology unit of Galdakao‐Usansolo Hospital. Women aged over 18 who had been diagnosed and treated for BC 2 years earlier were included. Patients who declined to participate in the study or were suffering from a severe psychiatric or organic disorder interfering with their ability to complete the questionnaires were not included. Patients were recruited between January 2016 and January 2017. The study received approval from the institutional review board of Galdakao‐Usansolo Hospital. All participants provided written informed consent. All information was kept confidential. This study forms part of the CaMISS‐study, an observational analytic prospective cohort study (Clinical Trials.govIdentifier:NCT02439554), and the study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki (6th revision, 2008). | PMC10315809 |
Study design and intervention | BREAST CANCER | We used a non‐randomised quasi‐experimental design.A total of 87 BCS were invited to participate in the study. Of these, 60 women who had survived BC voluntarily agreed to take part in the study (Figure Flowchart of the sample of patients with breast cancer. CG, Control Group; EG, Experimental Group. | PMC10315809 | |
The interdisciplinary group intervention | The In the | PMC10315809 | ||
Instruments and data collection | PMC10315809 | |||
Clinical data | PATHOLOGY |
Related to patients' personal background.Related to the care process.Related to neoadjuvant treatment.Related to anatomical pathology.Related to follow‐up at 2 years and adjuvant treatment. | PMC10315809 | |
Patient‐reported measures |
The self‐report version of the
To determine the patients' opinions of the intervention they had received, an ad‐hoc | PMC10315809 | ||
Statistical analysis | generalised, depression | Descriptive statistics included frequencies and percentages for categorical data and means and standard deviations for continuous variables. Differences between experimental and control groups were evaluated using the Chi‐square or Fisher exact test for categorical variables and Student In all the questionnaires, the differences between baseline and 6 weeks and baseline and 3 months after intervention were calculated; the Wilcoxon signed‐rank test was used. Differences between the groups were evaluated by means of the Student After a univariable analysis to identify factors related to the change in global health status measured by the EORTC‐QLQ30 between the baseline score and the score at 6 weeks and 3 months, a multivariable generalised lineal model was performed. Group of patients, global health status at baseline measured by EORTC‐QLQ‐C30, social functioning at baseline measured by EORTC‐QLQ‐C30 and depression at baseline measured by HADS, were the factors included in the final multivariable generalised linear model. All those variables with a All effects were considered statistically significant at | PMC10315809 | |
RESULTS | BREAST CANCER | The study sample comprised 87 patients with BC. Of these, 60 patients agreed to participate; all completed the instruments at baseline and 6 weeks and 3 months following the intervention (Figure Table Baseline data on patients with breast cancer, by group (experimental or control).Abbreviations: Data are given as median [interquartile range]. Level of significance Data are given as median [minimum‐maximum].Six weeks after intervention, a statistical improvement was observed in the EG in general HRQoL(Table Change and effect size of the questionnaires between baseline and 6 weeks and 3 months, between experimental and control groups.
Abbreviations:
The results of the The results of the Multivariable model of health‐related quality of life at 6 weeks and 3 months after treatment.
Abbreviations: —, not applicable; Moreover, patients who received the interdisciplinary intervention reported being | PMC10315809 | |
DISCUSSION | anxiety, fatigue, cancer, 6‐week, pain, depression | CANCER, DISEASE, RECURRENCE | To summarise, BC and its treatment pose many challenges to the patient's physical, emotional, mental and social well‐being and negatively impact the patient's QoL. Furthermore, HRQoL and its domains are important measures for cancer survivorship as they provide prognosticAn interdisciplinary treatment that included coordinated psychological and physiotherapeutic interventions improved HRQoL, anxiety and depression among BCS 6 weeks and 3 months after the interdisciplinary treatment, when compared to the usual treatment for such patients. To our knowledge, this is the first trial conducted in a group setting in a hospital environment in the Basque Country that assesses the efficacy of an interdisciplinary treatment for BCS. This study investigated changes in HRQoL, anxiety and depression after a 6‐week interdisciplinary intervention in 60 BCSs. Additionally, the baseline scores of HRQoL, depression and social functioning and the study group were significant variables related to improvement of HRQoL.Even following the completion of treatment for BC, survivors regularly suffer severe psychological stress, anxiety, depression, fear of recurrence, physical pain, fatigue and reduced QoL.Our results are consistent with those of previous studies,Although all patients in our study had early BC, the emotional response to BC is not dependent on the stage of the disease, given that women who have been diagnosed with non‐invasive BCs also experience powerful emotions.Three months after completion of the interdisciplinary intervention, patients continued to show statistically significant improvements in With regard to When interpreting the results in terms of ES, the ES for HRQoL, anxiety and depression were large (With regard to variables It is important to stress that the EG patients in our study reported being Our findings support the preliminary evidence that interdisciplinary treatment can be significantly efficacious in alleviating anxiety and depression and improving HRQoL in women survivors of BC. Moreover, the ES is large. Our purpose was to furnish patients with the skills that would assist their long‐term adaptation to BC and improve their HRQoL.One limitation of this research is that only a small number of BCSs were included. Because the women were not allocated randomly to the program, it is difficult to draw conclusions drawn from the results of the study. Although a good balance between the groups was maintained with regard to disease, treatment and demographic variables, patients with anxiety (66%) were more likely to accept an interdisciplinary intervention; that is, there is a group of patients who have been diagnosed and treated for BC, who have shown elevated levels of symptomatology of anxiety and depression within 2 years (approximately) of their cancer diagnosis, which prevents a valid comparison between the two groups. Although this study was not undertaken as RCT, which is a very substantial limitation, the significant ESs that we observe in the EG are exciting and the intervention does warrant further study in a randomised controlled trial. A limitation of our study was that there was no included the molecular subtypes of BC. Another limitation is that the lack of standard interdisciplinary treatments for BCSs and standard study designs hinders comparison between our study and others. Another limitation is that the majority of the sample (72%) were stage 0 and 1. A limitation is that there was no assessment of satisfaction in the standard care group. Another limitation was that few patients received anti HER2 treatment in the EG. Finally, future longitudinal research in a large sample is needed for BCSs and to observe ways in which the interdisciplinary treatment can be applied clinically. | PMC10315809 |
AUTHOR CONTRIBUTIONS | PMC10315809 | |||
FUNDING INFORMATION | Cancer | CANCER | This study was partly financed by funds awarded by the Asociación Española Contra el Cáncer (Spanish Association Against Cancer, Junta de Bizkaia) (AECC14/901) and the Carlos III Health Institute (PI12/01842) to principal investigator Susana García, and the University of the Basque Country UPV/EHU. | PMC10315809 |
CONFLICT OF INTEREST STATEMENT | The authors declare that they have no competing interests. | PMC10315809 | ||
ETHICAL APPROVAL STATEMENT | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration, subsequent amendments thereto and comparable ethical standards. | PMC10315809 | ||
CLINICAL TRIAL REGISTRATION NUMBER | NCT02439554. | PMC10315809 | ||
Supporting information |
Figure S1
Click here for additional data file.
Table S1
Click here for additional data file.
Table S2
Click here for additional data file.
Table S3
Click here for additional data file. | PMC10315809 | ||
ACKNOWLEDGMENTS | breast cancer | BREAST CANCER | The authors wish to thank the Research Committee of Galdakao‐ Usansolo Hospital for its help in editing this article. We also acknowledge the editorial assistance provided by Tim Nicholson. We are particularly grateful to the women with breast cancer who collaborated in our research. | PMC10315809 |
DATA AVAILABILITY STATEMENT | The data that support the findings of this study are available from the corresponding author at email direction ( | PMC10315809 | ||
REFERENCES | PMC10315809 | |||
Abstract | PMC10098273 | |||
Objectives | This study aims to evaluate the effectiveness of two different distraction techniques (Audio Video Distraction/Video Game Distraction) in the management of anxious pediatric patients during dental treatment. | PMC10098273 | ||
Materials and Methods | pain | GROUP B | One hundred and five children were randomly divided into three groups; Group A: active distraction using video games on a tablet device and wireless joystick (VG). Group B: passive distraction using video on tablet, and wireless headphones (AV). Group C (Control group): basic behavior guidance technique Tell Show Do was used (C). The children were selected from the department of pediatric dentistry at the Faculty of Dentistry, Damascus University, who required pulpotomy in primary mandibular molars. All children were assessed by: Simplified Wong‐Baker FACES for pain scale (self‐report), and “HOUPT” Behavior Rating Scale for Overall Behavior (non‐self‐report), at the end of treatment. | PMC10098273 |
Results | pain | One hundred and five children completed the study (57 boys and 48 girls) aged between 6 and 10 years (mean age of 7.4 years). The active distraction (VG) group was superior to the passive distraction (AV) group and the control group (C) on the pain scale with statistically significant differences as appeared in Simplified Wong‐Baker Scale ( | PMC10098273 | |
Conclusion | anxiety, pain | POSITIVE | Positive distraction with video games by wireless joystick displayed on the portable tablet on the dental chair was the best technique for reducing dental anxiety and reported pain in school children (6‐10 years) and was better than negative distraction by video cartoons on the tablet device.
This clinical trial was approved by | PMC10098273 |
INTRODUCTION | behavioral disturbance, hearing and vision, anxiety, pain | The foundation of pediatric dental practice is the ability to establish a good dental experience (Avery's et al., For many years the process of leading a child in the dental clinic was called “behavior management” but in 2005 the term “Behavior Guidance” was adopted in the recommendations of the American Academy of Pediatric Dentistry (AAPD) to emphasize that the goals of behavior guidance are not to “deal with” the child's behavior but to establish communication with the child and with his parents to obtain good oral health (Avery's et al., Distraction is a technique that dissipates the child from the painful stimulus and allows for successful and high‐quality treatment (Al‐Khotani et al., The number of clinical studies on the effectiveness of the distraction technique in the management of dental fear and anxiety in children and adults during dental treatment is very low, and there is no consensus in methodologies and research results, which indicates the need for more controlled clinical studies on this technique (Prado et al., Distraction is defined as a behavior management technique that relieves pain and behavioral disturbance by diverting children's attention away from painful stimuli during extensive dental procedures (Aminabadi et al., The distraction can be negative or positive (active or passive), where audiovisual distraction is a type of negative distraction that affects two types of senses, hearing and vision, while playing video games is a positive distraction that affects an additional sense, which is the kinesthetic sense (Allani & Setty, Active distraction depends on the child participating in certain activities during the procedures and includes singing songs, pressing a ball with the hand, taking deep breaths, and playing with electronic devices (Srouji et al., | PMC10098273 | |
MATERIALS AND METHODS | PMC10098273 | |||
Study design | This study was designed as a randomized controlled trial (RCT) to compare the effectiveness of (VG) distraction and (AV) distraction to a control group during pulpotomy in primary mandibular molars in 6–10‐year‐old children.This clinical trial was conducted in the Department of Pediatric Dentistry at Damascus University in protocol record (IRB No. UDDS‐1987‐15082019/SRC‐1450) and approved by | PMC10098273 | ||
Sample size calculation | The sample size was calculated using G‐Power 3.1 statistical program with ( | PMC10098273 | ||
Patient selection | DISORDERS | Children were selected from the Department of Pediatric Dentistry, Damascus University, Faculty of Dentistry, based on the following inclusion criteria:
Children required pulpotomy in a primary mandibular molar.Aged between 6 and 10 years.Children were categorized definitely positive or positive ratings on the Frankl scale.Exclusion criteria:
Children with a previous dental experience.Children with systemic or mental disorders. | PMC10098273 | |
Randomized allocation | The children were randomly assigned according to the website | PMC10098273 | ||
Intervention | AIDS, GROUP B | The pulpotomy technique was performed for all children following the standard protocol and the groups were divided according to the method of distraction (Figure Group A: (VG) active distraction with using video games on a tablet device, wireless joystick, and wireless headphones.Group B: (AV) passive distraction with using video on tablet and wireless headphones.Group C: (C) Control group with basic behavior guidance techniques (tell show do) and without using any type of distraction aids.The child was interviewed, examined, and his degree of cooperation was evaluated according to the Frankl Behavior Rating Scale definitely positive or positive. After the child sat on the dental chair, he was chosen the electronic game for the (VG) group and the cartoon film for the (AV) group.For group A (VG): The children were taught how to play through a wireless controller (joystick) and put on wireless headphones, then played for 5 min before starting the treatment and continued to play during the entire procedure.For group B (AV): The child watched his favorite movie for 5 min before starting the treatment with headphones and continued watching during the entire procedure.For group C (C): The traditional methods of managing behavior were followed without any intervention. The technique (Tell ‐ Show ‐ Do) was followed. | PMC10098273 | |
Pain assessment scale | pain | The Simplified Wong‐Baker FACES pain rating scale was used in this study due to the reliability that was proved by Haji‐Bakr‐and AL‐monakel (Haji. Baker Rasha, After completing the dental treatment and removing the rubber dam, the children were immediately asked to fill a face of the scale that described how they felt during the procedure while they was still on the dental chair in the treatment room (Figure | PMC10098273 | |
Behavior assessment scale | pain | The Behavior Rating Scale “HOUPT” for Overall Behavior. The external observer was selected 1 of the 6 scales at the end of treatment. Scales are shown in (Figure Different techniques used in the study: (a) active distraction, (b) passive distraction, and (c) Tell‐Show‐Do.Consort flow diagram.Simplified Wong–Baker FACES pain rating scale (Baker & Bashir al‐Mangal, “HOUPT” Scale for overall behavior. | PMC10098273 | |
Statistical analysis | The statistical analysis was carried out using SPSS 24.0. One‐way ANOVA was used to study the differences between the three groups according to behavioral scale scores (HOUPT score, Simplified Wong‐Baker faces scale). | PMC10098273 | ||
RESULTS | T‐test, pain | GROUP B | A total of 105 children, (57 boys and 48 girls, mean age 7.4) completed the study. In all groups, pain and behavioral scale scores (Simplified W‐B Faces, HOUPT) were recorded. One‐way ANOVA statistical test was done, and a significant difference was noticed between three groups on the overall behavior scale One‐way ANOVA to study the difference in three groups (There was a statistically significant difference in pain scale between Group A (VG) and Group B (AV) (Bonferroni test for multiple correction comparison for pain reportingThere was a statistically significant difference in the overall behavior scale between Group A (VG) and Group C (C) (Bonferroni test for multiple correction comparison for overall behavior (This indicates that the use of video games with joystick and portable tablet added a significant improvement in the behavior of children and reduce the self‐reported pain during the primary mandibular molar pulpotomy.All connections were via Bluetooth and we did not use any wired devices so that the workspace remained empty and didn't interfere with the movement of the doctor's hands.There were no statistically significant differences between males and females in three groups according to the scales used in the research HOUPT Scale and W‐B Scales, as shown in (Table T‐test in Group(B)(V) multiple correction comparison for overall behavior ( | PMC10098273 |
DISCUSSION | vomiting reflex, Inferior Alveolar Nerve Block, anxiety, pain | POSITIVE | Dental fear and anxiety have an impact on the quality of dental treatment (Milgrom et al., Therefore, many procedural, behavioral, and nonpharmacological techniques have been proposed to reduce pain and discomfort during pediatric dental treatment. This study was conducted to compare different distraction techniques (active distraction–passive distraction) in reducing perceived pain during pulpotomy in children.There are many scales for classifying behavior in children, the most famous of which is the Frankel Scale, which divides behavior into four categories (Definitely negative, Negative, Positive, and Definitely positive) (Dean, This study dealt with a new technique that a child plays video games through a wireless joystick linked via Bluetooth with a portable tablet on the dental chair and placing Bluetooth headphones during pulpotomy, starting from IAN injection (Inferior Alveolar Nerve Block) and ending with the final restoration, because of the use of Bluetooth Dental treatment usually includes painful procedures, repetitive injections, use of sharp tools at high speed, and frequent visits. These aspects affect the child's ability to tolerate treatment, which poses a challenge to the dentist and, therefore, it is difficult to achieve successful dental treatment if the child's behavior is not controlled technology and wireless devices, the workspace was comfortable for the dentist and did not interfere with the movement of his hands, The tablet was placed in a high position on the dental chair, so the child raised his head high, which facilitated treatment.As our study results show, the use of the joystick and video games added a significant improvement in the behavior of children and the self‐reported pain during the dental treatment procedure, so that all children in active distraction group were treated with acceptable and satisfaction general behavior according to the scales used in the research. Thus, our method of distraction outperformed the passive distraction using video films. this is due to the physical activity of the child and they were blocked out from the surrounding environment, and our results agreed with many research that have been studied the effectiveness of active distraction through video games on a tablet device while performing different dental procedures, and their results showed that active distraction is superior to passive distraction (Attar & Baghdadi, In addition, active distraction using the joystick, which was fixed to the dental chair, was superior in pain control during pulpotomy compared to using AV distraction and control group, but it was similar in child behavioral management during pulpotomy compared to using AV distraction.Active distraction using video games is superior to passive distraction using video games for pain described by children, although other studies used an effective technique in improving self‐reported pain, PlayStation video games did not affect overall behavior (Guinot et al., Some studies have found that playing video games has improved a child's adaptation to the dentist, compared to watching cartoons while injecting local anesthesia. In addition, playing a video game and watching cartoons film during dental treatment reduced heart rate, compared to traditional distraction techniques (Kumprasert et al., On the other hand, some studies used effective distraction in reducing the vomiting reflex while taking the upper and lower alginate impression, and they used the Intellectual Colored Game, which distracted the child's attention during the stressful alginate impression (Kulkarni et al., In contrast to our study, some studies found that distraction did not provide additional advantages in reducing fear and pain when compared to traditional methods such as directing behavior and positive reinforcement, but it is a way to attract the child's attention and activate the child's nervous and emotional centers, which leads to relaxation (Al‐Khotani et al., This study found that playing a video game during dental treatment could better method a child's cooperation with the dentist, compared with watching cartoons and other conventional distractions (Cozzi et al., | PMC10098273 |
CONCLUSION | anxiety, pain | Within the limits of this study, it can be concluded that the use of video games via joystick on tablets and headphones gave the best result in relieving dental anxiety and pain during pulpotomy in children.Although the use of cartoon films through the tablet and headphones did not reduce the described pain in children, it was acceptable in managing children's behavior when performing the dental treatment and may lead to desirable behaviors in future visits. | PMC10098273 | |
DETERMINANTS | BLIND | A limitation of this study was the inability to blind the external investigator from the use of joystick and headphones, and the unacceptability of some children to use joystick and headphones. | PMC10098273 | |
AUTHOR CONTRIBUTIONS | Ekram AlSibai conceived the idea and provided the treatment. Ekram AlSibai contributed to the writing. Hasan Alzoubi to the documenting. Nada Bshara conceived the idea and supervised the treatment. Laith Al Sabek contributed to study design. | PMC10098273 |
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