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Amendments from Version 2 | EVENT, SECONDARY | [version 3; peer review: 2 approved]No competing interests were disclosed.
Abstract
Background
Childbirth is a life-transforming intense event to a woman and her family. Even though a variety of non-pharmacological techniques are readily available to alleviate the distress of women in labour, the majority of women ar... | PMC10359740 | |
Introduction | pain | EVENT | The health and well-being of mother and child during pregnancy and childbirth are public health concerns because both of them have special needs, which cannot be catered to by general health services.
Childbirth is a life-transforming intense event to a woman and her family.
A systematic review on childbirth education ... | PMC10359740 |
Methods | PMC10359740 | |||
Study design | The antepartum breathing exercise program was based on the Lamaze method, with the Lamaze breathing component for use during pregnancy and childbirth. Antenatal women were recruited to a two-arm study consisting of an intervention group, who received training of the antepartum breathing exercise program in addition to ... | PMC10359740 | ||
Ethical considerations | Ethical clearance was obtained from the Institutional Ethics Committee of Kasturba Hospital, Manipal (IEC 212/2012) and the trial was registered under The Clinical Trials Registry - India (CTRI). The registration number for this trial was CTRI/2016/02/006621, registered on 05.02.2016 (Available at URL
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Participants | eclampsia, malpresentation | RECRUITMENT, PRETERM LABOUR, ECLAMPSIA, PLACENTA PREVIA, MEDICAL COMPLICATION, OBSTETRIC COMPLICATION | Women attending the antenatal clinic were eligible to participate in the study from 36 weeks of gestation. They were provided with a subject information sheet. Those women who were willing, interested, and eligible to participate, signed individual consent forms. Women were eligible to enter the trial if they had a sin... | PMC10359740 |
Randomization | We used block randomization to randomize participants into the groups. Randomization was done in a 1:1 allocation ratio to ensure equal numbers in each group. Further allocation of participants to the intervention and standard care groups was done by an outpatient nurse with the help of a sequentially numbered opaque s... | PMC10359740 | ||
Intervention | CONTRACTIONS | Five breathing patterns were introduced namely- cleansing breathing for relaxation, slow-paced breathing, modified-paced breathing and patterned-paced breathing. These patterns were used during and following contractions. Gentle pushing, and breath-hold during pushing were instructed during the second stage of labour w... | PMC10359740 | |
Images of Lambze breathing patterns. |
An educational video explaining five patterns of breathing exercises was shown and their benefits were taught to women enrolled in the intervention group during the first appointment. These breathing patterns were demonstrated by the investigator to the women on a one-to-one basis. Women were asked to repeat these bre... | PMC10359740 | ||
Validity, reliability and rigour | birth injuries | Maternal and neonatal outcomes were measured using structured observational records on outcomes of labour. The tool consisted of 25 items that observed outcomes, which were the outcome of labour, nature of delivery, duration of labour, rate of episiotomy, augmentation of labour, gestational age at birth, birth injuries... | PMC10359740 | |
Sample size and power | RECRUITMENT | The sample size calculation was based on two independent means derived from the pilot study. The trial was designed to demonstrate minimum detectable differences in the duration of labour between two groups as one hour and anticipate an attrition rate of 10% since outcomes were measured until 40 weeks of gestation. Thi... | PMC10359740 | |
Data collection | birth injuries | The demographic data included the background information of the women’s age, period of gestation, last menstrual period (LMP), expected date of delivery (EDD), parity, years of marriage, religion, type of family, education, occupation, family income, height, current weight, and total weight gained during pregnancy. Mat... | PMC10359740 | |
Data analysis | Categorical data were expressed as frequency and percentages and analyzed with the χ
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Results | PMC10359740 | |||
Participant characteristics | RECRUITMENT | Out of 290 participants recruited, 280 participants were randomized into intervention or standard care groups. Nineteen women (2 from intervention group and 17 from the standard care group) were excluded from the study because they had elective caesarean deliveries and non-reassuring NST. Ultimately, 261 participants w... | PMC10359740 | |
Baseline characteristics of participants. | weight gain | DISORDERS | Chi-square test was used for comparison of the proportion of categorical data including years of marriage, religion, type of family, occupation, medical disorders during pregnancy. One way ANOVA was used for comparison of continuous data including age, period of gestation, haemoglobin, and weight gain. | PMC10359740 |
Primary outcome | rupture | REGRESSION, CONTRACTIONS |
A statistically and clinically significant difference was found in the onset of true labour in our study. Among 138 primigravid women in the intervention group, 98 (70%) had spontaneous onset of labour (women came with term gestation, vertex presentation and spontaneous uterine contractions with or without rupture of ... | PMC10359740 |
Onset of labour in the intervention and standard care group. | vaginal deliveries |
Women in the intervention group 67 (48%) were more likely to experience a spontaneous vaginal birth, 33% of women had induced vaginal deliveries and 19% had caesarean deliveries (
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Nature of delivery in the intervention and standard care group. | The
A statistically and clinically significant difference was found in the mean duration of labour (in hours) between intervention 5.5127 (SD 1.998) hours and standard care group 7.238 ± 3.678 hours, resulting in a mean of 132 minutes,
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Mean profile plot showing duration of labor between intervention and standard care group. | PMC10359740 | |||
Secondary outcome | PROLONGED SECOND STAGE OF LABOUR | Among 98 women in the intervention group who had spontaneous onset of labour, 68% had a spontaneous vaginal delivery with episiotomy, 18% had assisted vaginal delivery with outlet forceps due to failure of maternal power, decreased bearing down efforts and prolonged second stage of labour and 13% had vacuum delivery. W... | PMC10359740 | |
Discussion | weight gain | PRETERM BIRTH, EVENT | Findings from our study suggested that breathing patterns when done regularly during the antenatal period as well as the active phase of labour had a positive impact on outcomes of labour. Excessive interventions at the time of labour were minimized preserving autonomy and ultimately enabling women to attain self-contr... | PMC10359740 |
Limitations | HIGH-RISK PREGNANCY, RECRUITMENT, COMPLICATIONS | First, the participants were low-risk pregnant women above 36 weeks of gestation without any major complications and thus the study did not focus on the high-risk pregnancy population. Second, as it was a single-blinded study, the researcher was aware of the group assignment. Hence, a reporting bias may have occurred. ... | PMC10359740 | |
Implications for practice | The study provides policymakers with the evidence of incorporating comprehensive childbirth education that introduces women to a variety of options, which is not commonly practiced in India, especially in a setting where research was carried out. Instituting midwifery-led collaborative care services in community health... | PMC10359740 | ||
Conclusion | Considering the special needs of childbearing women, a personalized and focused protocol is best indicated, that adapts to a variety of practices, and which provides and promotes a holistic approach to health. It must also fosters participants with a framework with which they can integrate this practice during pregnanc... | PMC10359740 | ||
Data availability | PMC10359740 | |||
Underlying data | OSFHOME: Underlying data for “Effectiveness of antepartum breathing exercises on the outcome of labour: A randomized controlled trial”,
This project contains the following underlying data:
Deidentified demographic informationDeidentified comparison scores of primary outcomes between standard care and intervention group... | PMC10359740 | ||
Reporting guidelines | Figshare: CONSORT checklist for‘[Effectiveness of antepartum breathing exercises on the outcome of labour: A randomized controlled trial]’.
[CONSORT flowchart]
Data are available under the terms of the
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Author contribution | PMC10359740 | |||
Acknowledgements | The researcher is very grateful to all participants for their valuable contribution to the study. | PMC10359740 | ||
References | INBORN ERRORS OF METABOLISM |
The authors have changed the context of the questionable section providing general reasoning which would be prohibitive to the routine practice of labor care without giving references, which would not affect the validity of the study's findings.Is the work clearly and accurately presented and does it cite the current ... | PMC10359740 | |
Objectives | rheumatoid arthritis, periodontitis, RA | RHEUMATOID ARTHRITIS, PERIODONTITIS | We aimed to investigate prolactin (PRL) levels in gingival crevicular fluid (GCF), synovial fluid, and serum in patients suffering from moderately active rheumatoid arthritis (RA) with and without periodontitis (P). Further, to evaluate the effect of non-surgical periodontal treatment on these levels compared to contro... | PMC10264271 |
Materials and methods | periodontitis, RA | PERIODONTITIS | Eighty subjects were divided into 4 groups: group 1: 20 patients with RA + P, group 2: 20 periodontitis patients (systemically healthy), group 3: RA patients (periodontally healthy), and group 4: healthy controls. Patients with periodontitis received scaling and root planning (SRP). PRL was measured using enzyme‐linked... | PMC10264271 |
Results | RA | At baseline, in GCF of RA + P group showed the highest mean PRL levels, followed by P group whereas groups 3 and 4 showed a statistically less values than the first 2 groups. Serum values showed non-significant difference between the first three groups, although higher than healthy controls. SRP reduced GCF and serum l... | PMC10264271 | |
Conclusions | rheumatoid arthritis, periodontitis | RHEUMATOID ARTHRITIS, PERIODONTITIS, DISEASE | Local GCF and synovial levels of PRL seem to be linked to the disease process of both periodontitis and rheumatoid arthritis than serum levels. SRP reduced these local levels. | PMC10264271 |
Clinical relevance | RA | In patients with RA and CP, local PRL seems to play a role in the association between the two conditions; further, periodontal treatment is essential to improve periodontal condition in RA patients. | PMC10264271 | |
Trial registration | Clinicaltrials.gov. Identifier: NCT04279691. | PMC10264271 | ||
Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10264271 | ||
Introduction | inflammation, RA, periodontitis, teeth loss | RHEUMATIC DISEASES, INFLAMMATION, PERIODONTITIS, RECRUITMENT, PITUITARY, PERIODONTITIS | Hormones are involved in various aspects of the immune response and rheumatic diseases; the interest in the crosstalk between hormones and cytokines acting on inflammation and bone metabolism has recently grown [Periodontitis (P) is another chronic inflammatory disease of teeth supporting structures, mainly induced by ... | PMC10264271 |
Materials and methods | PMC10264271 | |||
Study design and ethical aspects | In this case controlled clinical trial, subjects were recruited from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry, October University for Modern Sciences and Arts (MSA) and Al-Azhar Universities and from Rheumatology Department, Al-Zahraa Hospital, Al-Azhar University, ... | PMC10264271 | ||
Sample size calculation | Sample size calculation was performed using G*Power version 3.1.9.2. Prolactin level in GCF after treatment was the primary outcome. A pilot study was conducted on three patients in each group (included in the study groups afterwards). Mean values were 22, 18.8, 17.5, and 18 for the four groups, respectively. Standard ... | PMC10264271 | ||
Study population | A detailed medical history of each participant was obtained according to the modified Cornell Medical Index questionnaire [ | PMC10264271 | ||
Inclusion criteria
| Group 1: patients with chronic moderately active RA [ | PMC10264271 | ||
Exclusion criteria | PD, RA | SYSTEMIC DISEASE | (1) Pregnancy or lactation; (2) any known systemic disease other than RA for groups 1 and 3; (3) previous periodontal treatment (surgical or non-surgical) in last 6 months; (4) antibiotics in the past 3 months; (5) previous intra-articular drug injections; (6) smoking; (7) biological DMARD therapy; (8) abnormal body ma... | PMC10264271 |
Rheumatologic examinations | RA | Diagnosis of RA was verified according to the 2010 RA classification criteria of the American College of Rheumatology and EULAR [ | PMC10264271 | |
Periodontal examination and treatment | PD | Dental clinical and radiographic examinations were performed to all study subjects. All teeth were examined excluding the third molars and implants (WHO, 1997). The following measurements were recorded: (1) clinical attachment loss (CAL), (2) probing pocket depth (PD), (3) gingival index [ | PMC10264271 | |
Fluid sampling and examination | inflammation, Periodontitis, RA, attachment loss, trauma | INFLAMMATION, PLAQUE, PERIODONTITIS | Synovial fluid and serum samples were collected the same day of baseline clinical examination whereas the GCF samples were collected the day after to avoid the contamination of crevicular fluid with blood associated with the probing of inflamed sites. Patients of all study groups provided serum and GCF samples at basel... | PMC10264271 |
Statistical analysis | PLAQUE | Numerical data were explored for normality by Kolmogorov–Smirnov and Shapiro–Wilk tests. All data showed parametric distribution except for plaque index and gingival index. Data were presented as mean and standard deviation (mean ± SD) values. For parametric data, one-way ANOVA and repeated measures ANOVA tests were us... | PMC10264271 | |
Results | PMC10264271 | |||
Clinical parameters | PD, RA | For RA parameters, a non-significant change in DAS scores after treatment was reported; mean values (mean ± SD) were 4.2 ± 0.6 and 4.1 ± 0.6 pre- and post-treatment, respectively. The mean values (mean ± SD) for ESR were 29.4 ± 3.3 and 28.1 ± 3.3 pre- and post-treatment, with a significant decrease (Table Descriptive s... | PMC10264271 | |
Discussion | periodontitis, cancer, inflammation, infection, systemic lupus, RA, active disease process | PERIODONTITIS, CANCER, INFLAMMATION, INFECTION, PSORIATIC ARTHRITIS, PERIODONTAL INFLAMMATION, MULTIPLE SCLEROSIS, LEAKAGE, PATHOLOGY, DISEASES | The present study reports, for the first time, gingival crevicular fluid, synovial fluid, and serum levels of prolactin hormone in RA patients with and without periodontitis and the effect of non-surgical periodontal therapy on these levels. We included a well distinguished group of RA patients with moderate severity, ... | PMC10264271 |
Author contribution | N.E.: original idea, writing main manuscript, review and editing, conceptualization, data analysis, project administration. Z.S., R.F., and S.A.: data collection, writing original draft, review and editing, visualization. O.S.: data collection, writing original draft, review and editing. | PMC10264271 | ||
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). The study was self-funded by the authors. | PMC10264271 | ||
Declarations | PMC10264271 | |||
Competing interests | The authors declare no competing interests. | PMC10264271 | ||
Ethical approval | All procedures performed were in accordance with the ethical institutional standards and with the Helsinki Declaration. | PMC10264271 | ||
Informed consent | Informed consent was obtained from all study participants. | PMC10264271 | ||
Conflict of interest | The authors declare no competing interests. | PMC10264271 | ||
References
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Background | Clinical Record (CR) writing is a fundamental skill for healthcare professionals, but the best e-learning methods for teaching it remain unstudied. Therefore, we investigated speech therapy students’ differences in the quality production of CR at the placement and their experience after following asynchronous or synchr... | PMC10439640 | ||
Methods | A multi-method randomised controlled trial. Fifty speech therapist students were equally and randomly divided into two groups attending asynchronous or synchronous e-learning classes to learn how to write a CR. The quality of the CR was tested through an ad hoc checklist (score 0–32) and the groups’ scores were compare... | PMC10439640 | ||
Results | ’ | INTERACTION | No score differences between the two groups were found (Cohen’s d = 0.1; 95% Confidence Interval [-0.6; 0.7]). Four themes were generated: (1) ‘Different Forms of Learning Interaction’, as the synchronous group reported a positive experience with being fed back immediately by the lecturer, whereas the asynchronous grou... | PMC10439640 |
Discussion | Asynchronous and synchronous e-learning courses appeared equally effective in teaching CR writing. However, students perceive and experience these methods differently. The choice or blend of these methods should be based on students’ needs and preferences, teacher input, as well as organisational requirements rather th... | PMC10439640 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12909-023-04528-2. | PMC10439640 | ||
Keywords | PMC10439640 | |||
Introduction | Clinical Records (CR) are fundamental to keeping track of patients’ conditions, transmitting essential information among healthcare professionals working on a team and from a legal point of view [In the last few years, online resources opened up many innovative possibilities for teaching, with distance and blended less... | PMC10439640 | ||
Materials and methods | PMC10439640 | |||
Trial design | A multi-method randomised controlled two-arms parallel-groups trial was conducted, wherein the assessors and the statistician were blinded to the groups the students were assigned. This study is reported in line with the Consolidated Standards of Reporting Trials [ | PMC10439640 | ||
Setting and participants | This trial was conducted at the Bachelor of Science (BSc) degree course in ‘Speech Therapy’ at the University of Verona (Verona, Italy). The targeted study population consisted of third- and second-year students who attended the second semester of this three-year course before starting the placement. Participants were ... | PMC10439640 | ||
Interventions | Participants were randomised in a 1:1 ratio into one of the two groups described below. The two groups were composed of students in the second and third years. Group 1 attended an asynchronous course, whereas Group 2 attended a synchronous one. Both courses took place in March 2021. Both classes were held by two speech... | PMC10439640 | ||
Intervention group | The intervention group received an asynchronous course conducted by LD. The asynchronous course was carried out through the use of Google Classroom. The course consisted of four modules with videos that lasted a maximum of 15 min each. The first module presented the course. The second one explained how to write a CR fr... | PMC10439640 | ||
Control group | The control group received a synchronous course conducted by GDB. The synchronous lesson lasted 2 h, was conducted via ‘Zoom’ in March 2021 and consisted of a frontal lecture using slides and a mobile audience response system (i.e., ‘Mentimeter’). The topics covered were the same as those treated in the asynchronous in... | PMC10439640 | ||
Randomisation | An external person to this study generated a random allocation sequence using a computer-generated random number list with simple randomisation ( | PMC10439640 | ||
Outcome | PMC10439640 | |||
Primary outcome – quality of CRs | The primary outcome was the differences between the two groups in the quality of production of a CR that contained the assessment and the treatment of a patient they saw during their placement. A literature search was conducted to look for a checklist to assess CR. Since no checklists were retrieved, an ad hoc checklis... | PMC10439640 | ||
Secondary outcome – students’ experience | Semi-structured interviews were conducted with each student to investigate students’ experience of attending asynchronous or synchronous lectures. The interviews were performed online, by videoconferencing, and they were conducted only with the interviewee. GDB and LD produced and transcribed an audio-visual recording ... | PMC10439640 | ||
Data and statistical analysis | PMC10439640 | |||
Primary outcome (quality of CRs) | Statistical analyses were performed by one researcher (SB) that did not know to which group participants belonged. Descriptive analysis was carried out to describe the participants’ profile, evaluating the homogeneity between the groups’ data and the demographic variables of the sample (age, gender they identified with... | PMC10439640 | ||
Secondary outcome (students’ experience) | Data were analysed following the six steps of the ‘Thematic Analysis’ reported by Braun and Clarke (Table
Steps of the ‘Reflexive Thematic Analysis’The use of thematic analysis in this study was majorly inductive, as we took the dataset as starting point for our data analysis [ | PMC10439640 | ||
Sample size | PMC10439640 | |||
Primary outcome (quality of CRs) | A priori analysis was run to calculate the sample size needed. It was based on G * Power 3.1 application. Based on other studies on online lecturing, an effect size of d = 0.70 was set [ | PMC10439640 | ||
Secondary outcome (students’ experience) | All study participants were interviewed, and their interviews were subsequently analysed chronologically based on the dates they were conducted. The analysis was conducted collaboratively by GDB and LD, who maintained continuous communication to refine the coding process and develop subsequent themes. The analysis of i... | PMC10439640 | ||
Results | A total of 50 students were included in the study (25 in the intervention group and 25 in the control group). The intervention (asynchronous) group was composed of 24 women (96%) and one man (4%) and 12 (48%) students from the second year, and 13 (52%) from the third year. The control (synchronous) group was composed o... | PMC10439640 | ||
Primary outcome (quality of the CRs) | Table
Students’ score30.0[26.0; 32.0]30.0[23.5; 31.5]d = 0.1[-0.6; 0.7]12.0[11.0; 12.0]12.0[11.0; 12.0]d = 0.3[-0.3; 0.8]18.0[15.0; 20.0]18.0[13.0; 19.5]d = 0.2[-0.5; 0.8]Legend: Q1, first quartile; Q3, third quartile | PMC10439640 | ||
Secondary outcome (students’ experience) | INTERACTION | Among the fifty students who were interviewed, only 30 interviews were analysed (15 from the synchronous group and 15 from the asynchronous group). Descriptive data of this subgroup is reported in Table
Demographic characteristics of intervieweesLegend: Async, asynchronous; Sync, synchronous; W, woman; M, manAnalysis ... | PMC10439640 | |
Theme 1: different forms of learning interaction | INTERACTION | The participants shared the advantages of both asynchronous and synchronous teaching modalities, highlighting how each modality facilitated their learning through distinct mechanisms. Therefore, we generated the theme: ‘Different Forms of Learning Interaction’. Participants in the synchronous group reported a positive ... | PMC10439640 | |
Theme 2: different ways to manage the time | ’ | The students reported a common thread in their narration, namely, how they managed their time to deal with their lectures, which differed between the synchronous and asynchronous groups. Hence, we created the theme ‘Different Ways to Manage the Time’. The disadvantage in the synchronous mode was being unable to manage ... | PMC10439640 | |
Theme 3: to be or not to be (present)? | SAID, COLD | The students highlighted the impact of the lecturer’s physical presence (or absence) on their learning experiences. Consequently, we generated the theme: ‘To Be or Not To Be (Present)? In the synchronous group, the students experienced the physical presence of the lecturer positively. They felt it was an advantage as h... | PMC10439640 | |
Theme 4: Inspiring relationships with the peers | doubts | A shared experience among the students, regardless of their respective groups, was the strong bond they formed with their peers. This bond was so impactful that the students preferred engaging with their peers rather than the lecturer, irrespective of the teaching modalities. As a result, we established the theme: ‘Ins... | PMC10439640 | |
Discussion | doubts, anxiety, reduction of social anxiety | This study evaluated the effectiveness of asynchronous and synchronous classes aimed at teaching to speech therapy students how to write a CR during the placement. Moreover, this study explored the students’ experiences of attending those courses. From what was retrieved from this study, it is possible to bring to the ... | PMC10439640 | |
Acknowledgements | DEL | This work was developed within the DINOGMI Department of Excellence framework of MIUR 2018–2022 (Legge 232 del 2016). | PMC10439640 | |
Authors’ contributions | All authors made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data. All authors drafted the work or revised it critically for important intellectual content. All authors approved the version to be published. All authors agree to be accountable for... | PMC10439640 | ||
Funding | This study did not receive any external funding. | PMC10439640 | ||
Data Availability | Data are available upon reasonable request to the corresponding author. | PMC10439640 | ||
Declarations | PMC10439640 | |||
Ethics approval and consent to participate | All methods were performed in accordance with the relevant guidelines and regulations following the Declaration of Helsinki. Ethics approval was obtained from the Ethics Committee of the Department of Human Sciences, University of Verona (17 February 2021, code 2021_04). The participants signed informed consent to part... | PMC10439640 | ||
Consent for publication | The participants signed informed consent for publication before participation. | PMC10439640 | ||
Competing interests | The authors declare no competing interests. | PMC10439640 | ||
List of Abbreviations | Clinical recordConfidence intervalReflexive thematic analysis | PMC10439640 |
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