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Acknowledgements | This study was supported by Chang Gung Memorial Hospital (CMRPD1M0042, BMRP553), Healthy Aging Research Center, Chang Gung University from the Featured Areas Research Center Program within the Framework of the Higher Education Sprout Project by the Ministry of Education (MOE) in Taiwan (EMRPD1M0411), National Science and Technology Council in Taiwan (NSTC 111-2314-B-182-037-MY3), and the National Health Research Institutes (NHRI-EX112-11105PI) in Taiwan. | PMC10558527 | ||
Author contributions | Y.W.C. performed the main statistical analysis, interpreted the data and wrote the first draft of the manuscript. K.Y.L. contributed to development of intervention protocol and data analysis. P.H.H. contributed to project management, data collection and preliminary data analysis. C.H.L. and H.T.L. assisted in data collection and intervention protocols. C.Y.W. contributed to development of the study protocol, grant application, project management and revision of manuscript. All authors made editorial contributions to the manuscript. All authors read and approved the final manuscript. | PMC10558527 | ||
Data availability | The datasets used and/or analyzed during the current study are not publicly available due to the confidentiality issue but are available from the corresponding author upon reasonable request. | PMC10558527 | ||
Competing interests | The authors declare no competing interests. | PMC10558527 | ||
References | PMC10558527 | |||
Background: | PRESSURE INJURY | 3M microfoam™ surgical tape (3ST: 3M Japan Limited) is used for pressure wound control of medical equipment. It is cushioned and can be fitted to any body part. Here we investigated whether 3ST prevents nasal pressure injury associated with nasotracheal intubation (NTI). | PMC9839254 | |
Methods: | We conducted a prospective, randomized double-blind study, enrolling 63 patients aged 20 to 70 years, who underwent general anesthesia with NTI. They were divided into 2 groups; those treated with 3ST (group | PMC9839254 | ||
Results: | PRESSURE INJURY | Nasal pressure injury was observed in 7 and 19 patients from groups | PMC9839254 | |
Conclusion: | PRESSURE INJURY | 3ST prevents nasal pressure injury associated with NTI. | PMC9839254 | |
1. Introduction | NASAL BLEEDING, PRESSURE ULCER, PRESSURE INJURY, PRESSURE INJURY, COMPLICATIONS | Nasotracheal intubation (NTI) is frequently necessary during dental and oral maxillofacial surgeries, specifically during operations with operative field and airway converge. However, some complications associated with NTI such as nasal bleeding,The National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, and Pan-Pacific Pressure Injury Alliance collectively published It is reported that the application of hydrocolloid dressing to the nasal alar is effective in preventing nasal pressure injury associated with NTI.Hoshijima et al state that the meta-analysis of nasal protection strategy suggests that the use of a nasal protection strategy considerably reduces the risk of a nasal pressure injury during NTI; however, the number of samples in the meta-analysis was too small for trial sequential analysis, thus further research is needed. | PMC9839254 | |
2. Materials and methods | PMC9839254 | |||
2.1. Ethics approval and consent to participate | This study was conducted in accordance with the ethical standards of the Declaration of Helsinki (1964) and its subsequent amendments. Moreover, this study adhered to the Consolidated Standards of Reporting Trials guidelines (CONSORT) and was approved by the Ethics Committee at the School of Dentistry, Aichi Gakuin University (Approval No. 637). Furthermore, written informed consent was obtained from all patients participating in the trial, and before patient enrollment, the trial was registered as a clinical trial at UMIN-CTR (Registration No. UMIN000045524, Date of first registration: 21/09/2021). The first patient was recruited and registered on September 27 | PMC9839254 | ||
2.2. Study design and population | skin irritation | CONSTRICTION, RECRUITMENT | We conducted a prospective, randomized double-blind study with a blinded evaluator and patients, enrolling 63 patients aged 20 to 70 years and scheduled to undergo general anesthesia with NTI for oral and maxillofacial surgery. Exclusion criteria were those withan obvious nostril constriction (n = 0) and deformities inside the nostrils (n = 0) observed during preoperative CT test taken prior to the surgery, previous surgery around the nostrils (n = 0), and those prone to skin irritation (n = 0). Among the recruited patients, those who did not provide consent (n = 1) were excluded from the study. Therefore, the final study population included 62 patients who were randomly divided into 2 groups, namely the group treated with 3ST (group CONSORT flowchart describing patient recruitment. | PMC9839254 |
2.3. Anesthesia and intubation methods | The same method of anesthesia was employed for all patients. The standard vital signs monitors (electrocardiogram, blood pressure, and oxygen saturation) were inspected. Anesthesia was induced using propofol (3 Protection method of nasal wing. Group | PMC9839254 | ||
2.4. Measurements | PRESSURE ULCER, PRESSURE INJURY | The primary outcome was the presence or absence of nasal pressure injury observed from the nasal tip to the nasal alar. After extubation, an assessment was performed by the operating room nurse, who was not informed whether the patient belonged to group Furthermore, we compared the price of 3ST used in this study and the hydrocolloid dressing that can currently be used for pressure ulcer prevention in Japan. | PMC9839254 | |
2.5. Statistical analysis | We estimated that a minimum sample of 56 patients would be needed, where the threshold response, Since the use of statistical tests in the absence of reliable sample size calculation decreases its weightage, we calculated our final sample size considering an expected dropout rate of 0.05 based on our pilot study. Hence, if a dropout rate (R) is expected, a simple but adequate adjustment is provided by NFor statistical testing, the Chi-square test of independence was used to test the relationship between 2 categorical variables, and the Mann–Whitney | PMC9839254 | ||
3. Results | PMC9839254 | |||
3.1. Patients’ background | Sixty-three patients were selected to participate in this study from September 2021 to November 2021. The participant CONSORT flow diagram is presented in Figure Patient demographic information.Values are in numbers or median (quartiles 1–3). | PMC9839254 | ||
3.2. Presence or absence of nasal pressure injury | PRESSURE INJURY | As depicted in Table Distribution of the patients based on nasal pressure injury associated with nasotracheal intubation.Values are in numbers. | PMC9839254 | |
3.3. Comparison of the price of the surgical tape and hydrocolloid formulation | Table Comparison of the surgical tape prices and hydrocolloid formulation (1 USD = 115 yen). | PMC9839254 | ||
4. Discussion and conclusion | ischemia | ISCHEMIA, PRESSURE INJURY | In this study, on using 3ST for preventing nasal pressure injury associated with NTI, we observed a significant difference in the frequency of nasal pressure injury from the nasal tip to the nasal alar between the groups. Generally, nasal pressure injury during NTI is caused by local ischemia between the nasal columella and alar because of the continuous pressure exerted by the tracheal tube. Moreover, nasotracheal tubes are closely associated with medical device-related pressure injuries.In previous studies on the use of hydrocolloid dressing for the prevention of nasal pressure injury associated with NTI, the preventive effect ranged from 56.7% to 95%.3ST is a multidirectional, stretchable, and thick dressing. It is conformable and adheres gently yet securely to uneven surfaces. Moreover, it is water resistant, free of natural rubber latex, and hypoallergenic foam-based elastic tape. However, as 3ST has strong adhesiveness, the possibility of the adhesive substance getting on the skin cannot be denied. Nevertheless, it is considered a suitable tape for pressure and dressing fixation.As shown in Table Other risk factors for nasal pressure injury during NTI included gender, prolonged operating time, and long intensive care unit stay.This study has several limitations. First, several anesthesiologists were involved in the tape fixation in both groups. Although the tape fixation methods were standardized to the maximum possible extent before initiating the study, individual differences were undeniable. Second, several healthy young patients participated in this study, and we do not know whether the results of this study apply to all age groups. Finally, this study is not a direct comparison between 3ST and hydrocolloid dressing. Future comparative studies between 3ST and hydrocolloid dressing are warranted. In conclusion, 3ST prevents nasal pressure injury associated with NTI. In addition, using 3ST is less expensive than hydrocolloid dressing. | PMC9839254 |
Acknowledgements | The authors would like to thank Enago ( | PMC9839254 | ||
Abbreviations: | Hashimoto | HASHIMOTO, PRESSURE INJURY | 3m microfoam™ surgical tapenasotracheal intubationThe datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.Trial Registration: UMIN-CTR (Registration No. UMIN000045524, date of first registration: 21/09/2021).This study was conducted in accordance with the ethical standards of the Declaration of Helsinki (1964) and its subsequent amendments. Moreover, this study adhered to the Consolidated Standards of Reporting Trials guidelines (CONSORT) and was approved by the Ethics Committee at the School of Dentistry, Aichi Gakuin University (Approval No. 637). Written informed consent was obtained from all patients participating in the trial. Before patient enrollment, the trial was registered as a clinical trial at UMIN-CTR (Registration No. UMIN000045524, Date of first registration: 21/09/2021). The first patient was recruited and registered on September 27th, 2021.The authors report no involvement in the research by the sponsor that could have influenced the outcome of this work.The authors have no conflicts of interest to disclose.How to cite this article: Hashimoto M, Sato (Boku) A, Sento Y, Kamimura Y, Kako E, Okuda M, Tachi N, Okumura Y, Kuroda I, Hoshijima H, Ito H, Sobue K. 3M microfoam™ surgical tape prevents nasal pressure injury associated with nasotracheal intubation: A randomized double-blind trial. | PMC9839254 |
References | PMC9839254 | |||
Abstract | These authors contribute equally to this work. | PMC10798291 | ||
Background | pruritus, postoperative nausea and vomiting | Butorphanol has been used to reduce the incidence and severity of neuraxial morphine-induced pruritus. Palonosetron is a commonly used antiemetic for the prevention of postoperative nausea and vomiting. The aim of our study was to compare the effective dose in 50% of subjects (ED50) of intravenous butorphanol infusion with or without a single intravenous bolus of palonosetron for preventing pruritus induced by epidural administration of morphine. | PMC10798291 | |
Methods | pruritus, NRS | GROUP B | A total of 120 parturients were randomly assigned to receive an intravenous bolus injection of palonosetron plus continuous infusion of butorphanol (Group P + B) or an intravenous bolus of saline plus continuous infusion of butorphanol (Group B) after epidural administration of morphine. The antipruritic effect was graded as satisfactory (numerical rating scale (NRS) of pruritus ≤3) or unsatisfactory (NRS >3) within 48 h after morphine treatment. The first patient in each group received butorphanol infusion at a rate of 4 µg/kg/h. The infusion dose for each subsequent patient in the corresponding group was increased by 0.2 µg/kg/h after an unsatisfactory response or decreased by 0.2 µg/kg/h after a satisfactory response. The ED50 was calculated for each group and compared using up-down sequential analysis. | PMC10798291 |
Results | pruritus | GROUP B | The ED50 (mean [95% confidence interval (CI)]) of the dose of intravenous butorphanol infusion for preventing moderate to severe pruritus was lower in Group P + B (3.29 µg/kg/min [3.25–3.34 µg/kg/min]) than in Group B (3.57 µg/kg/min [3.47–3.67 µg/kg/min]) ( | PMC10798291 |
Conclusions | Under the conditions of the present study, a prophylactic use of 0.25 mg palonosetron reduced the ED50 of prophylactic infusion of butorphanol by approximately 8% to achieve a satisfactory antipruritic effect after epidural morphine for post-caesarean analgesia. | PMC10798291 | ||
Keywords | PMC10798291 | |||
Introduction | Neuraxial administration of morphine, a hydrophilic μ-opioid receptor agonist with well-established effectiveness and a long duration of action, is one of the most effective methods for post-caesarean analgesia [ | PMC10798291 | ||
Materials and methods | PMC10798291 | |||
Design and study subjects | This prospective, double-blinded, randomized dose–response clinical trial was approved by the Research Ethics Committee of Women’s Hospital, School of Medicine, Zhejiang University (Number: IRB-20210132-R). Written informed consent was obtained from all parturients. The trial was registered at the Chinese Clinical Trial Registry (ChiCTR) ( | PMC10798291 | ||
Study protocol | Bradycardia, nausea, ’, Postoperative pain, pain, pruritus, NRS pain, hypotension, Hypotension, height of sensory block | HYPERTENSION, GROUP B | Based on a computer-generated random number sheet, patients were randomly allocated into Group B (intravenous administration of normal saline plus continuous intravenous pump of butorphanol) or Group P + B (intravenous administration of palonosetron plus continuous intravenous pump of butorphanol). An investigator (Hui Wu) who did not participate in any anaesthetic care or data collection opened the sealed envelopes, which contain the group assignments, and prepared the drug according to the group allocation.All patients fasted for over 6 h and received no premedication. On arrival in the operating room, basic vital sings, including pulse oximetry, non-invasive blood pressure, and electrocardiogram were continuously monitored. After a brief settling period, baseline resting BP of the patient will be recorded by calculating the mean of three consecutive measurements with a difference of not more than 10%. Combined spinal-epidural anaesthesia procedure was performed in the left lateral position of patient. First, under local anaesthesia, epidural puncture was performed at the estimated L3-4 vertebral interspace with a 16-G needle, the arrival of the needle tip into the epidural space was identified by the method of ‘loss of resistance to air’. Second, spinal puncture was conducted with a 27-G pencil-tip needle. After ascertaining free flow of clear cerebrospinal fluid from the pencil-tip needle, 15 mg of hyperbaric ropivacaine diluted with 10% dextrose was slowly injected over 15 s. If there is no outflow of CSF from the spinal needle, it will be removed, the direction of the epidural needle will be adjusted and the spinal needle will be reinserted. If there is still no CSF outflow, both needles will be removed and the CSE procedure will be repeated. If the second attempt is also unsuccessful, the case will be withdrawn from the study and further clinical care will be at the discretion of the attending anaesthesiologist. At the same time of ropivacaine injection, 5 mL/kg of warmed lactated Ringer’s solution was infused for 20 min and then slowed down to maintain the patency of veins. Simultaneously, phenylephrine (0.5 µg/kg/min) was given intravenously to prevent hypotension. An epidural catheter was placed into the epidural space cephalally for 3–4 cm. The patients were then returned to the supine position with left uterine displacement. The height of sensory block was evaluated by assessing the loss of anterior midline needling sensation. Surgery was permitted to start when sensory block height reached higher than T6. Hypotension, defined as systolic blood pressure < 90 mmHg or a drop in systolic blood pressure by more than 20% from baseline, was treated with a 50 μg bolus of intravenous phenylephrine. Reactive hypertension, defined as an increase in systolic blood pressure by over 20% from baseline, was treated by immediately stopping the infusion of phenylephrine. Bradycardia (heart rate <50 beats/min) without hypotension was managed by stopping the infusion of phenylephrine, which was restarted when the heart rate increased back to over 50 beats/min. Bradycardia with hypotension was treated with an intravenous injection of 0.5 mg atropine. If nausea occurred during the operation, dexamethasone 5 mg was given intravenously.At skin closure, 2 mg of morphine (diluted to a total volume of 2 mL), followed by a 1 mL normal saline flush, was injected At each time point (6 h, 12 h, 24 h, 48 h) after epidural morphine injection, the severity and location of pruritus and pain were recorded. Postoperative pain was evaluated by NRS pain score (a 10 cm linear scale, with 0 and 10 labelled as ‘no pain’ and ‘worst pain imaginable’, respectively) [ | PMC10798291 |
Statistical analysis | The sample size of the current study was based on the method of up-down allocation [To estimate ED50 and its confidence interval and compare the ED50 value between the two groups, we used RStudio (version 4.2.1) with the package of ed50simulation (version:0.1.1) based on the method described by Dixon-Mood [ | PMC10798291 | ||
Discussion | nausea, nausea and dizziness, vomiting, constipation, dizziness, pruritus, neuraxial morphine-induced, nausea,, urinary retention | ADVERSE REACTIONS | This prospective, double-blinded, randomized dose–response trial is the first study focusing on the infusion dose of butorphanol for preventing morphine-induced pruritus in women having elective caesarean delivery. Our results showed that prophylactic administration of 0.25 mg palonosetron significantly decreases the required dose of butorphanol, reduces the severity of pruritus at 6h after epidural morphine administration, and lowers the incidence of post-operative nausea and dizziness. Butorphanol is considered an appropriate prophylactic measure against neuraxial morphine-induced pruritus. However, high doses of butorphanol can cause adverse reactions such as dizziness, drowsiness, nausea and vomiting, which might limit its clinical use [Although the effectiveness of epidural morphine for post-caesarean analgesia has been well established, morphine can produce undesired side effects, including pruritus, nausea, vomiting, urinary retention, and constipation [Continuous infusion was chosen as the route of butorphanol administration due to its short duration of action. We chose palonosetron for its high affinity for the 5-HT3 receptor and longer plasma half-life (approximately 40h) than other antagonists, such as ondansetron (approximately 3.8 h) [For the regimen and dose of neuraxial morphine, all the participants in this study received 2 mg epidural morphine. The dosage was set based on the protocol in similar studies and our routine clinical experience in practice. Epidural morphine is usually administered at a dose of 1 mg to 3 mg, which is approximately 10 times that in other studies using intrathecal morphine [Our study has some limitations. First, the dose of palonosetron used in the P + B group was fixed at 0.25 mg. Different doses of palonosetron might have different impacts on the ED50 of butorphanol. Second, our study compared the ED50 value for butorphanol infusions. However, in clinical practice, ED90 or ED95 is more preferable. Third, the study only consisted of parturients, the results may be different in other populations. To increase generalizability of the current findings, further studies are needed to focus on the dosage of palonosetron and butorphanol in preventing pruritus induced by epidural neuraxial administration of morphine in other patient populations. | PMC10798291 |
Conclusions | In summary, under the conditions of this study, prophylactic use of 0.25 mg palonosetron reduced the ED50 of butorphanol infusion by approximately 8% to achieve a satisfactory antipruritic effect after epidural administration of morphine in healthy parturients. | PMC10798291 | ||
Ethics approval and informed consent | This randomised, double-blinded study was approved by the Ethical Committee of Women’s Hospital, Zhejiang University School of Medicine (Hangzhou, China) (Approval No. IRB-20210132-R), and was registered prior to patient enrolment at the Chinese Clinical Trials (Registration No. ChiCTR2200055313, | PMC10798291 | ||
Consent for publication | All authors have read and approved the manuscript, and agree to submit to the journal. | PMC10798291 | ||
Authors’ contributions | CCJ | Conceptualization: LHS, LJ; Data curation: LYW, QX; Formal analysis: HW; participants enrolling: CCJ; Drafting of manuscript: LHS, LJ; Revision of manuscript: XZC; Final approval: LHS, LJ, XZC. Funding acquisition: LHS, XZC. All authors agreed to be accountable for all aspects of the work. | PMC10798291 | |
Disclosure statement | No potential conflict of interest was reported by the author(s). | PMC10798291 | ||
Data availability statement | The data supporting the study findings are available from the corresponding author upon reasonable request. | PMC10798291 | ||
References | PMC10798291 | |||
Methods | SECONDARY | We randomly assigned healthy volunteers to undergo a determined skin cleansing protocol for total hip arthroplasty in the supine position to either a colored or colorless skin cleansing protocol. The adequacy of skin preparation was compared between orthopedic consultants and residents. The colorless disinfectant was mixed with a fluorescent dye and missed skin areas were visualized using UV lamps. Both preparations were photo-documented following standardized protocols. The primary outcome of interest was the number of legs with an incomplete scrubbed area. The secondary outcome was the cumulative skin area not disinfected. | PMC9980739 | |
Results | Fifty-two healthy volunteers (104 legs; 52 colored and 52 colorless) underwent surgical skin preparation. The number of legs incompletely disinfected was significantly higher in colorless compared to colored disinfectant group (38.5% (n = 20) vs. 13.5% (n = 7); p = 0.007). Regardless of the disinfectant, consultants performed better than the residents. When using colored disinfectant, residents incompletely prepared the site in 23.1% (n = 6) compared with 57.7% (n = 15) with a colorless disinfectant (p = 0.023). Conversely consultants using colored disinfectant incompletely prepared the site in 3.8% (n = 1) compared with 19.2% (n = 5) for colorless disinfectant (p = 0.191). The total amount of uncleansed skin was significantly higher using colorless skin disinfectant (mean ± standard deviation: 8.78 cm | PMC9980739 | ||
Conclusions | hip arthroplasty | Application of colorless skin disinfectants for hip arthroplasty cleansing protocol led to decreased skin coverage among consultants and residents compared to colored preparations. Colored disinfectants remain the gold standard in hip surgery, however we should be aiming to develop newer colored disinfectants with long residual antimicrobial effects to enable visual control during the scrubbing process. | PMC9980739 | |
Data Availability | All relevant data are within the paper and its | PMC9980739 | ||
Introduction | SSI | SURGICAL SITE INFECTION | Surgical site infections (SSI) can occur from 30 days postoperatively to within 1 year post surgery, if implants are used [ | PMC9980739 |
Objectives | THA | SKIN | We conducted an experimental study comparing the skin coverage with a colored and a colorless preparation following a standardized protocol in simulated total hip arthroplasty (THA) cases. Skin disinfection for THA in the supine position can be challenging due to the large and complex surgical field with some skin areas often being out of direct sight. Furthermore, we investigated the effect of the surgeons’ clinical experience level on the disinfection quality. Our hypothesis was that the use of colorless disinfectants leads to incomplete skin coverage of the scrubbing area and that the surgeon’s experience may also play a role. | PMC9980739 |
Materials and methods | RECRUITMENT | We conducted this randomized controlled clinical, single-centre trial between March and September 2021 at the Hannover Medical School (MHH). No changes to the methods were made after trial start. The local ethical committee approved the study (Nr.: 9579_BO_S_2021), and written informed consent was obtained from all healthy volunteers participating in the study before recruitment. The manuscript follows the CONSORT guidelines for reporting parallel group randomized trials and corresponds to the CONSORT checklist [ | PMC9980739 | |
Participants | Volunteers were recruited during clinical contact and in the context of student teaching. The key inclusion criteria were healthy adults aged between 18 and 65 years old with a body mass index of under 30 kg/m | PMC9980739 | ||
Randomization and cleansing protocol | An orthopaedic resident or an orthopaedic consultant were randomly assigned in a 1:1 ratio. They were randomly asked to scrub the right or left leg of the volunteer and to start with a colored or colorless antiseptic, as shown in the chart ( | PMC9980739 | ||
Randomization and treatment regime used in our study. | A commercially available alcohol + PVP-I–based skin disinfectant (Braunoderm®, B. Braun, Melsungen, Germany) was used as a colored disinfectant, and Schülke-Optics (Schülke & Mayr, Norderstedt, Germany) was used as a colorless solution. Schülke-Optics contains among other ingredients IPA and is used for training and for review because it can be visualized using an UV lamp under darkened conditions ( | PMC9980739 | ||
The leg was divided into 17 zones as demonstrated on the two images to the left: 1) thigh ventral, 2) thigh lateral, 3) thigh dorsal, 4) thigh medial, 5) knee ventral, 6) knee lateral, 7) knee dorsal, 8) knee medial, 9) lower leg ventral, 10) lower leg lateral, 11) lower leg dorsal, 12) lower leg medial, 13) foot ventral, 14) foot lateral, 15) foot plantar, 16) foot medial, 17) heel. | STERILE | The two images on the right show the appearance of the skin preparation under the UV light.The cleansing procedure started ventral. The sequence was: 1) the ventral thigh, 2) the lateral thigh, 3) the dorsal thigh, and 4) the medial thigh. The same sequence was performed for the zones around the knee, lower leg and foot. For the foot, the heel was considered to be an additional zone. The leg was held at the heel/ lower leg by a second person and the investigator switched sides during cleansing protocol. The surgeons were directly informed before the intervention, which disinfectant and which side they had to start with. No sterile drapes were used. | PMC9980739 | |
Outcomes | SECONDARY | The primary outcome of interest was the number of legs with an incomplete scrubbed area.An incomplete skin cleansing area was defined as any visibly not disinfected skin part regardless of size. The secondary outcome was the cumulative size of these areas measured in square centimeters. | PMC9980739 | |
Assessment | Following skin disinfection, a fixed sequence of photographs was performed for documentation purposes. These photographs were systematically reviewed by an independent investigator and missed skin areas were documented, lined out and the area was measured in square centimeters.For this we used the “CAD-KAS Bild-Vermessen 1.0 software (CAD-KAS Kassler Computersoftware GbR, Markranstädt, Germany, UID: DE202044533) ( | PMC9980739 | ||
Figure demonstrating the areas missed and marked out through the use of the CAD-KAS system. | PMC9980739 | |||
Statistical analysis | Continuous variables were checked for normal distribution using the Shapiro–Wilk test, and are presented as mean ± standard deviation (SD). Categorical variables were described as frequencies with percentages. The primary data analyses followed the intention-to-treat principle, in which data from all participants were analysed in the group to which the participants were randomly assigned, regardless received intervention [ | PMC9980739 | ||
Results | The members of the two study groups were all medical students. They were similar with respect to demographic characteristics such as: age, weight and height. The ratio of women to men was 1:1. The overall percentage of uncleansed skin areas was significantly higher in the colorless disinfectant group compared with the colored disinfectant group (38.5% vs. 13.5%; p = 0.007) ( | PMC9980739 | ||
Graph combining the resident and consultant skin preparation completeness based on the number of legs found to have been disinfected fully. | When comparing the use of colored and colorless disinfectants between consultants there was no statistically significant difference. In 26 legs disinfected by consultants using colored antiseptics, only one leg was partially disinfected (3.8%). In 26 legs disinfected by consultants using colorless antiseptics, five legs were disinfected partially (19.2%) p-value = 0.191 ( | PMC9980739 | ||
Comparison between consultant and resident THA skin preparation when using colored vs. colorless skin antiseptic. | When comparing the use of colored and colorless disinfectants between residents there was a statistically significant difference. In 26 legs disinfected by residents using colored antiseptics, six legs were disinfected partially (23.1%). In 26 legs disinfected by residents using colorless antiseptics, 15 legs were disinfected partially (57.7%) p-value = 0.023 (We assumed the human body surface as being 1.8m | PMC9980739 | ||
Graph demonstrating the difference in surface area of inadequately prepared skin (Colored antiseptic v.s. colorless antiseptic). | Dividing this data by the level of seniority of surgeon (consultant vs. resident) showed that the area of uncleansed skin was significantly smaller when prepped by a consultant.The total amount of uncleansed skin in square centimeters by residents using colorless vs. colored skin disinfectant was 16.10±47.89 vs. 1.29±3.68, (p = 0.006). In contrast, the total amount of uncleansed skin in square centimeters by consultants using colorless vs. colored skin disinfectant was 0.84±1.92 vs. 0.01±0.07 (p = 0.072).The forgotten skin areas were more often located outside the field of view of the surgeon. This data was not statistically significant; however, we can infer from this that attention must be paid to the dorsal portion of the leg ( | PMC9980739 | ||
Outcome data. | PMC9980739 | |||
Discussion | THA | SKIN LAXITY, SITE INFECTION, BLIND | We hypothesized that the visualization of skin antiseptics is an important factor in orthopaedic joint surgery. Surgical skin preparation of a complete leg in THA is more challenging than for example abdominal/spinal surgery because the areas are much larger, three-dimensional and sometimes outside one’s own field of view, we were able to demonstrate the following in our study:Using colored antiseptic disinfection in THA (supine) leads more often to complete skin coverage, than colorless, as demonstrated by overall adequacy of skin preparation (overall view: 13.5% vs. 38.5%. level of significance: p = 0.007).The combination of resident orthopedic surgeons and use of colorless antiseptic agent provided the highest rate of incomplete skin preparation. It is often common practice that the resident starts with the preoperative skin preparation, before the consultant joins for the surgical part.There is no control function by the operating theatre staff when using uncolored disinfectants.Even when incomplete skin areas appeared after skin preparation, the size was significantly smaller when using the colored antiseptic agent.Most of the time uncleansed skin areas were outside the surgeon view, like dorsal lower leg. So at least one additional person in the operating room should always observe the disinfection process.One limitation of this study was our inability to blind the surgeons or the examiners of the photo documentation regarding which antiseptic agent used, as colored vs. colorless skin preparation was easy to distinguish between. Furthermore, another limitation of our study was the lack of heterogeneity in our study group. Most participants were young and healthy and as a consequence the composition of their body and skin (e.g., skin laxity) may well be different in our elderly population. We attempted to minimized the impact of this limitation through not telling study participants what the aims of the study were.The study strength is that for the first time, the actual skin coverage of colorless antiseptic agent, in supine THA protocol could be visualized, by using UV—light.Several studies have investigated different skin disinfectants with respect to the risk of subsequent SSI. PVP-iodine (in aqueous solution) alone is clearly inferior to reduce surgical site infections, which has been shown in various studies and meta-analysis (14, 18). Although there is some evidence that CHX + alcohol is superior to PVP-I + alcohol, proof in orthopedic hip surgery is still pending [ | PMC9980739 |
Conclusions | We conclude that colored disinfectants remain the gold standard for skin preparation in hip surgery. The aim should be to use available, clearly visible, colored, alcohol-based disinfectants that also have residual antibacterial effect (e.g., due to addition of CHX [ | PMC9980739 | ||
Supporting information | PMC9980739 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (PDF)Click here for additional data file.(XLSX)Click here for additional data file. | PMC9980739 | ||
References | PMC9980739 | |||
Objective: | knee arthroplasty, TKA | To evaluate the efficacy and safety of perioperative cryotherapy combined with intra-articular injection of tranexamic acid (TXA) in total knee arthroplasty (TKA) and explore a new strategy of enhanced recovery after TKA. | PMC10662860 | |
Methods: | blood loss, postoperative pain | BLOOD LOSS, GROUP B, COMPLICATIONS | We randomly divided 200 patients into 4 groups: normal saline (10 mL) by drainage (Group A, placebo); intra-articular injection of TXA (1 g, 10 mL, Group B); normal saline (10 mL) and continuous cryotherapy postoperatively (Group C) and intra-articular injection of TXA (1 g, 10 mL) and continuous cryotherapy postoperatively (Group D). Primary outcomes were blood loss volume, postoperative pain and circumference variation. We also recorded consumption of analgesics, postoperative length of stay (p-LOS), range of motion (ROM), function score (Hospital for Special Surgery) and severe complications. | PMC10662860 |
Results: | blood loss | BLOOD LOSS | There were statistically significant differences in postoperative drainage volume, total blood loss, hidden blood loss, and visual analogue scale at rest and walking on postoperative day 1 (POD1), POD2, POD3, ROM (POD3, 7, discharge, postoperative month), circumference variation (POD3, 7), p-LOS, Hospital for Special Surgery score (discharge) and drop of hemoglobin on POD3 ( | PMC10662860 |
Conclusion: | blood loss, postoperative swelling, pain | BLOOD LOSS, COMPLICATIONS | Continuous cryotherapy combined with intra-articular injection of TXA provides short-term advantages in reducing blood loss, pain, postoperative swelling, p-LOS and increasing ROM and joint function in the early postoperative period after TKA without increasing any severe complications. | PMC10662860 |
1. Introduction | knee arthroplasty, end-stage knee osteoarthritis, blood loss, TKA | BLOOD LOSS, COLD | Total knee arthroplasty (TKA) is recognized as an excellent surgical procedure for patients with end-stage knee osteoarthritis.Intravenous tranexamic acid (TXA) has been shown that can significantly reduce blood loss in total hip and knee arthroplasty.There are several other strategies to reduce BLV during perioperative period, such as cryotherapy, draining clamping and different knee position.However, there are few reports of cryotherapy combined with TXA in TKA, especially continuous cryotherapy. Considering literature reports on the related effects of TXA and cold therapy, it is necessary to explore the synergistic effect of combined application. In this study, our aim is to evaluate the efficacy and safety of continuous cryotherapy combined with TXA in the perioperative period of TKA and explore a new strategy of enhanced recovery after TKA. | PMC10662860 |
2. Materials and methods | heart disease, phlebitis, osteoarthritis, allergy, anemia, vascular lesion, DVT, systemic rheumatic diseases, coagulopathy, liver/kidney failure, diabetes | RHEUMATOID ARTHRITIS, PULMONARY EMBOLISM, RECRUITMENT, GROUP B, HEART DISEASE, PHLEBITIS, OSTEOARTHRITIS, ALLERGY, SYSTEMIC LUPUS ERYTHEMATOSUS, DVT, ANEMIA, COAGULOPATHY, COLD, ANKYLOSING SPONDYLITIS, DIABETES | This prospective, double-blind, randomized, controlled study was conducted from February 2017 to July 2022. Recruitment was approved by the institutional review board and registered at the Chinese Clinical Trial Registry (ChiCTR2300071161). All patients provided written informed consent before participation. Inclusion criteria were unilateral TKA for osteoarthritis and a signed informed consent form. Exclusion criteria were as follows: allergy for TXA and cold; age ≤ 50 years or ≥80 years; active phlebitis and diabetes with vascular lesion; glucocorticoid use within 3 months or any strong opioids and anticoagulants within a week; history of severe heart disease (NYHA > 2), liver/kidney failure, or systemic rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus); DVT, pulmonary embolism, and coagulopathy before surgery; prior ipsilateral knee surgery; lack of cognitive function or normal sensation; preoperative anemia; and loss to follow-up.The 200 patients were randomly divided into 4 groups (A, B, C, and D), each with 50 patients. All patients were randomly assigned sequences hidden in opaque, sealed envelopes that were opened before surgery. All patients receive intravenous TXA (1 g, 100 mL normal saline, NS) 30 minutes before releasing tourniquet and the drainage was clamped for the first 4 hours after operation. Patients in Group A received an intra-articular injection of NS (10 mL) by drainage and then clamped. Patients in Group B received an intra-articular injection of TXA (1 g, 10 mL NS) by drainage and then clamped. Patients in Group C received an intra-articular injection of NS (10 mL) by drainage and then clamped and continuous cryotherapy postoperatively. Patients in Group D received an intra-articular injection of TXA (1 g, 10 mL NS) by drainage and then clamped and continuous cryotherapy postoperatively. The continuous cold flow device adopted was Evercryo (China). Cryotherapy continues to perform 90 minutes per 120 minutes until 7 days after surgery and ice was changed in the canisters every 4 hours by the nursing staff. All participants, surgeons, anesthesiologists, nurses, and research assistants were blinded to group allocation. | PMC10662860 |
2.1. Patient demographics | knee arthroplasty, DVT | DVT | From February 2017 to July 2022, 240 patients scheduled to undergo primary unilateral TKA were screened for inclusion in the study. Twenty-eight patients did not meet the inclusion criteria, and twelve patients were lost to follow-up at the 3-month endpoint, leading to 200 participants (Fig. Demographic data of the patients receiving TKA.APTT = activated partial thromboplastin time, BMI = body mass index, Hb = hemoglobin, HSS = Hospital for Special Surgery, PT = postoperative prothrombin, TKA = total knee arthroplasty, VAS = visual analogue scale.Schematic diagram of the patient study process.All surgeries were performed by a senior physician of the surgical team in a hundred-level laminar flow operating room. Patients were evaluated by an anesthesiologist and given intraspinal anesthesia in the supine position, middle approach, and bone cement prosthesis (posterior stabilized; DePuy). DVT was detected by lower extremity doppler ultrasound in all patients before discharge. | PMC10662860 |
2.2. Postoperative management | pain | Ankle dorsal, plantar flexion, and quadriceps strength exercises began in the recovery bay. These 4 regions would receive rivaroxaban (10 mg) orally when the drainage was removed at the first 48 postoperative hours. Patients received standard supervised physiotherapy daily, including continuous passive motion, strength training, and walking. After returning to the ward, pain was assessed using a visual analog scale (VAS; 0: no pain, 10: the worst pain imaginable). If VAS scores were between 4 and 6, oxycodone was administered orally at Q8h (10 mg). If pain VAS exceeded 6, 40 mg of Parecoxib (Pfizer, NY) was administered intravenously. The transfusion protocol trigger, according to the agreement which is provided by National Health Commission of People’s Republic of China, was <70 g/L measured at 24 and 72 hours postoperatively. | PMC10662860 | |
2.3. Outcome assessment | blood loss, SSI, cold injury, DVT | BLOOD LOSS, SURGICAL SITE INFECTION, PERIOPERATIVE COMPLICATION, INTRAOPERATIVE BLOOD LOSS, DVT | Intraoperative blood loss, postoperative drainage volume (PDV), VAS at rest and walking on postoperative day 1 (POD1), POD2, POD3, ROM (POD3, 7, discharge, postoperative month), circumference variation (POD3, 7), postoperative length of stay (p-LOS), function score (Hospital for Special Surgery [HSS], discharge) and drop of Hb on POD3 were recorded. Total number and dose of oxycodone, postoperative prothrombin, activated partial thromboplastin time, and perioperative complications (surgical site infection [SSI], DVT, cold injury) were also noted. The total blood loss (TBL) and hidden blood loss (HBL) were calculated by the methods of Nadler. | PMC10662860 |
2.4. Statistical analysis | Statistical analyses were performed in SPSS version 24 (SPSS Inc., Chicago, IL). Data are presented as means ± standard deviation (continuous variables) or raw numbers (qualitative variables). One-way ANOVA and Tukey’s post hoc test were used to evaluate parametric data, while the Mann–Whitney | PMC10662860 | ||
3. Results | PMC10662860 | |||
3.1. Primary outcomes | PMC10662860 | |||
3.1.1. Blood loss volume. | blood loss, intraoperative blood loss | BLOOD LOSS, GROUP B, INTRAOPERATIVE BLOOD LOSS | The PDV, TBL, HBL in Groups B (453.60 ± 52.84; 949.06 ± 224.94; 307.60 ± 83.34), C (437.50 ± 54.38; 851.40 ± 104.71; 274.06 ± 56.12), and D (313.76 ± 60.3; 689.96 ± 100.40; 208.86 ± 67.89) were generally lower than those in Group A (636.60 ± 99.13; 1075.68 ± 212.59; 363.02 ± 93.98) (The comparison of blood loss among the 4 groups. The one-way ANOVA of variance was performed to detect the difference among the groups (*The drop of Hb on POD3 in Group B (28.94 ± 6.66), C (27.56 ± 5.12), and D (24.52 ± 5.01) were generally lower than that in Group A (32.20 ± 3.11) (The comparison of drop of Hb on POD3 among the 4 groups. The one-way ANOVA was performed to detect the difference between the groups (*There was no statistically significant difference among the 4 groups in intraoperative blood loss ( | PMC10662860 |
3.1.2. Pain. | pain | GROUP B | On POD1, 2 and 3, pain scores at rest were significantly lower for Group B (4.44 ± 0.58; 3.02 ± 0.71; 1.86 ± 0.67), C (3.32 ± 0.84; 1.82 ± 0.69; 0.96 ± 0.70), and D (3.28 ± 0.81; 1.74 ± 0.57; 0.80 ± 0.54) than for Group A (5.58 ± 0.61; 4.24 ± 0.70; 4.44 ± 0.58) (The comparison of VAS of pain at rest among the 4 groups on POD 1, 2, and 3. The one-way ANOVA was performed to detect the difference among the groups (*Consistent with pain scores at rest on POD1, 2 and 3, dynamic pain scores on POD1, 2, and 3 were significantly lower for Group B (6.60 ± 0.61; 5.02 ± 0.69; 3.96 ± 0.70), C (5.48 ± 0.89; 3.86 ± 0.73; 3.02 ± 0.65), and D (5.42 ± 0.84; 3.78 ± 0.62; 2.86 ± 0.50) than for Group A (7.70 ± 0.54; 6.24 ± 0.74; 4.52 ± 0.58) (The comparison of VAS of pain at walking among the 4 groups on POD 1, 2, and 3. The one-way ANOVA was performed to detect the difference among the groups (* | PMC10662860 |
3.1.3. Joint swelling. | Circumference variation on POD3 and 7 were significantly lower for Group C (2.82 ± 0.44; 1.44 ± 0.46) and D (2.70 ± 0.27; 1.49 ± 0.36) than for Group A (4.25 ± 0.42; 4.01 ± 0.30) and B (4.23 ± 0.40; 3.90 ± 0.40) (The clinical effect among the 4 groups.HSS = Hospital for Special Surgery, POD = postoperative day, P-LOS = postoperative length of stay. | PMC10662860 | ||
3.2. Secondary outcomes | PMC10662860 | |||
3.2.1. Range of motion. | ROM on POD3, 7, discharge and 1M were significantly greater for Group C (55.34 ± 6.35; 76.74 ± 8.47; 98.22 ± 6.95; 116.54 ± 4.54) and D (55.36 ± 3.98; 75.40 ± 6.42; 98.00 ± 5.36; 116.10 ± 4.73) than for Group A (49.40 ± 4.14; 66.50 ± 3.35; 88.18 ± 3.85; 109.14 ± 2.41) and B (50.84 ± 4.44; 67.82 ± 2.88; 89.08 ± 2.95; 109.40 ± 2.93) (The comparison of ROM among the 4 groups on POD 3, 7, discharge and 1M. The one-way ANOVA was performed to detect the difference among the groups (* | PMC10662860 | ||
3.2.2. Postoperative length of stay and knee function. | GROUP B | P-LOS were significantly less for Group B (12.08 ± 1.41), C (10.76 ± 1.17), and D (10.46 ± 1.53) than for Group A (12.90 ± 1.33) (HSS score at discharge were significantly higher for Group C (86.58 ± 4.70) and D (85.94 ± 3.86) than for Group A (79.98 ± 4.48) and B (80.40 ± 3.21) ( | PMC10662860 | |
3.2.3. Oxycodone consumption, coagulation function and complications. | postoperative coagulation, DVT | DEEP VENOUS THROMBOSIS, SURGICAL SITE INFECTION, COMPLICATION, COMPLICATIONS, DVT | There was no statistically significant difference in total number and dose of oxycodone for Group A (36/50; 730 mg), B (37/50; 580), C (33/50; 530) and D (34/50; 560) among the 4 groups (The postoperative coagulation and complications.APTT = activated partial thromboplastin time, DVT = deep venous thrombosis, PT = postoperative prothrombin, SSI = surgical site infection.The complication rate of DVT for Group A, B, C and D was 1/50, 2/50, 2/50 and 1/50, and there was no statistically significant difference (χ | PMC10662860 |
4. Discussion | swelling, blood loss, DVT, pain, TKA | BLOOD LOSS, COLD, COMPLICATIONS, DVT | Cryotherapy, also known as cold therapy, as an age-old treatment method on acute soft tissue injury, is gradually applied to TKA postoperative rehabilitation, which is also utilized to enhance recovery and outcomes after TKA.How to further reduce perioperative blood loss of TKA is the point we have been working on. TXA has been well documented in reducing blood loss, whether intravenously, topically, or orally,Perioperative pain and joint swelling of TKA, which have been affecting patients’ satisfaction, were also the primary outcomes of this study. Some studies have proved that cryotherapy can reduce perioperative joint pain, swelling, improve ROM and shorten p-LOS. In an earlier prospective randomized controlled study, Sadoghi et alFor new cryotherapy combined with intra-articular injection of TXA, it is generally believed that the incidence of complications is more concern. In this study, the incidence of DVT in Group A, B, C and D was 1/50, 2/50, 2/50 and 1/50, and there was no significant difference in the incidence of perioperative DVT among the 4 groups (This study had some limitations. Firstly, 3 months of follow-up might have concealed different long-term safety profiles in our study. Secondly, the small sample and single center study may weaken the convincing power of our study. Thirdly, this study cannot confirm whether continuous cold flow device is superior to traditional cryotherapy, which is what we need to work on next. Fourthly, single and small doses of TXA may have attenuated the anti-inflammatory effect, and we may try multiple and large doses for further confirmation. Fifthly, we explored the effect of continue cryotherapy combined with TXA without involving clear temperature and suitable dose of TXA for the best effect, and our further study might perform several studies to explore the effect of different temperatures combined with different doses of TXA. | PMC10662860 |
5. Conclusion | blood loss, postoperative swelling, pain | BLOOD LOSS, COMPLICATIONS | Continuous cryotherapy combined with intra-articular injection of TXA provides short-term advantages in reducing blood loss, pain, postoperative swelling, p-LOS and increasing ROM and joint function in the early postoperative period after TKA without increasing any severe complications. | PMC10662860 |
Abbreviation: | knee arthroplasty | blood loss volumedeep venous thrombosishemoglobinhidden blood lossHospital for Special Surgerynormal salinepostoperative drainage volumepostoperative length of staypostoperative dayrange of motionsurgical site infectiontotal blood losstotal knee arthroplastytranexamic acidvisual analogue scaleXH and FL contributed equally to this work.Clinical trial was registered in the Chinese Clinical Trial Registry (ChiCTR2300071161).This research was supported by Research Project of Guangxi Health Commission (Z20170346 and Z2016597), Science and Technology Plan Project of Guangxi (AB16380230), and Research and Development Project of Suitable Medical Technology of Guangxi (S201544).This study was approved by the Medical Ethics Committee (the Ethics Approval acceptance numbe:KY-ZC-2017-01) and an informed consent was obtained from our responsible Investigational Ethics Review Board.The authors have no conflicts of interest to disclose.The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.How to cite this article: Huang X, Li F, Shi W, Liu W, Huang W, Yin D. Efficacy of perioperative cryotherapy combined with intra-articular injection of tranexamic acid in total knee arthroplasty. Medicine 2023;102:29(e34381). | PMC10662860 | |
References | PMC10662860 | |||
Objectives: | disability, Low back pain | CHRONIC LOW BACK PAIN | Low back pain is the leading cause of years lived with disability with a large impact on quality of life and resistance to a broad array of current treatments. This study aimed to investigate the effect of a novel self-administered behavioral therapy-based virtual reality (VR) application on the quality of life of patients with nonspecific chronic low back pain (CLBP). | PMC10205123 |
Methods: | depression, anxiety, pain | ADVERSE EVENTS | A pilot randomized controlled trial was conducted in adults with nonspecific CLBP with moderate to severe pain, waiting for treatment in a teaching hospital-based pain clinic. The intervention group used a self-administered behavioral therapy-based VR application for at least 10 minutes daily for 4 weeks. The control group received standard care. The primary outcome was quality of life at 4 weeks measured by the short form-12 physical and mental scores. Secondary outcomes were daily worst and least pain, pain coping strategies, activities of daily living, positive health, anxiety, and depression. Discontinuation of therapy and adverse events were analyzed as well. | PMC10205123 |
Results: | pain | Forty-one patients were included. One patient withdrew due to personal reasons. No significant treatment effect was found for the short form-12 physical score (mean difference: 2.6 points; 95% CI: −5.60 to 0.48) and mental score (−1.75; −6.04 to 2.53) at 4 weeks. There was a significant treatment effect for daily “worst pain score” ( | PMC10205123 | |
Discussion: | pain | Four weeks of self-administered VR for CLBP does not improve quality of life, however, it may positively affect daily pain experience. | PMC10205123 | |
Key Words: | PMC10205123 | |||
INTRODUCTION | pain, disability, anxiety, Low back pain | DISORDERS | Low back pain is the leading cause of years lived with disability, accounting for over 10% of total years lived with disability.Treatment for CLBP consists mainly of physiotherapy and analgesics, in particular nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids.The use of a behavioral therapy-based virtual reality (VR) intervention might provide therapists and physicians with the means to seamlessly incorporate the psychosocial aspects of pain into the treatment. VR consists of a head-mounted device immersing the user in a 3-dimensional virtual world, which can be used to distract patients from experiencing pain and anxiety and to treat psychological disorders. | PMC10205123 |
METHODS | PMC10205123 | |||
Design | coronavirus disease | This was a pilot open-label randomized controlled trial conducted during the coronavirus disease (COVID) pandemic between January 2020 and January 2021 at Rijnstate Hospital, Arnhem, the Netherlands. The results of the qualitative part of this study have been reported earlier. | PMC10205123 | |
Participants | delirium, anxiety, epilepsy, Meticillin-resistant Staphylococcus aureus, dementia, pain, hearing/visual impairment, depression, Chronic pain | RECRUITMENT, EPILEPSY | The study population comprised patients of 18 years and older with nonspecific CLBP reporting an average pain score of 4 and higher on an 11-point Likert scale in the week preceding enrollment. Chronic pain was defined as pain lasting for at least 3 months. Other inclusion criteria were: (1) the patient has an estimated waiting period of at least 6 weeks on the day of recruitment on the waiting list; (2) the patient is not yet receiving treatment, apart from analgesics or physiotherapy; (3) the patient did not receive any invasive treatment for his chronic nonspecific low-back pain in the last year; (4) patients read and understand the Dutch language. Exclusion criteria were: (1) the patient has radicular pain that is worse than the CLBP; (2) inclusion in another trial to evaluate new ways of treating pain; (3) the presence of severe anxiety or depression; (4) not being able to handle VR due to delirium, dementia, epilepsy, severe hearing/visual impairment, skin of the head or face not intact, and high risk of Meticillin-resistant Staphylococcus aureus. Patients were recruited from a waiting list for advanced pain treatment in a pain clinic of a large teaching hospital. No sample size calculation was performed for this pilot study, but we considered 20 in each group to be sufficient for our primary study aims to investigate the preliminary effectiveness of VR on health-related quality of life in this population. | PMC10205123 |
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