Randomized Control Trial Design Research Articles

Meta-Analysis: Effect of Acupuncture Therapy in Lowering Frozen Shoulder Pain

Background: Acupuncture therapy has become a popular non-drug therapy with good curative effects, convenient application, non-toxic side effects, and low cost, and it has been widely used in the treatment of Frozen Shoulder. This study aims to analyze and estimate the effect of acupuncture therapy on reducing the degree of pain in Frozen shoulders. Subjects and Method: This study used a systematic review and meta-analysis by following PICO, Population: Frozen Shoulder patients. Intervention: acupuncture therapy. Comparison: no acupuncture therapy. Result: reduction in the degree of Frozen shoulder pain. The data used was obtained from scientific research articles from electronic databases including PubMed, Google Scholar, Hindawi, BMC, Scopus, and Science Direct Randomized Control Trial (RCT) designs from 2011 to 2022 which report effect sizes with mean and SD. The keywords used in the search for scientific articles are “Acupuncture” AND “Frozen Shoulder” AND “Frozen Shoulder Pain”. The selection of articles was carried out using the PRISMA flowchart. Data were analyzed using Review Manager software version 5.4.1. Results: A total of 9 articles with eligible RCT designs from Asia and Europe were selected for the systematic review and meta-analysis. The results of the meta-analysis showed that patients with Frozen Shoulders who received acupuncture therapy experienced a degree of pain 0.48 units lower than without acupuncture and was statistically significant (SMD= -0.48; 95% CI= -1.14 to -0.18; p=0.15). Conclusion: Acupuncture therapy reduces the degree of Frozen Shoulder pain. Keywords: acupuncture, pain, frozen shoulder. Correspondence: Mehdya Vikia Murti. Masters Program in Public Health, Universitas Sebelas Maret. Jl. Ir. Sutami 36A, Surakarta, Central Java 57126. Email: mehdyvikiamurti@gmail.com. Mobile: +62895363037033.

Efficacy of Pilate’s Exercise with Postural Advice in the Management of Low Back Pain for Lower Limb Amputee Patients: A Randomised Control Trial

Objective: To observe the effectiveness of Pilate’s exercise, with postural advice to reduce low back pain for lower limb amputee patients. Material and Methods: An assessor-blind, randomised control trial design has been used wherein sixty-two patients were divided into two groups by simple random allocation. The experimental group received the Pilates’ Training Program with postural advice, and the control group received usual care at the prosthetic department. There were thrity-one participants in both groups that completed the study. Both groups attended a 15-minute specialized, supervised session; 5 days a week, for 4 weeks. Outcomes were measured in terms of pain by a numeric pain rating scale and specific function & disability of the lumbo-pelvic region by the Roland-Morris Low Back Pain and Disability Questionnaire. Descriptive (median and inter quartile range, IQR) and inferential statistics (Pearson Chi-square test, Mann-Whitney U test and Wilcoxon Signed Rank Test) were performed to analyse the data through the Statistical Package for Social Sciences (SPSS), Windows version 25 (IBM, Armonk, NY, USA). Results: Average age of participants was 33 (29.75 to 47.50) years; whereas, the average duration of amputation in the experimental group was 11 (7 to 13) months compared to 8 (6 to 11) months in the control group. Both groups showed significant improvement in terms of pain intensity and functional ability in intergroup analysis (p-value<0.05); additionally, in intra-group analysis participants that received Pilate’s exercise with postural advice had better outcomes than participants who received only postural advice (p-value<0.05). Conclusions: It was concluded that Pilate’s exercise with postural advice is effective in the rehabilitation of patients with lower limb amputee-induced low back pain. Additionally, Pilate’s exercises with postural advice also led to better improvement in mechanical correction of the lumbo pelvic region.

Poster 361: Prolotherapy in the Treatment of Sports-Related Tendinopathies: A Systematic Review

Objectives: Prolotherapy (PrT) involves the injection of a proliferant in order to irritate a microenvironment and promote healing via the inflammatory cascade. PrT has become an increasingly popular nonoperative treatment in orthopedics. However, numerous prolotherapy solutions exist and varying applications and results have been described. The purpose of this study is to review high-quality randomized controlled trials (RCTs) that analyzed efficacy and safety profiles of prolotherapy (PrT) treatments for the most common sports-related tendinopathies. Methods: All RCTs published in English between January 1st 1980 and July 30th 2021, reported in Embase, Medline, and Web of Science databases, were queried with search terms including sclerotherapy, prolotherapy, sports medicine, sports injuries, tendinopathies, and musculoskeletal pain/injuries. PRISMA guidelines were used. Studies analyzing tendinopathies using a RCT design were included, while case controls, reviews, and observational studies were excluded. Duplicates were eliminated through Endnote. The remaining articles were screened by titles, followed by abstract and then by full text analysis. The Cochrane collaboration tool was used to assess for risk of bias. Two researchers independently performed the screening and conflicts were resolved using Rayyan © software (Rayyan Systems Inc., Cambridge, MA, USA). Graphical representations were created using SPSS version 28.00. Results: Application of the inclusion and exclusion criteria yielded 20 RCTs (fig. 1): 6 studies on lateral epicondylitis (LE); 6 on rotator cuff tendinopathy (RC); 5 on plantar fasciitis (PF); 2 on Osgood-Schlatter disease (OSD); 1 on Achilles tendinosis. Most of the trials used dextrose injections over P2G or hypertonic glucose (fig. 2), and the most common studied conditions were LE and RC (fig.3). The average follow-up period was 12 weeks. No significant adverse effects were reported, and the most common outcome measures were visual analog scale (VAS), patient rated tennis elbow evaluation (PRTEE), quick- disabilities of the arm, shoulder, and hand (Q-DASH), and symptoms relief. For the treatment of LE, dextrose PrT was associated with significant improvement in VAS pain score at rest and PRTEE compared to normal saline (p<0.041, p<0.013 respectively). Additionally, compared to hyaluronic acid and lifestyle modifications, PrT showed significant improvement in VAS pain score with activity, Q-DASH, and PRTEE scores (p<0.04, p<0.04, p<0.05 respectively). For the treatment of RC, dextrose PrT was found superior to physiotherapy in the shoulder disability index (p<0.001). Finally, dextrose PrT demonstrated significant improvements in foot function index (p<0.001) for the treatment of PF, and reduction of symptoms in OSD (p<0.024) compared to physical therapy and lidocaine controls. Patients with AT had a more rapid improvement in symptoms in the combined PrT/eccentric loading exercises protocols compared to dextrose PrT alone (p<0.007). A graphical representation of the results is reported in figure 4. Conclusions: This systematic review summarized high quality RCTs and found PrT injections to be overall safe and effective in the treatment of sports-related tendinopathies. Further RCTs with larger sample sizes and comparisons to orthobiologics would add to the literature. Based on the current findings, sports medicine professionals may safely pursue PrT as an additional component of conservative treatment before surgery.

Effect of aerobic and resistance exercise training on anthropometric parameters of human immunodeficiency virus-positive individuals

Background: The use of antiretroviral drugs has made human immunodeficiency virus (HIV)/AIDS a chronic disease with adverse anthropometric changes as one of its complications. Objectives: This study investigated the effects of aerobic and resistance exercise training on anthropometric parameters of HIV-positive individuals. The study examined the influence of aerobic and resistance exercises on body mass index (BMI), waist-to-hip ratio (WHR), percentage body fat and visceral fat of persons living with HIV/AIDS in a tertiary health institution in South–South zone of Nigeria. Methods: A randomised control trial design was employed in this study. Eighty-eight HIV-seropositive patients in stages 1 and 2 participated in the study. Randomisation was done into the control and aerobic exercise group and resistance exercise group. The experimental groups exercised thrice a week for 10 weeks and the non-experimental group received usual antiretroviral drugs and counselling. Initial intensity of the exercise was 60% HRmax and 1-RM and progression was by 10% every 3 weeks. Anthropometric parameters were recorded initially and on termination of 10 weeks for all three groups. Frequency, mean, standard deviation, and analysis of covariance (ANCOVA) were used for the data analysis. The Bonferroni pairwise comparison was used as post hoc test to identify the source of differences. Results: The outcome of this research showed that aerobic and resistance exercises resulted in significant alterations in anthropometric parameters of BMI (f = 13.617; Sig = 0.000), percentage body fat (f = 10.074; Sig = 0.000), WHR (f = 11.070; Sig = 0.000) and visceral fat (f = 10.286; Sig = 0.000). Conclusion: It was, therefore, concluded that aerobic and resistance are beneficial to HIV-seropositive persons and recommended that exercise should be prescribed for HIV-infected persons to enhance their anthropometric parameters resulting in improved health.

Vibrating toothbrush, ice, or topical anesthetic agent to reduce pain of local anesthetic injection in 5- to 12-year-old children undergoing dental procedures — a randomized controlled trial

BackgroundApplication of topical anesthetic agent prior to injection is the most commonly used method to control initial needle penetration pain of local anesthetic injection. Ice and vibration stimulus application are other nonpharmacologic methods used to reduce painful sensations of injection. The present study aims to verify and compare topical anesthetic, ice pretreatment, and electric toothbrush as a vibratory device, to reduce the pain of local anesthetic injections.The study was conducted on children aged 5–12 years, requiring extraction of a maxillary primary tooth. A randomized control trial design was used wherein each child was randomly assigned by permuted block randomization design method to receive either lignocaine 5% as topical anesthetic or ice pretreatment or motorized toothbrush as a vibratory device during local anesthetic injections. Sound, eye, and motor (SEM) scale was used for objective evaluation of pain during injection, and Faces Pain Scale (FPS) was used for subjective evaluation. For statistical analysis, nonparametric test — Kruskal Wallis/ANOVA test for three groups and between two groups Mann–Whitney U-test, was used to compare SEM and FPS values. Level of significance chosen was p < 0.05.ResultsSEM (palatal) and FPS (palatal) scores were slightly higher in topical anesthetic group as compared to ice pretreatment or vibration group, but the differences were not statistically significant. There were no statistically significant differences among SEM (buccal) and FPS (buccal) scores in all the three groups.ConclusionsIce cooling and electric toothbrush-induced vibration were as effective as topical anesthetic for reduction in pain due to injection.Trial registrationThe CTRI number of the trial is CTRI/2021/03/032046.

Implementation and experimental evaluation of school-based intervention programs promoting adolescent mental health: Lessons learned

Targeted school-based programs seem to be a promising approach to help adolescents in need. Nevertheless, successful implementation and evaluation of such programs is challenging. However, there is limited knowledge about (overcoming) the challenges of implementation and experimental evaluation of school-based programs. The goal of the present paper is, therefore, to improve future research by describing the challenges encountered and lessons learned during two randomized controlled trials (RCTs) to study the effectiveness of two skills-training programs reducing school or social stress. In this way, we aim to inform others who plan to implement and evaluate such programs in schools using an RCT design. Some of the challenges encountered apply to all effectiveness studies, such as the recruitment and retention of participants; others are more “intervention at school” specific, such as scheduling the programs and assessments. Our experiences show that it is possible to effectively implement and evaluate targeted programs promoting adolescent mental health in secondary schools with RCTs, even during a worldwide health pandemic, but that it requires investing sufficient time in keeping close and regular contact as well as clear communication between the involved parties. Moreover, high levels of flexibility are needed in adjusting scheduled meetings for intervention and research while keeping track of the entire process for each school and individual participant.

Effect of Supplementary Food Substitution of Sea Urchin Gonads (Diadema Setosum) on TSH Hormone, Height, and Weight of Stunted Toddlers in Soropia District

Stunting results in generational loss due to decreased ability to work productivity and IQ. Thyroid Stimulating Hormone (TSH) plays an important role in the growth process, in chronic growth hormone deficiency conditions will spur the incidence of stunting. The purpose of the study was to determine the effect of supplementary food formula substitution of sea urchin gonads (Diadema Setosum) on Thyroid hormone, height and weight of stunted toddlers in Soropia District. This experiment using RCT (Randomized Control Trial) design. The sample in this study were stunted toddlers in Soropia District. The formula uses a substitution of sea urchin gonads (Diadema Setosum) which is given in one portion of additional food. Additional food in the form of nuggets, sausages, bakwan. The formula is given for 3 months with a frequency of every day for 90 days. The Results to be achieved that the availability of supplementary food formulations substituting sea urchin gonads, nutritional content of supplementary food formulas, energy and protein consumption data, data on body height and thyroid hormone levels, body height and weight before and after supplementary food formulas

Trauma-Informed Care on mental health wards: the impact of Power Threat Meaning Framework Team Formulation and Psychological Stabilisation on self-harm and restrictive interventions.

The aim of this evaluation was to assess the impact of introducing a model of Trauma-Informed Care (TIC), comprising weekly Power Threat Meaning Framework (PTMF) Team Formulation and weekly Psychological Stabilisation staff training, to a National Health Service (NHS) adult acute inpatient mental health unit over a four-year period. A retrospective service evaluation design was employed to assess for differences in the number of incidents of self-harm, seclusion and restraint in the four-year period following the introduction of TIC, when compared to the year prior. Significant reductions were demonstrated in the monthly number of incidents of self-harm (p < 0.01; r = 0.42), seclusion (p < 0.05; r = 0.30) and restraint (p < 0.05; d = 0.55) following the introduction of TIC. Findings suggest that PTMF Team Formulation and Psychological Stabilisation training can contribute to significant reductions in self-harm and restrictive interventions (seclusion and restraint) on adult mental health wards. Qualitative interviews with staff and service users from the unit will support a better understanding of the mechanisms of this change. Further research, employing a randomised control trial design, could increase the validity and generalisability of findings. However, the ethical implications of withholding potentially beneficial practices from a control group would need to be considered.

The role of Improv in enhancement of Meaning in Life in youth: An explanatory sequential design

Abstract“A global mental health crisis” was sparked by the pandemic, especially for the youth as it exposed them to serious existential crises related to grief, loss, death and dying, deep psychological insecurities, etc. Additionally, this crisis came as a call for greater meaning in the personal and professional lives of youth. To deal with these issues in youth, Improv intervention is being used as an effective contemporary psychological technique to improve holistic perspective‐taking. This pilot study investigated the efficacy of Improv intervention in enhancing Meaning in Life in youth using an explanatory sequential design. The sample comprised 80 youth (age range 18–25 years). The study was carried out in two phases—quantitative and qualitative. In the quantitative phase, a randomised control trial design was used to assess the efficacy of the intervention; this was followed by semistructured interviews to identify crucial themes that highlighted participants’ perceptions of Meaning in Life and the benefits of the intervention. Results revealed potential usefulness of Improv in Meaning enhancement.

Intervention Fidelity to VITAL Start (Video Intervention to Inspire Treatment Adherence for Life) in a Randomized Controlled Trial Among Women Living With HIV in Malawi.

Intervention effectiveness in a randomized controlled trial is attributed to intervention fidelity. Measuring fidelity has increasing significance to intervention research and validity. The purpose of this article is to describe a systematic assessment of intervention fidelity for VITAL Start (Video intervention to Inspire Treatment Adherence for Life)-a 27-minute video-based intervention designed to improve antiretroviral therapy adherence among pregnant and breastfeeding women. Research Assistants (RAs) delivered VITAL Start to participants after enrolment. The VITAL Start intervention had three components: a pre-video orientation, video viewing, and post-video counseling. Fidelity assessments using checklists comprised self (RA assessment) and observer (Research Officers, also known as ROs) assessment. Four fidelity domains (adherence, dose, quality of delivery, and participant responsiveness) were evaluated. Score scale ranges were 0 to 29 adherence, 0 to 3 dose, 0 to 48 quality of delivery and 0 to 8 participant responsiveness. Fidelity scores were calculated. Descriptive statistics summarizing the scores were performed. In total, eight RAs delivered 379 VITAL Start sessions to 379 participants. Four ROs observed and assessed 43 (11%) intervention sessions. The mean scores were 28 (SD = 1.3) for adherence, 3 (SD = 0) for dose, 40 (SD = 8.6) for quality of delivery, and 10.4 (SD = 1.3) for participant responsiveness. Overall, the RAs successfully delivered the VITAL Start intervention with high fidelity. Intervention fidelity monitoring should be an important element of randomized control trial design of specific interventions to ensure having reliable study results.

Feasibility of remotely delivered and supported aerobic walking exercise training for cognitive processing speed impairment in fully-ambulatory persons with multiple sclerosis.

The current pilot, single-blind, randomized controlled trial (RCT) examined the feasibility of remotely-delivered and supported aerobic walking exercise training compared with an active control condition on cognitive processing speed (CPS) in 19 fully-ambulatory persons with multiple sclerosis (pwMS) who were pre-screened for impaired CPS. Feasibility was assessed in the domains of process (e.g., recruitment), resource (e.g., monetary costs), management (e.g., time requirements), and scientific outcomes (i.e., treatment effect). Fully-ambulatory, but CPS-impaired pwMS were randomly assigned into either 16-weeks of home-based aerobic walking exercise or home-based stretching and range-of-motion activities. Both conditions involved delivery of informational newsletters and one-on-one, online video chats with a behavior coach. Participants across both conditions tracked their activity using highly accurate wearable motion sensors. Treatment-blinded assessors administered the Symbol Digit Modalities Test (SDMT) remotely before and after the 16-week study period. The study was cost-effective, accessible, and acceptable. The intervention further was safe. Adherence and compliance rates across both conditions exceeded 80%. There was an overall moderate effect for change in SDMT score between the conditions (d=0.42). The intervention was associated with a 4.8-point improvement in SDMT scores (d=0.70; 10% increase) compared with a 1-point improvement for the control condition (d=0.09; 2% increase). This remotely-delivered and supported aerobic walking exercise training intervention was safe and feasible for fully-ambulatory, CPS-impaired pwMS. The pattern of results, including the promising effects on CPS, support the design and implementation of an appropriately-powered RCT on this approach for managing CPS impairment in a large MS sample.

Current practices in studies applying the target trial emulation framework: a protocol for a systematic review

IntroductionObservational studies represent an alternative to estimate real-world causal effects in the absence of available randomised controlled trials (RCTs). Target trial emulation is a framework for the application of RCT...

Induction immunochemotherapy conversion rate and survival outcomes versus chemotherapy in initially unresectable esophageal squamous cell carcinoma.

e16077 Background: Currently, no comparative study has been reported to elucidate whether the addition of immunotherapy in the induction setting could improve treatment efficacy and prolong the overall survival of initially-unresectable locally advanced esophageal squamous cell carcinoma (iuESCC). This study aimed to compare surgical conversion rate and short-term overall survival in induction chemotherapy (iC) and induction immunochemotherapy (iIC) for patients with iuESCC. Methods: In this multicenter retrospective cohort study, patients with the guideline-defined unresectable disease were included at four high-volume institutions. The primary endpoints were conversion surgical rate and overall survival (OS). Pathological complete response (pCR) was defined as the disappearance of tumor cells in the primary lesion site. Multivariate cox regression analysis was used to identify the independent significant prognostic factors associated with OS. The stabilized inverse probability of treatment weighting (IPTW) was applied to confirm the survival comparison between iIC and iC cohorts. Results: A total of 309 patients (150 in iIC and 159 in iC cohort) were included. A significantly higher conversion surgical rate was observed in iIC cohort (iIC vs. iC: 127/150, 84.7% vs. 79/159, 49.7%, P &lt; 0.001). In terms of pathological response, the rates of pCR were 22.0% and 5.1% in the iIC and the iC cohort, respectively (P = 0.001). A significant difference in OS was observed between iIC (not reached) and iC cohorts (median [95% CI]: 36.3 [27.2 – 45.5] months). The stabilized IPTW yielded similar results. Regimen (iIC vs. iC, HR 0.215, 95% CI: 0.102 - 0.454, P &lt; 0.001) and operation (Yes vs. No, HR 0.262, 95% CI: 0.161 - 0.427, P &lt; 0.001) were the significant prognostic factors for OS. Further, subgroup analysis revealed that significantly higher OS was seen in iIC cohort than that in the iC cohort (P = 0.003) in patients who had non-pCR disease. Conclusions: Immunochemotherapy plus conversion surgery in the induction setting had higher pathological response rate and better OS in iuESCC patients. Moreover, this combined modality also contributed to improving OS in patients with residual tumor burden. This study provided evidence for future randomized control trial designs.

Comparison of the Quality of Phase Ⅲ Non-commercial Clinical Trials in Japan, the United States, and the United Kingdom before the Implementation of the New Japanese Clinical Trials Act

Recent research misconduct, represented by the valsartan scandal, has raised questions about the quality of non-commercial trials not for regulatory approval in Japan. Unlike in the US and Europe, non-commercial clinical trials are not regulated by law in Japan, which was believed to be a reason why quality could not be guaranteed. However, until now, few studies have compared the quality of clinical studies among countries. In this study, the quality of Japanese non-commercial phase Ⅲ trials before the implementation of the Clinical Trials Act (CTA) in 2018 was compared with Western non-commercial trials registered in the database using study design as quality indicators. The study found a lower proportion of randomized, controlled trials (RCTs) (70％ in Japan, 89％ in the US, and 88％ in the UK) and fewer blinded designs (46％ in Japan, 59％ in the US, and 52％ in the UK) in non-commercial trials in Japan. Single-arm trials not for either cancer or rare diseases, which are usually considered low quality because of a lack of fair comparison, were more common in Japan (82％) than in the US (76％) and the UK (50％). In terms of endpoint setting, most non-commercial trials in Japan had surrogate endpoints, with only a few trials using true endpoints (5％) compared to the US (24％) and the UK (40％). A comparison of these quality indicators in Japanese non-commercial trials before and after the CTA implementation showed no increases in the proportion of RCT and blinded designs, but an increase in the proportion of trials using true endpoints and appropriate use of single-arm design. In conclusion, the lack of legal regulation in Japan may have indirectly affected the quality of non-commercial phase Ⅲ trials in Japan at the time. Implementation of the CTA has contributed to some quality improvements, but the effect is limited at present.

Generate Analysis-Ready Data for Real-world Evidence: Tutorial for Harnessing Electronic Health Records With Advanced Informatic Technologies.

Although randomized controlled trials (RCTs) are the gold standard for establishing the efficacy and safety of a medical treatment, real-world evidence (RWE) generated from real-world data has been vital in postapproval monitoring and is being promoted for the regulatory process of experimental therapies. An emerging source of real-world data is electronic health records (EHRs), which contain detailed information on patient care in both structured (eg, diagnosis codes) and unstructured (eg, clinical notes and images) forms. Despite the granularity of the data available in EHRs, the critical variables required to reliably assess the relationship between a treatment and clinical outcome are challenging to extract. To address this fundamental challenge and accelerate the reliable use of EHRs for RWE, we introduce an integrated data curation and modeling pipeline consisting of 4 modules that leverage recent advances in natural language processing, computational phenotyping, and causal modeling techniques with noisy data. Module 1 consists of techniques for data harmonization. We use natural language processing to recognize clinical variables from RCT design documents and map the extracted variables to EHR features with description matching and knowledge networks. Module 2 then develops techniques for cohort construction using advanced phenotyping algorithms to both identify patients with diseases of interest and define the treatment arms. Module 3 introduces methods for variable curation, including a list of existing tools to extract baseline variables from different sources (eg, codified, free text, and medical imaging) and end points of various types (eg, death, binary, temporal, and numerical). Finally, module 4 presents validation and robust modeling methods, and we propose a strategy to create gold-standard labels for EHR variables of interest to validate data curation quality and perform subsequent causal modeling for RWE. In addition to the workflow proposed in our pipeline, we also develop a reporting guideline for RWE that covers the necessary information to facilitate transparent reporting and reproducibility of results. Moreover, our pipeline is highly data driven, enhancing study data with a rich variety of publicly available information and knowledge sources. We also showcase our pipeline and provide guidance on the deployment of relevant tools by revisiting the emulation of the Clinical Outcomes of Surgical Therapy Study Group Trial on laparoscopy-assisted colectomy versus open colectomy in patients with early-stage colon cancer. We also draw on existing literature on EHR emulation of RCTs together with our own studies with the Mass General Brigham EHR.

Study protocol for a randomised controlled trial to determine the effectiveness of a mHealth application as a family supportive tool in paediatric otolaryngology perioperative process (TONAPP)

BackgroundOtorhinolaryngology (ORL) surgery is common in children, but hospitalisation, surgery, and home care after discharge are stressful experiences for young patients and their family caregivers. Findings from literature highlight a lack of time in hospitals to support ORL surgery children and their caregivers through the perioperative process, along with the risks of caregivers’ autonomous web or social media resources investigation. Therefore, this study aims to evaluate the effectiveness of a mobile health application with content to support ORL patients and their caregivers in the perioperative period to reduce caregiver anxiety and child distress compared to standard care.MethodsAn open-label, two-arm randomised control trial design is being adopted. The intervention consists of a mobile health application with content to support ORL patients and their caregivers during the perioperative period. One hundred eighty participants will be enrolled and randomly assigned to the experimental group using the mHealth application or the control group. The control group receives standard information and education about the ORL perioperative period from healthcare providers orally or through brochures. The primary outcome is the difference between the intervention and control groups in preoperative caregiver state anxiety. Secondary outcome measures include children’s distress before surgery and family preparation for hospitalisation.DiscussionThe results of this study will be critical to the implementation of a new and safe model for the management of care and education in paediatrics. This model can achieve positive organisational and health outcomes by supporting continuity of care and empowering citizens to have informed participation and satisfaction in paediatric health promotion and management.Trial registrationTrial identifier: NCT05460689 registry name: ClinicalTrials.gov. Date of registration: July 15, 2022. Last update posted: February 23, 2023.

Telenursing Applications in Treatment Compliance among Patients with Mental Disorders

Background: Treatment adherence is one of the problems in the treatment of patients with mental disorders. Telenursing is a part of telemedicine that plays an important role in providing modern nursing care, improving the quality of care, and accessing services quickly. Purpose: To describe the use of telenursing in medication adherence in patients with mental disorders. Methods: Literature review searches were conducted on PubMed, Wiley, and Google scholar. The search strategy used the keywords "telenursing" OR "telehealth" AND Medication Adherence" AND "Mental disorder". The inclusion criteria are the article uses a Randomized Control Trial design, the article does not limit the place or location, published in the last 5 years (2017-2021), in English and free full text. While the exclusion criteria are qualitative research, mixed-method, journal review/systematic review, published under 2017, the title and abstract do not match. Results: Four articles matched the inclusion criteria and topics. From four articles, it was found that the application of telenursing in mental disorders uses TIPS (Telephone Intervention Problem Solving), LEAN (Lay health supporters, E-platform, Award, and iNtegration), cellular applications such as WhatsApp, WeChat, Telegram, Line. Conclusion: With a smartphone application, it can provide a signal, reminder, or education, in overcoming forgetting or not wanting to take medicine or forgetting to control schedules and can be adjusted to resource and geographical conditions. The use of telenursing can help people with mental disorders to increase their belief in the importance of treatment, increase treatment adherence, reduce the length of hospital stay.

Feasibility of a placebo-controlled trial of antibiotics for possible urinary tract infection in care homes: a qualitative interview study.

Diagnosis of suspected urinary tract infection (UTI) in care and nursing home residents is commonly based on vague non-localising symptoms (for example, confusion), potentially leading to inappropriate antibiotic prescription. The safety of withholding antibiotics in such cases could be addressed by a randomised controlled trial (RCT); however, this would require close monitoring of residents, and support from care home staff, clinicians, residents, and families. To explore the views of residential care and nursing home staff (herein referred to as care home staff) and primary care clinicians on the feasibility and design of a potential RCT of antibiotics for suspected UTI in care home residents, with no localising urinary symptoms. A qualitative interview study with primary care clinicians and care home staff in the UK. Semi-structured interviews with 16 care home staff and 11 primary care clinicians were thematically analysed. Participants were broadly supportive of the proposed RCT. The safety of residents was a priority and there was strong support for using the RESTORE2 (Recognise Early Soft Signs, Take Observations, Respond, Escalate) assessment tool to monitor residents; however, there were concerns about associated training requirements, especially for night and temporary staff. Effective communication (with residents, families, and staff) was deemed essential, and carers were confident that residents and families would be supportive of the RCT if the rationale was clearly explained and safety systems were robust. There were mixed views on a placebo-controlled design. The perceived additional burden was seen as a potential barrier, and the use of temporary staff and the out-of-hours period were highlighted as potential risk areas. The support for this potential trial was encouraging. Future development will need to prioritise resident safety (especially in the out-of-hours period), effective communication, and minimising additional burden on staff to optimise recruitment.

The Effect of Structured Antenatal Education on Childbirth Self-Efficacy.

Antenatal (prenatal) education is a vital role of midwives when giving antenatal care to pregnant women. Particularly in the late stages of pregnancy, antenatal education regarding the natural-labor process, the introduction of labor rooms, coping strategies, and labor-pain management may enhance maternal self-efficacy and perceptions of childbirth. However, educational programs that include birth plans, pain-relief measures, and birth preparation are not a structured part of the Saudi healthcare system. This is the first study to investigate the effect of antenatal education on maternal self-efficacy in Saudi Arabia. The aim of this study was to investigate the effect of an antenatal education program on maternal self-efficacy in primiparous pregnant women and to determine the relationship between maternal self-efficacy and their sociodemographic characteristics in Jeddah, Saudi Arabia. A randomized control trial (pretest/posttest) design was conducted with 94 primiparous pregnant women. Two groups were compared: an intervention group, which received a structured antenatal educational program (n = 46), and a control group, which received routine antenatal care (n = 48). The childbirth self-efficacy inventory (CBSEI) was used to assess maternal self-efficacy. The data were analyzed using IBM SPSS Statistics for Windows, Version 24 (Released 2016; IBM Corp., Armonk, New York, United States). The mean score on the CBSEI pretest was 238.5 ± 237.4 compared to 242.9 ± 276.2 in the posttest mean score, with significant differences (p < .05)in maternal self-efficacy between the pretest and posttest scores for both groups. The findings of this study suggest that an antenatal educational program could serve as an essential tool, providing access to high-quality information and skills during the antenatal period and significantly enhancing maternal self-efficacy. It is crucial to invest resources to empower and equip pregnant women in ways that promote positive perceptions andboost their confidence regarding childbirth.

Effect of home-based group conversation intervention using smartphone application on cognitive health and psychological well-being of older adults with subjective cognitive concerns in Japan: a randomized controlled trial protocol.

Social activity is a key component in the prevention of cognitive decline. However, face-to-face social intervention has limited accessibility. To address this issue, we developed the "Photo-Integrated Conversation Moderated by Application" (PICMOA), a home-based group conversation intervention using smartphones. This paper introduces the PICMOA intervention and the protocol of the ongoing randomized controlled trial (RCT), which aims to evaluate the effects of PICMOA on the cognitive functioning and psychological well-being of Japanese community dwelling older adults at the risk of cognitive function decline. This study uses an RCT design in two parallel group trials with 1:1 allocation. The participants are community dwelling older adults aged 65 years and above, living in an urban city in Japan, with subjective cognitive concerns. In total, 81 participants were allocated to the intervention or control groups. The intervention group receives 30 min of weekly PICMOA sessions at their home for 12 weeks. The PICMOA intervention consists of (1) a photo preparation period before the session and (2) a structured group conversation session talking about the photos that participants took according to a specific theme. The control group receives 30 min of weekly health education videos on a tablet device. The primary outcome is cognitive functioning at pre- and post-phases of the 12-week intervention measured using the Telephone Interview for Cognitive Status in Japanese, semantic and phonemic fluency tests, and the Digit Span Forward and Backward tests. The secondary outcomes are psychological and social aspects including mental status, well-being, loneliness, and social support. Interest is growing in internet-based activities for preventing social isolation. However, the effect of remote conversation interventions on cognitive functioning remains unclear. This study addresses this issue and provides a new avenue of social participation for older adults. https://www.umin.ac.jp/ctr/, identifier: UMIN000047247.