Clinical Research Directory

Generative AI Simulated Patients Versus Expert Demonstration Videos for Psychiatric Interview Training in Occupational Therapy Students

The goal of this study is to compare two methods for teaching psychiatric work-history interviewing to third-year occupational therapy students: practice with a generative AI simulated patient and an expert demonstration video. The main questions it aims to answer are: 1. Which teaching method leads to better interview performance in an objective structured clinical examination (OSCE) with a standardized patient? 2. How do the two methods affect students' interview self-efficacy? 3. How do students evaluate the two methods, and which learning sequence do they prefer? Students enrolled in a required vocational rehabilitation course were randomly assigned to one of two sequences. In the first teaching week, one sequence practiced interviewing a GPT-4o-based simulated patient (a 35-year-old person with schizophrenia), and the other watched and discussed an expert demonstration interview of the same case. Both groups completed a 9-minute standardized-patient OSCE on the same day. In the following week, the two sequences crossed over to the other method. Interview self-efficacy was measured before teaching, after the first method, and after the second method.

Fear of Cancer Recurrence Therapy (FORT): Turkish Cultural Adaptation and Implementation Project

This project had two phases. In the first phase, the group-based Fear of Recurrence Therapy (FORT) was culturally adapted for Turkish cancer survivors (Nüks Korkusu Terapisi, NKT) through a four-stage process based on the WHO and ecological validity frameworks: literature review, translation and expert review of the manual, cognitive interviews with survivors and psycho-oncology experts, and an adaptation workshop. In the second phase, a two-arm randomised controlled trial compared NKT with an active CBT-based supportive group in women with stage I-III breast cancer. Both interventions were delivered online in six weekly group sessions. The planned sample was 136 participants (68 per arm); 100 were randomised (50 per arm). Questionnaires were completed at baseline (T0), post-treatment (T1), and 3 (T2) and 6 (T3) months after the final session. The primary outcome was the total score of the Turkish Fear of Cancer Recurrence Inventory at 3 and 6 months; secondary outcomes were intolerance of uncertainty, self-efficacy, quality of life and cancer coping. Analyses were planned as repeated-measures ANCOVA within a general linear modelling framework.

ChangeGradients: Promoting Adolescent Health Behavior Change

As most adolescents visit a healthcare provider once a year, health behavior change interventions linked to clinic-based health information technologies hold significant promise for improving healthcare quality and subsequent behavioral health outcomes for adolescents (Baird, 2014, Harris, 2017). Recognizing the potential to leverage recent advances in machine learning and interactive narrative environments, the investigators are now well positioned to design health behavior change systems that extend the reach of clinicians to realize significant impacts on behavior change for adolescent preventive health. The proposed project centers on the design, development, and evaluation of a clinically-integrated health behavior change system for adolescents. CHANGEGRADIENTS will introduce an innovative reinforcement learning-based feedback loop in which adolescent patients interact with personalized behavior change interactive narratives that are dynamically personalized and realized in a rich narrative-centered virtual environment. CHANGEGRADIENTS will iteratively improve its behavior change models using policy gradient methods for Reinforcement Learning (RL) designed to optimize adolescents' achieved behavior change outcomes. This in turn will enable CHANGEGRADIENTS to generate more effective behavior change narratives, which will then lead to further improved behavior change outcomes. With a focus on risky behaviors and an emphasis on alcohol use, adolescents will interact with CHANGEGRADIENTS to develop an experiential understanding of the dynamics and consequences of their alcohol use decisions. The proposed project holds significant transformative potential for (1) producing theoretical and practical advances in how to realize significant impacts on adolescent health behavior change through novel interactive narrative technologies integrated with policy-based reinforcement learning, (2) devising sample-efficient policy gradient methods for RL that produce personalized behavior change experiences by integrating theoretically based models of health behavior change with data-driven models of interactive narrative generation, and (3) promoting new models for integrating personalized health behavior change technologies into clinical care that extend the effective reach of clinicians.

Student-Centred Simulation-Based Skills Training on Coping Self-Efficacy, Stress, and Anxiety Among Nursing Students in the UAE

This study will examine whether student-centred simulation-based skills training helps undergraduate nursing students in the United Arab Emirates feel more confident in coping with difficult situations and experience less stress and anxiety. Simulation-based training allows students to practice skills through realistic scenarios. The study will compare a group receiving this training with a comparison group, using questionnaires before and after the training to assess changes in confidence in coping, perceived stress, and current anxiety.

The Effect of Pain Management Education Program on Pain Management Self-Efficacy Among Nurses Caring for Palliative Care Patients: A Quasi-Experimental Study

The goal of this quasi-experimental research designed as a single-group pre-test post-test model is to evaluate the effect of an educational intervention aimed at improving the pain management self-efficacy of nurses providing care to palliative patients on their pain management self-efficacy. The main question it aims to answer is "Does pain management training given to nurses caring for palliative patients improve pain management self-efficacy?". The study sample consisted of nurses providing care to palliative patients. Participants will receive training on "Pain Management in Palliative Care Patients" prepared by the researchers. The training will be given online via Zoom by Nurse Beste Aykaç Özbir, one of the researchers. The training will consist of 4 separate 50-minute sessions with 10-minute breaks, totaling 4 hours over one day.

Evaluation of radKIDS 2.0, a Multi-media Training Program for Elementary School Bullying and Abuse Prevention

The goal of this clinical trial is to evaluate an adapted version of the radKIDS® Personal Empowerment and Safety Education Program in randomly assigned 4th grade classrooms. The primary hypothesis is that students in the radKIDS study arm will have significantly higher growth in safety knowledge, safety skill self-efficacy, confidence in help-seeking and in maintaining personal safety, and self-esteem compared to classrooms in the business as usual condition. At the student level, researchers will compare 4th grade students in classrooms randomized to receive the radKIDS program to those in classrooms receiving their regular instruction. Student participants will complete two surveys a few months apart assessing safety knowledge, self-efficacy, and self-esteem. In the radKIDS2.0 arm, students will receive the radKIDS program between the two surveys. In the control arm, students will receive instruction as usual.

An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer

The aim of this study is to evaluate the feasibility and acceptability of conducting a randomized trial of a brief psychoeducational intervention versus enhanced usual care for patients with locally advanced rectal cancer who are initiating neoadjuvant multimodality treatment.

Sleep Better, Live Better Study

The goal of this clinical trial is to determine the effects of a 12-week sleep behavioral program for adults ages 25-65 with poor sleep and elevated cardiometabolic risk. The main questions it aims to answer are: To evaluate the feasibility of recruitment, enrollment, retention, and data collection; program fidelity; and participant engagement with coaching sessions, text messages, and weekly check-ins; and to assess preliminary pre-post program changes in participant self-reported sleep, sleep self-efficacy, action and coping constructs, and Brain Care Score. Participants will: Complete seven structured sleep coaching sessions by telephone; complete a brief weekly check-in questionnaire received by text message; and receive weekly automated one-way text messaging support.

Unidimensional Self-Efficacy Scale for Multiple Sclerosis (USE-MS) Turkish Adaptation

Multiple Sclerosis (MS) is a chronic, inflammatory, demyelinating, autoimmune disease of the central nervous system. Despite functional limitations and unpredictable disease course, individuals with MS are aimed to maintain different levels of independence according to the level of disability. It is aimed to develop interventions that aim to increase self-efficacy levels and participation in daily life in individuals with this diagnosis. The "Unidimensional Self-Efficacy Scale for Multiple Sclerosis (USE-MS)" is a self-efficacy scale developed specifically for individuals with MS and answered based on patient declaration. The aim of this study is to adapt the "USE-MS" scale into Turkish and to establish its validity and reliability.

Talk Parenting Education Program II

The goal of this clinical trial is to learn whether Talk Parenting, a voice-based program delivered through an Amazon Echo Dot (Alexa), can help parents and caregivers of children ages 3-5 years improve challenging bedtime and morning routines. The main questions it aims to answer are: Does using Talk Parenting improve families' bedtime and morning experiences and children's sleep/wake habits? Does using Talk Parenting improve parents' routine-related parenting practices and confidence, strengthen the parent-child relationship, and reduce children's behavior problems and parents' stress? Researchers will compare families who receive Talk Parenting right away to families who wait 6 weeks to receive the program (a waitlist control group receiving usual services during the wait). Participants will: Complete online questionnaires at the start of the study and again about 6 weeks later (and a follow-up questionnaire later in the study). Receive a pre-configured Amazon Echo Dot (to keep) and instructions to use Talk Parenting routines at home, including a bedtime routine, a brief calming routine, and a morning routine (enabled after the first 2 weeks).

CommunityRx-Cardiovascular Disease

The goal of this single arm pre-test post-test design study is to test the impact of providing patients with information about community-based resources to address health-related social needs and cardiometabolic health in rural African American patients. The main question it aims to answer is: • What is the effectiveness of community resource information on patient self-efficacy to use community resources? Participants will be given: * A personalized "HealtheRx" resource with information about community resources related to food, housing, utility support, transportation, and crisis support. The HealtheRx is personalized for patients based on their age and zip code. * Access to a community resource navigator for support with using the HealtheRx upon request * 2 text messages with reminders about the HealtheRx and access to the community resource navigator

Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study

This clinical trial is about prenatal genetic screening. It will test an intervention to help people make decisions about screening. The intervention is a short set of information cards about screening. This intervention is for pregnant participants. They will use the intervention on their mobile phone before they see their doctor. The study has one main question: * Do participants who use the intervention feel more confident when they make a decision about screening? Researchers will compare participants who use the intervention to participants who do not. All participants will have their usual care when they visit their doctor. What will participants do? * Participants must be pregnant. They will sign up for the study before their first doctor's visit for their pregnancy. This is the visit where their doctor usually talks with them about screening. * Some participants will use the intervention before their first doctor's visit. Other participants will not use it. * All participants will talk with a researcher on the phone after their first doctor's visit. * Participants who use the intervention will answer a short survey on their phone. * A few participants who use the intervention will talk with a researcher a second time on the phone.

Nurse-led Integrated Home Service to Support Parents in Symptom Management for Children Requiring Respiratory Support

The aims of this study are to test the effectiveness of a nurse-led integrated home health service to enhance parental self-efficacy in symptom management for children requiring respiratory support, and alongside identify factors facilitating or deterring the program implementation. A single group pre-post quasi-experimental study on parents of CMC requiring respiratory support. Parents will be recruited from non-government organizations, with an estimated sample size of 80 parents. Self-administrated questionnaire, and semi-structured interview guide will be used for data collection.

Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU

Preterm infants, 1 in 12 Canadian births, are at a significant increased risk of poor health outcomes, resulting in high healthcare burden. Parents of these infants report lower self-efficacy and worse mental health when compared to parents of term infants. There is an urgent need to use effective ways to improve parental self-efficacy and associated parent psychosocial and infant health outcomes. To improve parent and baby outcomes, the investigators will build on an existing eHealth solution to create Chez NICU Home+ (CNH+), which offers web-based, parent-targeted, interactive educational tools, virtual communication, and text message support during a baby's NICU stay. We will evaluate whether Chez NICU Home+ improves parental self-efficacy (primary outcome), parent psychosocial, and infant health outcomes in parents of babies requiring a NICU stay, and the implementation (ease and uptake) of Chez NICU Home+ in multiple sites. This study will be a multicentre implementation study, with a stepped wedge cluster randomized controlled trial across four Canadian NICUs. At the beginning of the study, data regarding current care will be collected from all sites to determine a baseline. Following baseline data collection, every five months one of the sites will start using the Chez NICU Home+ solution. A total of 600 parents and their babies, who are expected to stay at least 14 days in the NICU, will be recruited. Parents will complete a survey on psychosocial adjustment and infant outcomes when the study begins, as well as at 14 and 21 days after enrollment, at infant discharge from the NICU, and at 6 months post-discharge. Infant health and development outcomes will be collected at discharge, 6 and 18 months post-discharge via health records. The investigators predict that Chez NICU Home+ will be a positive, interactive care option, combining virtual parent education, tailored communication, and support, which will improve parental self-efficacy and parent psychosocial and infant health outcomes, and have long-term benefits for families.

Effect of Gamified Sun Protection Education Provided to Chemotherapy Patients

Chemotherapy may cause photosensitivity and other skin reactions that can negatively affect patients' comfort, quality of life, and adherence to treatment. Appropriate sun protection behaviors are therefore important for patients receiving chemotherapy. This randomized controlled trial aims to evaluate the effect of gamified sun protection education on sun protection self-efficacy and sun protection behaviors in patients receiving chemotherapy. A total of 54 patients will be randomly assigned to two groups, with 27 participants in each group. Participants in the intervention group will receive gamified sun protection education, while participants in the control group will receive usual care. The educational intervention will be delivered over a two-week period. Sun protection self-efficacy and sun protection behaviors will be assessed at baseline and after completion of the two-week intervention.

The PREGNANT (Pregnant Resident Empowerment, GuidaNce, and Advocacy iN Training) Coaching Project

This is a mixed-methods study designed to develop and evaluate an innovative coaching program for physician trainee mothers. Approximately 48 participants will be recruited from informational flyers posted in resident work areas and distributed by program directors and GME. Interested participants will email study staff. Participants will be randomized to the control or intervention arm. Intervention participants will meet monthly with a novice physician coach of their choice (one-on-one) and a certified physician coach (with an assigned group of 6 peers through video-conferencing). Participants in both arms of the study will respond to surveys at three points: enrollment (baseline), 4 months, and 7 months. At each point, they will spend approximately 10 minutes filling the survey. The survey will query demographics, burnout, professional fulfillment, imposter phenomenon, self-valuation, self-efficacy, resilience, quality of life, and impact of work on professional relationships. The coaching intervention will last 4 months, and the 7 month survey will be used only to assess long-term effects of the intervention. At the conclusion of the study (7 months after enrollment), participants will be interviewed over video communication (secure Partners or Harvard Zoom) for approximately 30 minutes.

Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease

Patients with fibrotic insterstitial lung disease (ILD) participating in inpatient rehabilitation or in outpatient pulmonary care will be invited to participate in this observational study. Patients will fill out questionnaire regarding quality of life and symptoms at baseline and follow-up (at the end of rehabilitation or after the second outpatient ILD consultation). Additionally, clinical data obtained in clinical routine or for the IIP registry will be used for this project. The aim is to assess changes in self-efficacy and quality of life over time and to establish a control cohort for a later feasibility study on a educational and self-management intervention (currently in planning).

Using 360-Degree Interactive Video for Bleeding First Aid in Nursing Education: Effects on Knowledge, Self-Efficacy, and Learning Experience

The goal of this clinical trial is to learn if a 360-degree interactive virtual reality (VR) video simulation works to improve first aid knowledge, knowledge retention, and self-efficacy in stopping severe bleeding among first-year undergraduate nursing students. The main questions the study aims to answer are: * Does experiencing the interactive VR video simulation increase students' knowledge of bleeding first aid? * Does the VR video simulation increase students' long-term retention of first aid knowledge? * Does the VR video simulation improve students' self-efficacy in bleeding first aid? Researchers compared four groups using a Solomon four-group design to evaluate the effectiveness of the VR simulation, while also testing whether taking a pre-test affected the final outcomes. Participants: * Completed an introductory survey and possibly a baseline test measuring first aid knowledge and self-efficacy. * Attended a 1-hour standard classroom lecture about first aid for bleeding. * (Intervention groups only) Completed a 5-minute interactive 360-degree video simulation of a severe bleeding emergency using an Oculus Quest 2 VR headset, which required answering 7 clinical decision-making questions. * Completed follow-up tests 4 weeks and 8 weeks after the training to measure their bleeding first aid knowledge and self-efficacy.

Effectiveness of Dental Health Education Methods on Oral Hygiene, Oral Health Care Self-Efficacy and Self-Esteem of Young Orphans

Background: Orphan children are at higher risk of developing oral diseases, compared to non-orphans. They also face various emotional, social, and psychological distresses which affect their general as well as oral health. Aim: To evaluate the effectiveness of three methods of dental health education; namely peer group and game-based health education methods on oral hygiene behavior, oral health care self- efficacy and self-esteem level of a group of institutionalized orphans in Alexandria, Egypt, as compared to conventional health education. Materials and methods: A three-arm randomized controlled clinical trial was compared between peer group based dental health education, game-based dental health education, and conventional dental health education. The study recruited 264 Orphans from non-governmental orphanages in Alexandria, Egypt. Apparently healthy orphans between 7 and 12 years old whose responsible guardians gave consent to allow them to participate in the study will be included. The primary outcome was the improvement in oral hygiene behavior measured by changes in OHI-S and gingival index and the secondary outcome was the change in orphans' self-esteem measured by the Child version of Rosenberg Self-Esteem Scale and the change in orphans' oral health care self-efficacy measured by oral heath behavior self-efficacy questionnaire.

Understanding the Role of Doulas in Supporting People With PMADs

Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.

Effects of Stoma Education on Patients

tomas are classified according to the anatomical region in which they are created and the surgical technique used. Stomas that open into the large intestine are called colostomies, those that open into the small intestine are called ileostomies, and the creation of an anastomosis of the ureters to the abdominal wall is called a urostomy. Stomas are commonly used in the treatment of gastrointestinal diseases. Ileostomy and colostomy are the most frequently encountered types of stomas. While colorectal cancer is the primary reason for intestinal stoma creation, inflammatory bowel diseases, penetrating abdominal injuries, congenital anomalies, obstructions due to diverticular disease, ischemic colitis, radiation injury, sigmoid colon volvulus, and fecal incontinence are also among the indications for stoma creation. Despite advances in surgical techniques, complications are commonly seen in individuals with stomas. Incorrect stoma placement, the use of inappropriate bags and adapter systems, and a lack of knowledge and skills among patients and caregivers play a significant role in the development of complications. Depending on these conditions, patients may encounter problems such as edema, bleeding, ischemia, and mucocutaneous dehiscence in the early postoperative period. These complications negatively affect not only physical health but also the individual's social life, psychological state, and overall quality of life. Symptoms such as peristomal skin problems, uncontrolled gas release, fecal incontinence, and pain can hinder participants' adaptation to daily life and lead to social isolation. Nursing care and patient education are of great importance in managing these problems faced by individuals with stomas. The nursing process requires a comprehensive approach extending from the pre-operative period to the post-discharge phase. In this process, individualized education programs addressing fundamental issues such as nutrition, elimination, sexuality, social participation, and privacy should be implemented to improve quality of life, develop self-care skills, and prevent complications. In this context, the investigators have planned this study to determine the effects of the education provided to patients on stoma adaptation, body image, and self-efficacy.

The Effect of Scenario-Based Simulation Training for Nutritional Counseling During Pregnancy on Nursing Students' Anxiety Levels, Self-Efficacy Perceptions, and Clinical Skill Performance

The Effect of Scenario-Based Simulation Training for Nutritional Counseling During Pregnancy on Nursing Students' Anxiety Levels, Self-Efficacy Perceptions, and Clinical Skill Performance: A Randomized Controlled Trial Research Hypotheses H1: Scenario-based simulation training significantly reduces anxiety levels among nursing students. H2: Scenario-based simulation training significantly increases nursing students' perceived self-efficacy. H3: Scenario-based simulation training significantly improves nursing students' clinical skill performance. H0₁: Scenario-based simulation training has no statistically significant effect on nursing students' anxiety levels. H0₂: Scenario-based simulation training has no statistically significant effect on nursing students' perceived self-efficacy. H0₃: Scenario-based simulation training has no statistically significant effect on nursing students' clinical skill performance.

Factors Affecting Burnout in Physiotherapists in Turkey

This cross-sectional descriptive study aims to identify the demographic, occupational, organisational and individual psychological factors that predict burnout among physiotherapists working in active clinical practice in Turkey. Using a four-block hierarchical multiple regression approach, the relative contribution of workload and role factors, organisational factors, psychological resilience, self-efficacy and Type A behaviour pattern to the three dimensions of burnout (emotional exhaustion, depersonalisation and personal accomplishment) will be quantified. Turnover intention is examined as a secondary dependent variable. Data are collected through an anonymous online survey distributed nationwide.

Psychoeducational Course for Suicide Prevention

The plan is to include patients with a history of increased risk of suicide. In the aftermath of an episode of imminent suicide risk, patients will receive a psychoeducational course that entails information on different aspects of suicide-related topics, identifying triggers and detecting early warning signals for increased suicide risk. The course culminates in working on completing a individual safety plan to prevent an future increase in suicide risk. The course will incorporate both patients and their next of kin. The psychoeducational course will be compared to a control group where the patients receive one individual session with focus on a safety plan to evaluate the intervention. Both groups will receive treatment as usual (TAU) during both the acute phase and follow-up. The study will be conducted as a randomized controlled trial.