Clinical Research Directory

AI Ambient Scribe in Psychiatry

The goal of this clinical trial is to learn if an artificial intelligence (AI) tool that listens to appointments and drafts clinical notes can help clinicians in psychiatric care. Researchers also want to know if the tool changes how patients experience their care. The study includes mental health care providers (physicians, psychologists/psychotherapists, nurses, and social workers) at Psychiatrie St. Gallen and the adult patients they see in their appointments. The main questions it aims to answer are: * Does the AI tool lower the time clinicians spend writing notes? * Are notes written with the AI tool as good as or better than notes written without it? * Do patients notice a difference in their relationship with their clinician when the tool is used? Researchers will compare clinicians who use the AI tool to clinicians who keep writing notes their usual way, before and during the intervention period, to see if writing time, note quality, and the patient-rated therapeutic relationship differ between the two groups. Clinicians will: Join one of two groups. One group starts using the AI tool on August 17, 2026 (7 clinicians whose devices were delivered late start on November 9, 2026). The other group keeps writing notes the usual way. Both groups will be observed until the end of November 2026 (the 7 late-starting clinicians and additional control data collection until February 22, 2027), with note quality evaluation in February and March 2027. Clinicians who cannot contribute to all measurements may, with their consent, remain in the study for automated measurement of documentation time only. Patients will: \- Be invited to fill out a short, anonymous survey about their experience with their clinician.

Empathy and Communication Training Program for Psychiatric Nurse Specialists in Saudi Arabia (ECTP)

This study tests whether a five-day Empathy and Communication Training Program (ECTP) helps psychiatric nurse specialists in Saudi Arabia engage better with their patients. Good relationships between nurses and patients are central to mental health care, but structured training in empathy and communication is limited in Saudi psychiatric hospitals. The ECTP is a face-to-face program of five two-hour sessions (10 hours in total). It covers empathy and communication, the work environment, language and cultural barriers, and emotional preparedness. Sessions use short lectures, role-play, case discussions and group reflection. The study took place at two psychiatric hospitals. Nurses at the Eradah Complex for Mental Health in Dammam took the ECTP. Nurses at the Eradah Hospital for Mental Health in Madinah attended their usual hospital training sessions instead. Participants were not randomly assigned. The hospital they worked in decided which group they joined. Nurses at both hospitals completed a 15-item questionnaire about therapeutic engagement before and after the training period. After the program, 15 nurses from the Dammam group were interviewed about how the training affected their work and what barriers remained. The study aims to find out whether nurses' self-reported therapeutic engagement improves after the ECTP compared with usual training, and to understand nurses' own experiences of the program.

Psychosocial Effects of Empathy-Based Midwifery Education on Midwifery Students and Pregnant Women

This two-stage quasi-experimental study will evaluate the effects of empathy-based midwifery education on midwifery students' empathy and anxiety, and on women's satisfaction with childbirth and perceptions of traumatic birth. In the first stage, third-year midwifery students in the intervention group will receive four face-to-face training sessions over two weeks, totaling 390 minutes. The program will include theoretical instruction, case discussions, role-play, virtual reality activities, mannequin-based simulation, and guided reflection. Students in the control group will continue their usual coursework and clinical practice. Students' empathy and anxiety will be assessed before and after the training. In the second stage, trained students will provide empathetic communication and psychosocial support to women during labor under the supervision of a faculty member and/or the responsible midwife. Support will include active listening, clear information, reassurance, respect for privacy, and assistance with coping during labor. Women in the control group will receive routine maternity care. Maternal satisfaction with childbirth and perceptions of traumatic birth will be assessed after birth, once the mother and newborn are clinically stable. The study will examine whether this educational program improves students' empathy, reduces their anxiety, and contributes to more positive childbirth experiences for women.

The Effect of Creative Drama on the Therapeutic Communication Skills and Empathy Levels of Pediatric Nursing Students: A Randomized Controlled Study

2.040 This study aims to evaluate the effectiveness of creative drama workshops on the therapeutic communication skills and empathy levels of nursing students. Therapeutic communication is a fundamental skill-particularly in pediatric nursing-for establishing trusting relationships with children and their families and for enhancing the quality of care; however, existing literature indicates that nursing students often lack the desired level of proficiency in this area and that traditional teaching methods may be insufficient for developing these skills. Furthermore, it is reported that empathy development is frequently addressed primarily at a theoretical level, with limited opportunities for experiential learning. In this context, experiential learning approaches, such as creative drama, are considered potentially effective for improving therapeutic communication and empathy skills. The study employs a randomized controlled experimental design. The study population consists of third-year nursing students; based on a power analysis, a total of 52 students (26 in the experimental group and 26 in the control group) are planned to be included. Participants will be assigned to the experimental and control groups via randomization. The experimental group will participate in creative drama workshops once a week for four weeks, while the control group will receive no intervention. Data collection will utilize a Personal Information Form, the Therapeutic Communication Skills Scale for Nursing Students, and the Jefferson Scale of Empathy for Nursing Students. A pre-test/post-test design will be used, and the data will be analyzed using the IBM SPSS 31.0 software program. Statistical analyses will evaluate descriptive statistics, parametric and non-parametric tests, as well as group, time, and group-by-time interaction effects. This study is expected to provide evidence regarding experiential learning-based educational approaches aimed at developing therapeutic communication and empathy skills among nursing students and to contribute to the improvement of nursing education programs.

Mobilization of Emotions and Empathy During Communication Training in Nursing Students

Effective communication in healthcare is vital for patient satisfaction, safety, outcomes, and ethical practice, supporting shared decision-making and informed consent. Simulation-based training is widely used to strengthen communication skills and foster empathy through emotionally engaging experiences. This is a pilot study aimed (1) to assess changes in emotional state and empathy in nursing students after a simulation-based workshop (SBW) on delivering bad news, and (2) to evaluate the sensitivity of standardized scales in detecting these changes.

Strengthening Relationships and Mental Health Through a Couples-Based Economic Empowerment Intervention

This psychosocial sub-study is embedded within a larger cluster-randomised controlled trial titled Disentangling and Preventing Economic Violence against Women (ECOVI), conducted in rural and urban communities across Maharashtra, Andhra Pradesh, and Rajasthan, India. The sub-study evaluates the effects of a couples-based financial-literacy and gender-transformative intervention on psychological distress and relationship quality among married couples. A total of 150 clusters were randomised in a 1:1 ratio to the intervention or control condition by an external trial statistician. Approximately 15 husband-wife pairs were enrolled per cluster, resulting in 2,276 couples at baseline. Participants in intervention clusters attend six structured, community-based sessions that combine financial literacy content with gender equity, communication, empathy, and shared decision-making activities. Participants in control clusters receive no structured study intervention. Assessments are conducted at baseline, before the first intervention session, and at endline, approximately 6 months after intervention delivery. The primary outcome is psychological distress at endline, measured using a response-adapted 6-item General Health Questionnaire. The secondary outcome is relationship quality at endline, measured using a composite of relationship satisfaction and relationship empathy. Treatment effects will be estimated using models that adjust for the corresponding baseline outcome and state. Exploratory mediation analyses will assess whether the intervention's effect on psychological distress is statistically consistent with indirect pathways operating through relationship quality and economic stress.

Sensory Restriction Simulation Training for Nursing Student Empathy and Communication

This study evaluates the effect of the Reality-Integrated Quality Education (GENE) approach, an educational intervention using sensory restriction simulations (vision, hearing, speech, and movement restriction), on empathy, communication skills, patience, psychological resilience, and patient-centered care competency among third-year nursing students. Sixty nursing students will be randomly allocated to an experimental group (n=30), who will complete a single 30-45 minute GENE simulation session, or a control group (n=30), who will receive standard theoretical empathy education without the simulation component. Outcomes will be assessed immediately before and after the session using the Turkish versions of the Jefferson Scale of Empathy - Nursing Student (JSE-NS), a Communication Skills Inventory, a Patience Scale, the Brief Resilience Scale, and a Patient-Centered Care Competency Scale. The investigators hypothesize that participation in the GENE sensory restriction simulations will produce greater short-term gains in empathy, communication, patience, resilience, and patient-centered care competency than theoretical education alone.

Earth of Joy_10477M

Study to evaluate the effect of the Terre de Joie educational kit on children's well-being and empathy at school

Substance Use Treatment and Its Role in Supporting Social Cognition

This study aims to assess changes in empathy levels before and after residential treatment among individuals with substance use disorders.

The COMET Study: a Prospective COhort of MEdical residenTs to Assess Professional, Personal and Psychological Trajectories of Residents in General Internal Medicine

Introduction. Switzerland, like most Western countries, faces a paradox: an ageing, multimorbid population needs general internal medicine (GIM) physicians more than ever, yet fewer young doctors choose - and stay in - the specialty. Career decisions during residency are intertwined with well-being, mental and physical health, and work-life balance, and distress in training has been associated with depression, burnout, attrition and poorer patient care. Longitudinal data following GIM residents across these domains, and linking them to actual career trajectories, are lacking. The COMET study establishes a multicentre prospective cohort of GIM residents to fill this gap. Methods and analysis. COMET is a prospective, open, multicentre cohort conducted in the departments of (general) internal medicine of Fribourg Hospital (HFR, four sites), Bern University Hospital (Inselspital) and Lausanne University Hospital (CHUV). All GIM residents providing direct patient care are eligible (≈334 residents; expected enrolment ≥267, assuming 80% participation). Participants complete an annual online survey (REDCap; French or German) at baseline and for at least four years, covering sociodemographics; job characteristics; career intentions and 24 factors for or against a GIM career; well-being (Physician Well-Being Index, Professional Fulfillment Index, quality of life, work-life balance); mental health (CES-D, Perceived Stress Scale, Maslach Burnout Inventory, Questionnaire of Cognitive and Affective Empathy); and physical health (step counts, physical activity, fatigue, sleep, healthcare utilisation). Primary endpoints are the longitudinal course of well-being and distress (PWBI, PFI, CES-D) and residents' career trajectory. Analyses combine descriptive statistics, mixed-effects and regression models, and comparisons with the population-based CoLaus\|PsyCoLaus cohort.

Facial Affect Sensitivity Training for Young Children With Callous-unemotional Traits

The goal of this study is to test a novel intervention for children ages 6-11 with elevated callous-unemotional (CU) traits. Conduct problems are among the most prevalent and costly mental health conditions of childhood, and a common antecedent to adult psychiatric disorders. An established risk factor for early, persistent, and severe youth misconduct is the presence of CU traits. CU traits (e.g., lack of empathy or guilt, shallow affect) are analogous to the core affective features of adult psychopathy, interfere with child socialization, and predict poorer outcomes, even with well-established treatments for disruptive behavior disorders. Thus, novel intervention approaches are needed to target CU traits. Youth with elevated CU traits show deficits in facial emotion recognition (FER) for distress-related expressions, particularly fear or sadness. The central hypothesis is that impaired sensitivity for emotional distress cues (fear and/or sadness) is mechanistically linked to CU traits in children, and that, by targeting affect sensitivity directly, intervention can exert downstream effects on CU traits. A gap in the field regards how to remediate these neurocognitive deficits. This project will directly target affect sensitivity in high-CU youth. The investigators propose an experimental therapeutics approach to develop a novel neurocognitive intervention for CU traits, in which a clearly identified target, facial affect sensitivity (FAS), will be engaged and assessed via primary (distress FER accuracy and/or heightened eye gaze) and secondary (electroencephalograph event-related potential) neurocognitive and behavioral processes. If investigators can demonstrate engagement of the target (FAS) in the initial R61 phase, then in the R33 phase, this finding will be replicated with a new, larger sample, and feasibility and preliminary efficacy of FAST on CU traits will be examined. The long-term goal is to examine FAST impact on behavioral outcomes and to potentially apply this targeted intervention to the wider range of problems associated with CU traits.

AI-Based Communication Simulation and Human Library Narratives.

This research plan aims to establish an effectiveness assessment system for promoting clinical communication, empathy, and emotion regulation in pediatric nursing students through a combination of AI communication simulation and human library narrative. This study sets five specific objectives: 1. To develop and implement a pediatric nursing teaching model that integrates AI communication simulation and human library narrative. 2. To evaluate the effectiveness of this teaching model in improving nursing students' clinical communication skills. 3. To examine the effectiveness of this teaching intervention in enhancing nursing students' empathy. 4. To explore the impact of this teaching intervention on nursing students' emotion regulation abilities. 5. To understand students' learning experiences, feelings, changes in emotion regulation, and suggestions for improvement regarding this integrated teaching intervention.

Effects of Simulation Fidelity on Patient-Centered Care Competency, Empathy, and Learning Outcomes in Nursing Students: A Randomized Controlled Trial

This randomized controlled trial examines the effects of simulation fidelity on nursing students' patient-centered care competency, empathy, learning self-confidence, and satisfaction. Participants will be randomly assigned to two groups: one group will practice with a standardized patient (actor) and the other with a manikin in a myocardial infarction scenario. All sessions will follow the same structured simulation protocol including briefing, simulation, and debriefing phases. The study aims to provide evidence on whether the type of simulated patient affects learning outcomes in nursing education.

A Virtual Reality Couples' Intervention for Sexual Victimization Prevention: a Gender-swapping Transformative Approach

The goal of this clinical trial is to evaluate the effectiveness of REVISE (REalidad Virtual Inmersiva y SExualidad), an immersive virtual reality (IVR) intervention designed to promote empathy and reduce sexual harassment behaviors in heterosexual cisgender men. The main questions that this study aims to answer are as follows. Does experiencing gender swapping in IVR increase empathy towards survivors of sexual harassment? Does the intervention modify attitudes toward gender roles and sexual harassment? Researchers will compare the three experimental groups to evaluate the effects of IVR: 1. Identity Exchange Group with Exposure to Sexual Harassment: Participants embodied their partner's identity in a VR harassment scenario. 2. Identity Exchange Group without Harassment Exposure: Participants embodied their partner's identity in a neutral VR scenario. 3. Third-person Observer Group: Participants observe a harassment scenario in VR from their own perspective. Participants will: 1. Attend one virtual reality session in a laboratory setting. 2. Undergo pre- and post-intervention assessments and a three-month follow-up. 3. Complete self-report questionnaires and physiological measures (eye tracking and pupillometry). 4. Participate in semi-structured interviews about their experiences. This study aims to explore how immersive VR embodiment can be used as a tool for gender violence prevention by fostering perspective-taking and behavioral change.

AI-Supported Empathy Mapping to Enhance Communication and Grit in Pediatric Nursing Students

The nurse-patient communication environment in pediatric care is characterized by high uncertainty and complexity. Due to children's limited language development and emotional regulation abilities, coupled with parents' high level of involvement, nursing students often experience anxiety, lack of confidence, and avoidance behaviors, which negatively affect their clinical learning outcomes and the establishment of therapeutic relationships. Therefore, providing effective communication support strategies is essential in pediatric nursing education. This study aims to implement an instructional scaffolding model using artificial intelligence (AI)-generated empathy maps to enhance the communication skills, empathy performance, and grit of nursing students during pediatric clinical practicums when encountering communication challenges. A mixed-methods research design was adopted, and the participants were third-year nursing students enrolled in a pediatric nursing practicum course. The teaching intervention included AI-assisted generation of age-appropriate communication strategies, the construction of a grit-oriented empathy map, small group scenario-based exercises, and the application of learned strategies in clinical settings. Quantitative data were collected using pre- and post-intervention assessments, including an empathy scale, a communication skills scale, and a grit scale, to evaluate changes in learning outcomes. Qualitative data, including reflective journals, clinical observations, and focus group interviews, were analyzed to explore students' learning processes and strategy adaptations. Triangulation was applied to strengthen the validity of the findings. It is anticipated that this teaching model will enhance students' understanding of pediatric patients' emotional needs, strengthen their communication strategy application and clinical interaction quality, and promote persistence and adaptability in challenging situations. Through evidence-based teaching practice, this study is expected to provide a feasible and scalable innovative instructional model that supports the effective integration of AI into clinical nursing education, thereby improving pediatric nursing competence and the quality of care for children.

Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children

This study aims to investigate the effects of obstructive sleep apnea (OSA) on executive function and empathy development in children aged 3-12 years. The study will compare the outcomes of different treatment approaches (surgical vs. pharmacological) in children with mild OSA and track the progression of cognitive and emotional functions over 12 months. The study will also explore potential EEG biomarkers for assessing neurological damage in OSA children.

The Test of Those Managing Pain With Their Own Pain

The study aims primarily to investigate physicians' awareness of their health status, empathy towards patients, and management processes through a questionnaire targeting physicians who diagnose and manage patients' pain.

Assessment of Empathy Levels in Dental Hygiene Students and Interns

Empathy is a crucial element in the practice of dentistry, significantly influencing patient satisfaction and treatment outcomes. Recent studies have highlighted the importance of empathy in healthcare, suggesting that it is essential for effective clinician-patient communication and overall quality of care. Despite its recognized value, there is a concerning trend of declining empathy levels among dental students as they progress through their education. This decline may adversely affect their ability to connect with patients, ultimately impacting the quality of dental care provided. In Saudi Arabia, research on empathy within dental education remains limited. A study conducted at King Abdulaziz University indicated that while dental students exhibited a sense of moral obligation, their overall empathy scores were lower than anticipated1. Furthermore, factors such as gender and academic year were found to influence empathy levels, with female students generally scoring higher than their male counterparts. Another study from Dammam reported similar findings, emphasizing the need for targeted interventions to enhance empathy among dental students and interns. This proposed cross-sectional study aims to assess empathy levels among dental hygiene students and interns in Saudi Arabia. By utilizing the Jefferson Scale of Empathy-Health Profession Students (JSE-HPS), this research will explore how demographic factors such as age, gender, and academic year correlate with empathy scores. The insights gained from this study could inform curriculum development and training programs aimed at fostering empathetic communication skills among future dental professionals.

The Optimization and Evaluation of the Extremism and Intolerance Curriculum for the Kingdom of Bahrain.

Researcher from UNC Greensboro have partnered with Prevention Strategies and key stakeholders from the Kingdom of Bahrain to conduct a study using the innovative, engineering-inspired methodological approach, the Multiphase Optimization Strategy (MOST), to optimize and evaluate the Peaceful Coexistence and Anti-Extremism middle and high school curricula. No other curriculum targeting tolerance and/or extremism has been optimized using the state-of-the-art MOST methodology. The overall goal of the project is that the optimized versions of Peaceful Coexistence and Anti-Extremism curricula will be used across the Kingdom of Bahrain and translated for use in other countries to combat the spread of extremism and intolerance. Additionally, the D.A.R.E. keepin' it REAL (kiR) and D.A.R.E. myPlaybook high school programs will be evaluated as part of the Peaceful Coexistence and Anti-Extremism evaluation.

The Effects of Multi-Psycho-Oncology Care Courses

When the patient's mood has not yet reached a moderate to high severity level, psychological support is usually provided by the clinical nurses. However, the result of past research showed that the needs of patients and their caregivers were not satisfied with the psychological level. Scholars pointed out that it may be related to factors such as excessive clinical workload or insufficient psychological support and care capacity. In addition, under the influence of COVID-19 in the past two years, medical staff are facing more physical and mental pressure. Oncology nurses have a heavy workload and are affected by the COVID 19 epidemic, which reflects that nurses need psychological support. Therefore, this study intends to reduce stress through remote physical and mental support activities, and use the Internet to intervene in guided relaxation and meditation. Considering the scheduling of clinical nurses, a remote and unstructured course content that does not require continuity will be selected, and then advanced to provide the empathetic care skills of oncology nurses.

From the Heart: Comparing the Effects of Spiritual and Secular Meditation on Psychophysiology, Cognition, Mental Health, and Social Functioning in Healthy Adults

The purpose of this study is to investigate and compare the effects of Christian and Islamic heart-centred spiritual meditation to mindfulness meditation and waitlist control conditions, respectively, in healthy adults. The potential effects will be studied at multiple levels, with a focus on psychophysiology, cognition, mental health, and social functioning.

Exploring Empathy and Compassion Using Digital Narratives

Stories of suffering and struggle are shared continuously through digital formats such as internet videos, news stories, social marketing, and fundraising campaigns. Digital stories are often created and shared to generate awareness about a problem, impart knowledge on contemporary issues, or promote compassion. The practice of sharing critical life events and insights provided by these experiences are valuable for tellers and the listeners alike for catharsis, healing, reconciliation, and connectiveness. Portrayals of mental suffering are a matter of cultural and social interest as new media products become available to the public. Studies published since the 1990s overwhelmingly conclude that formal media depictions are biased, promoting the stereotype that people who suffer emotionally are mentally ill, dangerous, violent, or insane. Various agencies, organizations, and corporations are actively working to provide alternative stories/narratives to mainstream media by means of video testimonials in social marketing and fundraising campaigns and, ultimately, by taking advantage of the Internet. The impact of this work is under-researched. However, preliminary evaluations of social marketing campaigns report mixed results and raise questions about their effectiveness. As well, the first-person narrative prepared digitally and shared online is also providing alternative narratives to mainstream media stories. People are increasingly using digital videos to share their stories, viewing this as an opportunity to understand their emotions and thoughts, come to terms with disgrace around sensitive, personal issues and marginalization while providing hope and encouragement to others. This proposed study focuses on the process of creating digital narratives/stories, especially stories of mental and emotional suffering, and their impact in terms of inciting empathy, compassion, and good citizenship among viewers.

Empathy Training for Psychology Students Trainees

This study aims to examine the effectiveness of empathy training for psychology student trainees who plan to become mental health practitioners. The training consists of five sessions of psychoeducation, three-role group exercises, and Q\&A. Empathy assessment will be based on self-reported, listener-reported, and observer-reported measurements.

Role of Empathy in Curative Treatment Outcomes of Non-metastatic Colorectal Cancer.

The aim of project EMPACOL will be to investigate, while taking into consideration the clinical factors known and well described in the literature, among the non-clinical factors, in particular, patient-healthcare personnel (HCP) relationship, a link between HCP's empathy perceived by the patient, and the results of the curative treatment of non-metastatic colorectal cancer, throughout the patient's care.