Clinical Research Directory

Nature-based Outdoor Activities for Promoting Stress Resilience in Employees

The goal of this randomized controlled trial (RCT) is to assess the impact of a nature-based workplace intervention on stress resilience in full-time employees in Hong Kong. The main question it aims to answer is: Does a nature-based group activity intervention improve stress resilience in employees? Researchers will compare the intervention group (participants who attend three nature-based group sessions) to the control group (participants who receive no intervention and continue their usual routines) to see if the nature-based activities lead to greater improvements in stress resilience compared to no intervention. Participants will complete baseline measurements (questionnaires, blood pressure, and heart rate variability) one week before the first session. If assigned to the intervention group: Attend three one-hour group sessions at a nearby park (once every two weeks, 8:00-9:00 AM) involving mindful walking, gentle movement, nature observation, breathing exercises, and group reflection If assigned to the control group: Continue their usual daily routines with no specific activities Complete follow-up assessments (same measurements as baseline): immediately after the second session and one week after the third session Primary measurement: HRV Secondary measurements: Blood pressure, Perceived stress scale (PSS) and the Difficulties in emotion regulation scale (DERS).

Effect of Magnesium-, Vitamin C- and Grape Seed Extract-Enriched Date Bars on Perceived Stress and Salivary Cortisol Levels in Young Women

This randomized controlled trial aims to evaluate the effect of a 4-week daily consumption of a functional date bar enriched with magnesium, vitamin C, and grape seed extract on perceived stress and salivary cortisol levels in healthy young women. Participants will be randomly assigned to either an intervention group receiving the enriched bar or a control group receiving a placebo bar identical in appearance and taste. Primary outcomes include changes in salivary cortisol levels and perceived stress (PSS-14).

The Effectiveness of Acupuncture on Headaches in Women Undergoing IVF Egg Stimulation

To test the effect of acupuncture in treating headaches, as well as co-measures of stress and emotional distress, in participants during the hormonal stimulation phase prior to an oocyte retrieval. Subjects were identified females at birth experiencing a headache while undergoing a hormone stimulation cycle as part of in vitro fertilization or oocyte cryopreservation. Intervention was an individualized acupuncture treatment with needle retention for thirty minutes. Main outcome measured were headache intensity, level of stress, level of emotional distress.

Limosilactobacillus Fermentum CRL 1446 - CONICET CASASCO

This research study aims to determine if a probiotic called Limosilactobacillus fermentum CRL 1446 can improve the health of people at risk for cardiovascular disease. The study will be conducted with volunteers who will randomly consume either the probiotic or a placebo (a capsule without the probiotic), without knowing which one they are taking. The researchers will analyze how the probiotic affects blood sugar control, body composition, inflammation, and oxidative stress. The goal is to determine if this beneficial bacterium, by influencing the gut microbiota, could be a new strategy to prevent or mitigate chronic heart diseases.

Strengthening the Parent-Child Relationship Through Urban Nature

The study uses an experimental design (RCT) to estimate the causal impact of nature-based activities on the parent-child relationship and children's emotional regulation without random assignment. After consenting to participate, all students were asked to complete a questionnaire containing questions from six validated scales to measure baseline social health and well-being conditions. i.e. Nature Connection Index (NCI), Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS), Child-parent relationship scale (CPRS), and Children's Emotion Management Scale (CEMS). For the intervention group, 50 low-income families will be invited to experience touching the lawn barefoot and lying down to relax. Participants will also engage in nature-based games to enhance their well-being, increase creativity, and improve mood. Additionally, collective nature-inspired music and jamming activities will facilitate social bonding and encourage community interaction, while supporting participants in forming habits of connecting with nature in daily life for sustainable overall well-being. The families in the control group were not asked any specific tasks during the period. After completing the nature-based activity, participants will be asked to complete the initial questionnaire again. Considering the importance of a connection with nature in early childhood and throughout life, this study attempts to explore how nature-based activities enhance family relationships and children's emotional management.

Health Surveillance at Constructor University Bremen (CUB) and Among HAW-Hamburg Employees

The aim of Health Surveillance is to analyze and describe the state of health of students at Constructor University, key influencing factors and individual resources by using mixed-method design.

Caring for Dementia Caregivers in Ethnic Immigrant Communities

Many caregivers of people with Alzheimer's disease or other dementias-especially those in immigrant communities who don't speak English well-don't get access to helpful, proven support programs. This is especially true for Korean American caregivers. To address this, the investigative team adapted an existing caregiver support program (called the Savvy Caregiver Program) to better fit Korean culture and language. This new version, called K-Savvy, is a 6-week online program taught in Korean. In an earlier small study, K-Savvy worked well: caregivers found it helpful, were willing to use it, and showed fewer symptoms of depression. Now, the investigative team wants to study it more carefully to see how well it really works and why. The study has two main goals: Goal 1: The investigative team will measure whether K-Savvy improves caregivers' well-being-specifically whether it reduces stress and depression and helps them feel more positive about caregiving. The investigative team will also look at why it works, focusing on whether it changes how caregivers think about their situation (for example, feeling less overwhelmed and more confident). Goal 2: The investigative team will talk directly with caregivers and program instructors to understand their experiences with K-Savvy. This will help the investigative team learn what worked well, what didn't, and why.

Impact of OnabotulinumtoxinA (BOTOX®) on Stress

The purpose of this prospective single-center, blinded\*, randomized, proof-of-concept study is to determine whether OnabotulinumtoxinA (BOTOX®) injections will change the level of stress perceived by generally healthy adult female participants. It is hypothesized that BOTOX® injections will be associated with decreases in perceived stress levels, measured by scores on the Perceived Stress Scale (PSS) questionnaire. The primary outcome measure is a chronological decrease in PSS scores between any two points of the study period. Comparison of the placebo- and BOTOX®-treated participant scores will either support or disprove the study hypothesis. Qualified participants who meet the study requirements, including a one-time completion of basic laboratory testing before treatment. The treatment visit starts on day-1 of a 12-week period, which consists a total of four clinic visits and one online visit, which involve: * vital signs and Body Mass Index (BMI) measurements * basic/interval history and physical * 2 Perceived Stress Scale (PSS) questionnaires * injection of 64 units of either BOTOX® or sterile salt solution * stay for 60-minutes after treatment for monitoring and to complete study tasks

HBM-Based Solution-Focused Birth Program on Fear of Childbirth in Primigravidas

Pregnancy is a period characterized by significant physiological and psychosocial changes, during which women adapt to new roles. While some women experience this period with excitement and hope, others may experience anxiety, uncertainty, and fear. Fear of childbirth (tokophobia) is a common condition that can negatively affect women's quality of life, birth preferences, and childbirth experiences. High levels of fear of childbirth have been associated with increased cesarean section rates, negative birth perceptions, and postpartum psychological problems. This randomized controlled trial aims to evaluate the effect of a solution-focused childbirth preparation education program based on the Health Belief Model on fear of childbirth and belief in normal birth among primigravida women. Secondary outcomes include pregnancy-related stress and mode of delivery. Participants will be randomly assigned to either an intervention group receiving structured education or a control group receiving routine prenatal care. Data will be collected before and after the intervention using validated measurement tools, and delivery outcomes will be recorded after birth. The findings are expected to contribute to improving maternal psychological well-being and promoting positive childbirth experiences.

Development and Multicenter Validation of an AI-Based Remote Photoplethysmography (rPPG) Facial Scan for Multimodal Health Assessment

The goal of this observational study is to learn if a non-contact facial scan using artificial intelligence (AI) can be used to check health status in adults living in urban areas such as Jakarta. The facial scan uses a method called remote photoplethysmography (rPPG), which measures small changes in blood flow from the face using a camera. The main questions this study aims to answer are: 1. How close are the results from the facial scan to standard medical measurements, such as heart rate, breathing rate, blood pressure, and oxygen levels? 2. Can the facial scan estimate other health indicators, such as blood sugar, lipid profile, HbA1c, and hemoglobin levels? 3. Is there a relationship between the facial scan results and mental health, such as stress, anxiety, and depression? Participants will take part in several simple and mostly non-invasive procedures: 1. Answer questionnaires about their mental health and daily habits 2. Have basic health checks, such as blood pressure, heart rate, and body measurements 3. Provide a blood sample for laboratory testing 4. Complete a facial scan using a camera for about 1 to 3 minutes Researchers will compare the results from the facial scan with standard clinical and laboratory tests to see how well the technology works. This study may help develop a simple and accessible screening tool that can be used for early detection of health risks. It may also support the use of digital health and telemedicine in community and clinical settings.

Effects of Brief Nature Exposure on Brain Functioning and Stress Reactivity

This study is focused on understanding the impact of time spent in nature (relative to an urban control) on stress, neural, and cardiac functioning in people experiencing high levels of stress, depression, and anxiety.

Smartphone Climate Adaptation and IPV Intervention for Women in Informal Settlements in Kenya

This study is testing a smartphone-delivered program to help women living in informal settlements in Kenya manage intimate partner violence (IPV) and stress related to extreme weather events. Women in these communities often face high levels of violence from partners, challenges caused by climate-related events, and limited access to support services. Participants will be randomly assigned to either a mobile intervention or a comparison condition. The mobile program provides short, tailored sessions that help women learn safety planning, coping skills, and strategies for adapting to climate-related stress. The program also offers tools to improve communication and strengthen social support. The main goal of the study is to see whether this smartphone-based approach can reduce the frequency and severity of IPV over 12 months. The study will also examine changes in stress levels, self-confidence in handling problems, social support, and safety behaviors. Results from this study may help create accessible, scalable support for women experiencing IPV and climate-related stress in similar settings.

Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples

Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. However, few interventions begin building these necessary components in pregnancy prior to the extremely stressful period immediately post-partum, where little trait and behavioural modification occurs. More importantly, most interventions overlook the importance of having both partners, despite fathers/partners playing a significant role in influencing maternal stress and mood symptoms. This goal of this study is to examine whether short weekly exercises delivered through a mobile app can help first-time parents feel better emotionally during pregnancy. These exercises are designed to help people manage their emotions and stress. Researchers want to know if doing these exercises, along with getting weekly feedback and encouragement, can reduce signs of depression and improve emotional control. Expecting mothers and fathers who are having their first child may be able to join the study if they meet certain conditions. Participants should be planning to stay in Singapore for the next two years and be comfortable using a smartphone and answering questions in English. Participants may benefit from learning new ways to manage stress and emotions, which could help improve their mental health. Participants will wear a Fitbit watch to track activity. They will complete a short weekly survey about their well-being during pregnancy and a monthly survey about their work productivity until six months after the baby is born. They will also answer online surveys about their health, relationships, and background at the start, three times during pregnancy, and three times after birth. In addition, they will visit the research lab twice to take part in tasks that measure thinking and behaviour.

HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition

The goal of this clinical trial is to learn if Heart Rate Variability Biofeedback (HRVB) can reduce stress and anxiety in dentistry students during the transition from pre-clinical training to clinical practice. The main questions this study aims to answer are: 1. Does HRVB training reduce perceived stress, measured with the Perceived Stress Scale (PSS-10), from baseline to post-intervention and to 2-month follow-up? 2. Does HRVB training reduce psychological distress, measured with the Kessler Psychological Distress Scale, 10-item version (K-10), from baseline to post-intervention and to 2-month follow-up? 3. Does HRVB training reduce anxiety, measured with the State-Trait Anxiety Inventory, Form Y, State subscale state anxiety (STAI Y-1), from baseline to post-intervention and to 2-month follow-up? Researchers will compare an HRVB training group to a control group (no intervention) to see if HRVB leads to greater improvements in stress, distress, and anxiety across the study time points. Participants will: * Receive study information and provide electronic informed consent. * Complete online baseline questionnaires (sociodemographic questionnaire, K-10, PSS-10, and STAI Y-1). * Be randomly assigned to one of two groups: HRVB training or control (no intervention). * If assigned to the HRVB group, complete a 5-week program with 10 sessions (twice per week; about 10 minutes per session) using an emWave2 HRVB device; participants will practice slow breathing (about 6 breaths per minute) while recalling a positive memory, with real-time feedback provided in a game format. * If assigned to the HRVB group, practice the breathing exercise daily. * If assigned to the control group, not receive HRVB sessions or daily breathing training as part of the study, and only complete the study assessments at the scheduled time points. * Complete the post-intervention assessment online after the intervention period (same questionnaires as baseline except the sociodemographic questionnaire). * Complete a follow-up assessment online about 2 months after the end of the intervention period; participants will be contacted by email to complete this follow-up questionnaire.

(MAP) Pilot Randomized Controlled Trial for Older Adults With Mild Cognitive Impairment and Elevated Stress

The purpose of this study is to test whether a tailored mindfulness program, called the Mindful Awareness Practice (MAP) or a Health Education Program (HEP) can reduce stress and improve memory, mood, and well-being in older adults with Mild Cognitive Impairment (MCI) and elevated stress.

Stress Management Intervention for Young Turkish Women

This pilot study aims to evaluate the feasibility and probable impact of a low intensity psychosocial intervention program designed to help individuals to manage their stress levels. Consequently, this study will implement and measure the feasibility, randomization, retention, assessment procedures, and preliminary effects of the Self-Help Plus (SH+) program developed by the World Health Organization. This intervention, which has been used among immigrants and has proven to be effective, is intended to be implemented for the first time among distressed young Turkish-speaking women in Türkiye (ages between 18 and 29). Participants who will receive this intervention program will be compared with others in the control group who experience similar stress levels but will not receive SH+ during the trial period. Participants in the control group will receive SH+ after the completion of follow-up assessments at 3 months.

A Mindfulness-Based Intervention to Reduce Stress Through the Cultivation of Loving-Kindness, Compassion, Joy, and Equanimity in Healthcare Professionals

Nearly 50% of the adult workforce experience adverse psychological symptoms (e.g., stress, depression, burnout, etc.) stemming from workplace stressors, with healthcare workers experiencing rates as high as 80%. Some common complaints and downstream consequences of working in high-stress healthcare occupations are elevated levels of perceived stress, depression, and burnout. These conditions have been associated with unfavorable occupational (e.g., increased medical errors), patient (e.g., increased mortality rates), and provider-related outcomes (e.g., increased rates of cardiovascular disease), imposing a heavy burden on an already stretched system. Given the impact of perceived stress, depression, and burnout on employee and patient health, a clear need exists to develop effective interventions to reduce distress and promote well-being among healthcare professionals. In particular, interventions that target processes particularly vulnerable to provider stress (e.g., compassion) are needed. The present study will evaluate the feasibility and efficacy of a mindfulness-based intervention inspired by the Buddhist Four Immeasurables practice on reducing perceived stress (primary outcome), depressive symptoms, burnout, and biological markers of inflammation, and enhancing psychological well-being and sleep quality (secondary outcomes) in 80 healthcare workers. Additionally, we will investigate several mediators (compassion, positive emotions, equanimity, and mindfulness) of intervention effects. Participants will be healthcare employees of UCLA Health. They will be enrolled in a six-week, two-arm randomized controlled trial. Participants will complete self-report questionnaires at baseline, mid-course, and post-intervention to assess study outcomes and mediators. We aim to advance the study of interventions that reduce distress and promote well-being using practices that cultivate kind feelings toward oneself and others.

Mindful-Med: the Evaluation of the Mindfulness-based Stress-coping and Burnout Prevention Programme for Medical Interns.

The aim of this study is to evaluate the feasibility and acceptability of a mindfulness-based healthcare education (MBHC) programme with medical interns. Specific objectives are to: * Recruit at least 24 participants to the study. * Examine the feasibility (recruitment and retention rates) and acceptability of the MBHC programme. * Conduct a focus group process evaluation, exploring the interns' perceptions of the MBHC programme, including their adherence to and views on the acceptability of the MBHC programme for medical interns.

Evaluating Healthcare Professionals' Satisfaction and Stress Mitigation Using Virtual Reality Intervention in Surgical Ward

The goal of this feasibility study is to learn whether a VR intervention is feasible, acceptable, and satisfactory for healthcare workers in surgical wards to help mitigate stress. Secondary objectives include assessing its potential contribution to stress reduction, user comfort, and practical integration into daily workflows. Participants will take part in a single 10-minute VR intervention session.