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Showing 1-20 of 641 trials
NCT07639827
The goal of this clinical trial is to learn if app-based wellness programs can help improve wellbeing and self-compassion for medical residents. This is a pilot study, which is done on a small group of people to learn if a larger study would be useful. The main questions it aims to answer are: 1. Are app-based wellness interventions feasible and acceptable in a high-stress population like medical residents? 2. Can app-based wellness programs improve wellbeing and self-compassion in medical residents? Researchers will compare the app-based wellness program to a time- and attention-matched control program. Participants will: * Complete online questionnaires at the start of the study and again after completion of the wellness program * Be assigned by chance (like a coin toss) to one of two different app-based programs, and will participate in the assigned program for 6 weeks. Both programs will involve weekly lessons and brief, daily exercises. Engagement with these exercises will not be mandatory but highly encouraged.
NCT06925503
Mindfulness in Motion (MIM) is an eight-week evidenced based program designed specifically to help participants learn practical stress reduction, burnout and resiliency building techniques. Content includes didactic instruction, community-building group discussion, mindfulness practices, and gentle yoga. Weekly themes include Willingness to Daily Practice, Mindful Sleep, Vision of Self, Supported by the Breath, Mindful Eating and Yoga, Movement Through Balance, Awareness of Sensation, Clarity and Release, and Staying Grounded and Moving Forward. An Ohio State University endorsed, ADA compliant companion smartphone app reinforces weekly content and offers a variety of individual mind-body and mediations practices. The evidence-based MIM content has been tailored to meet the physical, mental, and emotional needs of student Dance majors at The Ohio State University and integrated into the Dance 2802 course content as Mind-Body Conditioning for second year students. Over the course of the second year student's fall semester, this study will evaluate the effectiveness of this integrated course content on students' perceived stress, burnout, resilience, musculoskeletal injury and discomfort, and weekly respiratory rates. After the semester long course is completed, the students will also assess how well the Mind-Body Conditioning course content was integrated into the required first year seminar for University Dance majors.
NCT06582927
The present study evaluates the efficacy of Mindfulness-Based Attention Training on measures targeting cognitive abilities and emotional well-being in first responders.
NCT07574580
This randomized controlled study will investigate the effects of non-invasive vagus nerve stimulation on inflammatory response and functional recovery in adults with acute burn injuries. Participants will be adults aged 18 to 65 years with second- or third-degree burns involving 5% to 30% of total body surface area and who are enrolled within the first 72 hours after hospitalization. Participants will be randomly assigned to one of two groups. The intervention group will receive non-invasive auricular vagus nerve stimulation in addition to conventional physiotherapy. The control group will receive conventional physiotherapy only. The stimulation will be applied through surface electrodes placed on the auricular region of the ear for 20 minutes per session, for a total of 10 sessions. The main outcomes will be inflammatory response, assessed by C-reactive protein levels, and functional recovery, assessed by the Functional Independence Measure. Assessments will be performed before the intervention and after completion of the 10 treatment sessions.
NCT06555172
This feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with officers in the juvenile legal system and other professionals working directly with legal-involved youth.
NCT06807021
The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery. A cream with FS2 will be used on both the area where the skin graft was placed and the area where the skin was taken (donor site). The cream will be applied after the skin has healed. This study will help us understand if FS2 is safe and effective for mitigating skin scar formation in burn patients.
NCT07556302
This randomized controlled trial aims to evaluate the effectiveness of an empowerment-based psychoeducation program on burnout, self-leadership, mindfulness, and psychological resilience among nurse managers. The study population consists of nurse managers working in healthcare settings. The primary objective of this study is to determine whether the psychoeducation program reduces burnout levels and improves self-leadership, mindfulness, and psychological resilience among nurse managers. The main research questions are as follows: Does the empowerment-based psychoeducation program reduce burnout levels in nurse managers? Does the program improve self-leadership levels in nurse managers? Does the program increase mindfulness levels in nurse managers? Does the program enhance psychological resilience in nurse managers? In this randomized controlled design, participants will be assigned to either an intervention group or a control group. The intervention group will receive a structured empowerment-based psychoeducation program lasting five weeks, while the control group will not receive any intervention. Participants will undergo the following procedures: Completion of baseline (pre-test) assessments (T1) Participation in the psychoeducation program for the intervention group (5 weeks) No intervention for the control group Completion of post-intervention assessments (T2) Completion of follow-up assessments three months after the intervention (T3) The findings of this study are expected to contribute to the development of evidence-based interventions aimed at strengthening managerial competencies and psychological well-being among nurse managers.
NCT07474766
Burnout syndrome is a serious occupational health problem affecting healthcare professionals worldwide. Defined by emotional exhaustion, depersonalisation, and reduced personal accomplishment, its consequences span mental health (depression, anxiety, insomnia, substance use), physical health (cardiovascular problems, chronic fatigue, gastrointestinal disorders), and professional performance (reduced quality of care, absenteeism, staff turnover). Primary care professionals are a particularly high-risk group due to sustained workload, administrative burden, and limited autonomy. Despite the availability of evidence-based interventions - including Cognitive Behavioural Therapy, mindfulness, and organisational strategies - their implementation remains limited. Digital tools have shown promising results, but most mobile applications address stress generically and are costly to develop. Online communities via WhatsApp have emerged as an accessible, low-cost alternative with potential to deliver psychoeducational content and peer support effectively. BurnOutCare is a structured 9-week pilot intervention delivered via WhatsApp, led by Mental Health Nursing professionals, comprising four modules: mindfulness, emotional regulation, conflict resolution, and burnout prevention. Content is shared three times per week using short texts, guided audio exercises, brief videos, interactive surveys, and infographics. A private individual channel provides personalised support. The study aims to assess the feasibility and preliminary effectiveness of this approach in primary care professionals at OSI Barrualde-Galdakao (Basque Country, Spain), and to generate validated content and evidence to inform the future development of a purpose-built web/mobile health application for burnout prevention.
NCT07544498
This study investigates the effectiveness of an extended reality (XR) based resilience training program designed to support the mental health and well-being of nurses working in hospital settings. Nurses are exposed to high emotional, cognitive, and organizational demands and show elevated levels of work-related stress and stress-associated mental health problems. Strengthening resilience and coping capacities is therefore an important preventive approach to support nurses' well-being and sustain quality of care. The study is conducted as a pragmatic randomized controlled trial with a waitlist control group and includes approximately 232 nurses from hospitals in several European countries. Participants are randomly assigned either to an XR-based resilience training group or to a waitlist control group that continues with care as usual during the waiting period. The XR-based intervention consists of eight immersive training sessions delivered over approximately ten weeks using a head-mounted display. The training focuses on behavioral, cognitive, and emotional coping strategies and aims to enhance key resilience factors such as problem-solving, cognitive reappraisal, emotion regulation, and positive self-care. The primary outcome is perceived stress, assessed using the Perceived Stress Scale. Secondary outcomes include resilience, occupational self-efficacy, quality of life, psychological distress, burnout symptoms, coping strategies, work-related rumination, and turnover intentions. Assessments are conducted at baseline, post-intervention, and at a 20-week follow-up. In addition, a subgroup of participants will optionally provide physiological data during selected XR sessions to explore digital biomarkers related to stress and recovery. The findings of this study will provide evidence on the effectiveness, feasibility, and acceptance of XR-based resilience training for nurses and inform future implementation of digital mental health interventions in healthcare workplaces.
NCT07530003
To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells combined with bovine type I collagen in the treatment of third-degree burn wounds.
NCT06992895
The process of dressing burn injuries has been shown to cause both physical and psychological difficulties. In children, this process is particularly associated with intense pain and anxiety. Consequently, in addition to pharmacological interventions, non-pharmacological methods such as distraction are employed. In recent years, the utilization of holograms as a method of alleviating pain has emerged as a novel approach. The employment of these visual illusions has been demonstrated to effectively distract children, thereby providing a means of reducing discomfort. The objective of this thesis is to evaluate the effects of hologram application on pain, anxiety, fear, and vital signs during burn dressing in children.
NCT07028788
This randomized controlled trial aims to evaluate the effectiveness of a mobile- and virtual reality-based mindfulness and breathing intervention on stress, burnout, sleep quality, and cognitive function among Rotating-shift nurses. Participants will be randomly assigned to one of four groups: (1) health education control group, (2) mobile-based mindfulness only, (3) mobile-based mindfulness combined with brief structured breathing, and (4) virtual reality-assisted mindfulness combined with brief structured breathing. The intervention will last for 8 weeks, with participants practicing 5 times per week for 10 minutes per session. Primary outcomes include perceived stress, burnout levels, sleep quality, and cognitive function.
NCT07195539
It will be a case within control trial. After IRB approval patients presenting with more than 6 months old hyperpigmented burn scars will be included in this study. All data (including age, gender, mode of burn) will be recorded on a proforma and standardized pre-intervention photographs will be taken. The hyperpigmented scar will be divided into two equal halves.One half will receive fractional CO2 wit TXA solution other half will receive fractional CO2 Laser with N/S solution.Thus allocation will be done randomly with the lottery method. Total 3 sessions of LADD will be done with 1 month interval between each session. The following settings will be used: probe frequency 75Hz; Power range 12-15W; dwell time 300 micros-500 micros, stach 1-2 and spacing 900-1200m. The TXN solution will be prepared by mixing 250mg of TXA in 5ml of N/S creating a 5% TXN solution. Standardized photographs will again be taken 3 months after the 3rd session. The pre- and post-treatment photographs will be assessed by Skin Hyperpigmentation Index (SHI) using a smartphone dermatoscope adapter and an online calculator, freely available at: https://shi.skini magea nalys is.com, can be used. 15. Any complications during treatment will be noted and documented. Patient satisfaction wil be measured on a Likert scale of 1-5.
NCT07507448
This randomized controlled trial aims to evaluate the effects of virtual reality (VR) and smartphone-based distraction methods on pain and anxiety during dressing changes in outpatients with burns. A total of 99 patients, with 33 in each group, will be randomly assigned to VR, smartphone, or control groups. Pain and anxiety will be assessed immediately after dressing using the Visual Analog Scale (VAS) and Burn-Specific Pain Anxiety Scale (BSPAS). The study is expected to provide evidence on non-pharmacological distraction methods that may improve patient comfort during burn care.
NCT07489560
This study will evaluate the efficacy of a dehydrated human placental tissue product, commercially labeled as AmCoreMatrix Burn ™ versus SOC in the closure of partial thickness burns. Human Cellular and Tissue based Products (HCT/Ps), specifically Dehydrated Human Amnion - Intermediate Layer - Chorion Membrane (dHAICM) offer a multimodal biological approach to burn management. Unlike synthetic dressings or silver-based creams, dHAICM serves as a sophisticated bioactive scaffold. It is a minimally manipulated allograft that provides superior tensile strength and barrier function compared to single-layer membranes. This study aims to document its performance in hospital burn units.
NCT04820400
Burn injury and its treatment is an intensely painful experience. Most severely injured patients require numerous dressing changes and skin grafting procedures (removing skin from healthy part of the body and moving it to damaged area of the body). This procedure cause extensive pain and anxiety and many patients can become dependent on pain killers during their hospital stay and throughout rehabilitation. This can delay reintegration into society and increase the chance of opioid dependence. An effective pain management plan plays a large role in patient recovery. In addition to the physical pain experienced by these patients, burn injury is an intensely stressful and emotional life experience. This study will use a non-drug approach to reduce pain and extensive use of pain killers (opioids) during dressing changes. In particular, the study will use an immersive (allows to experience computer-generated environment as a real world) Virtual reality (VR) distraction tool during dressing change after skin graft surgery. Individuals who will decide to participate in this study will be asked to wear headgear to view immersive 360 videos specially designed by the study team. Before and after this exposure participants will be asked to complete a measurement of their anxiety level (VAS) and rate their pain. This study will help to determine if using VR as a distraction tool during painful dressing changes will reduce pain and anxiety, and therefore opioid medications requirements, and will rely on participants experience and adapt VR videos according to participants' response.
NCT07212998
The Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) trial will be a 6-year (4-year enrollment), open label, phase-3, multi-center, early in-hospital phase randomized trial utilizing burn centers from within the LITES network and will enroll approximately 750 injured adult patients who have suffered large 2nd or 3rd degree thermal burns on at least 20% of their body surface requiring burn resusciation. The objective is to determine if initiating plasma resuscitation as soon as possible upon arrival to an emergency department or burn unit is the most effective resuscitation for those who have experienced large thermal burns and significantly reduces the morbidity and mortality attributable to post-injury complications as compared to standard in-hospital resuscitation practice.
NCT07453927
Background: The donor site (DS) in patients with severe burns is often associated with complications that may delay healing and negatively affect clinical outcomes. Impaired re-epithelialization, pain, inflammation, and risk of infection represent relevant challenges in burn care. Blue light (BL) photobiomodulation has demonstrated beneficial effects in different types of skin lesions, including modulation of inflammation and stimulation of tissue repair. Therefore, BL therapy may represent an innovative and non-invasive strategy to enhance DS healing and improve overall recovery. Methods: This protocol describes an interventional, controlled, prospective, single-center, post-market clinical study enrolling 25 patients with intermediate and deep burn injuries. A CE-marked device emitting BL will be used. Each participant will receive both treatments through an intra-patient controlled design: one DS area will be treated with Standard of Care (SoC) alone, while a second DS will receive SoC combined with BL therapy. This approach allows direct comparison of clinical outcomes within the same patient, minimizing inter-individual variability. The primary outcome is the comparison of DS healing time between areas treated with BL plus SoC and those treated with SoC alone. Secondary outcomes include assessment of wound bed characteristics using the Wound Bed Score (WBS), evaluation of pain intensity during the healing process through the Numeric Pain Rating Scale (NRS), and identification of clinical signs of infection by performing skin swabs on both treated and untreated areas. Safety will be assessed by monitoring local adverse reactions related to BL exposure, such as erythema, burning sensation, heat perception, skin irritation, or pruritus. Long-term scar quality will be evaluated at 1 and 3 months after complete healing using the Vancouver Scar Scale (VSS), allowing comparison of aesthetic and functional outcomes between the two treatment approaches. Follow-up visits at 1 and 3 months will also enable detection of late adverse events and confirmation of the persistence of therapeutic effects. Discussion/Conclusion: BL photobiomodulation appears to be a promising and well-tolerated adjunctive therapy for DS management in burn patients. This study aims to generate clinical evidence supporting its effectiveness and potential integration into routine burn care practice.
NCT06787690
The goal of this study is to look at clinical outcomes when Cohealyx Collagen Matrix is used to treat full thickness wounds after surgical excision in patients that require a skin graft to heal their wounds. The main question it aims to answer is how long does it take for Cohealyx to support definitive closure.
NCT07465809
This interventional study evaluates the effectiveness of two 10-week self-regulation training programs (coaching-based and mindfulness-based) designed to enhance mental health and employability resources among healthcare workers (HCWs). Participants are allocated into two intervention arms based on their baseline level of emotional self-regulation. The study applies a non-randomized controlled pre-test/post-test design. The primary outcome is change in employability. Secondary outcomes include mental health indicators, such as perceived stress, anxiety, depressive symptoms and self-regulation. A follow-up assessment was conducted six weeks after the post-test. Additionally, qualitative semi-structured interviews were conducted to explore participants' subjective experiences with the interventions.