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Showing 1-20 of 395 trials
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.
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.
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.
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.
NCT07380685
Clinical nurses are frequently exposed to high emotional demands due to heavy workloads, time pressure, patient suffering, and the interpersonal complexity of clinical care. These stressors may contribute to compassion fatigue, burnout, reduced resilience, and decreased occupational well-being. However, timely and accessible psychological support is often limited in busy clinical environments, and many nurses may hesitate to seek help due to stigma, time constraints, or limited resources. This study is a prospective, randomized, controlled, parallel-group interventional trial designed to evaluate the feasibility and effectiveness of an on-demand, human-centered emotional support intervention delivered through a LINE-based GPT assistant. The AI assistant provides real-time supportive conversations, reflective prompts, stress-coping guidance, and resilience-enhancing strategies tailored specifically for clinical nurses, offering a private and easily accessible support resource. Eligible clinical nurses (target sample size: 100-120) are randomly assigned to either an Intervention Group, which interacts with the AI assistant, or a Control Group, which receives non-interactive static messages, over a four-week intervention period. Primary outcomes include changes in compassion fatigue, burnout, and compassion satisfaction, as measured by the Professional Quality of Life Scale (ProQOL). Secondary outcomes include changes in resilience (Brief Resilience Scale), general self-efficacy (General Self-Efficacy Scale), and perceived stress (Perceived Stress Scale-10). The results of this study are expected to provide evidence on the feasibility and potential effectiveness of AI-based emotional support as a scalable and accessible tool to promote psychological well-being among clinical nurses, thereby informing future digital mental health interventions in healthcare settings.
NCT06771167
Established in 2021, NYCEAL consists of approximately 40 organizational partners and 120 Community Health Workers (CHWs). Over the next four years (2024-2028), NYCEAL will work with this network to implement the following intervention: Building Community Resilience Program (BCR). To assess the impact of this intervention, an implementation research framework will be used, and pre- and post-surveys conducted, and other process evaluation measures collected. Changes in outcomes measures such as stress, resilience, overall wellbeing, and other related outcomes for participants in the BCR program will be measured for community healthcare workers and/or frontline workers that receive educational workshops.
NCT07457801
The purpose of this study is to compare the effectiveness of two different online education courses (Oxford-Online and Mind-Online) for preventing stress related conditions among paramedics who have been working during a period of COVID-19 occurrence in Singapore. The study aims to: * Compare the efficacy of a locally-adapted version of internet-delivered cognitive training for resilience (Oxford Online) to an existing educational online training (Mind Online) on depressive symptom severity * Compare the efficacy of Oxford Online to Mind Online for improving posttraumatic stress symptoms, resilience, general psychological distress, anxiety symptoms, social support, work engagement, and health-related quality of life Participants will: * Complete an online battery of baseline questionnaires * Be randomised to receive 6 modules of either Oxford Online or Mind Online, delivered once per week over a 6-week period * Complete the same online questionnaire battery immediately following the intervention, and again at the 6-month and 12-month follow up
NCT06162052
The purpose of this study is to examine the effect of participating in a tele-rehabilitation program after a burn.
NCT07279103
This study aims to examine the effects of a multisensory environment-based occupational therapy intervention on sensory processing, cognitive status, behavioral and psychological symptoms, and caregiver burden in individuals diagnosed with Alzheimer's disease. Non-pharmacological approaches in Alzheimer's management have been shown to slow functional decline, reduce behavioral symptoms, and improve caregivers' well-being. Multisensory environments provide visual, auditory, tactile, proprioceptive, vestibular, olfactory, and gustatory stimuli to support sensory integration and enhance engagement, particularly in individuals with cognitive and communication difficulties. The study will be conducted using a randomized controlled design and will include individuals aged 65 years and older with moderate-stage Alzheimer's disease and their primary caregivers. The intervention will be implemented over four weeks with two sessions per week. Outcome measures will include the Adult/Adolescent Sensory Profile,Loewenstein Occupational Therapy Cognitive Assessment-Geriatric version, Neuropsychiatric Inventory, and Zarit Caregiver Burden Inventory. The study is expected to contribute to the evidence base supporting sensory-based occupational therapy interventions in dementia care.
NCT07317271
The goal of this clinical trial is to learn whether progressive muscle relaxation (PMR), delivered either alone or enhanced with virtual reality (VR), can help treat chronic symptom, such as pain, itch, anxiety, sleep disturbances, and fatigue, in adult burn survivors. The main questions it aims to answer are: * Does VR-enhanced PMR (VR-PMR) reduce chronic pain, anxiety, itch, sleep disturbances, and fatigue more effectively than standard PMR? * Is VR-PMR a feasible and acceptable self-administered home-based intervention for burn survivors? Researchers will compare two self-administered intervention conditions, VR-enhanced PMR and standard PMR, using a randomized to sequence crossover design to see if VR technology enhances the therapeutic effects of PMR on chronic symptom management in burn survivors. Participants will: * Complete home-based sessions of VR-enhanced PMR * Complete home-based sessions of standard PMR * Report symptoms such as pain, itch, anxiety, sleep disturbances, and fatigue throughout the study * Use VR equipment provided for the intervention period (during the VR-PMR arm)
NCT06596434
Many patients suffer from traumatic burns and current treatments do not increase the regenerative potential of either skin grafts or the remaining uninjured skin. There is a need to develop treatments to accelerate and improve healing of burn injuries. More research is needed to evaluate the role of 4-AP, a promising new agent with an excellent safety profile, on wound and burn healing. The investigational treatment will be used to test the hypothesis that 4-AP accelerates burn healing in traumatically burned patients.
NCT07435753
This study aims to strengthen leadership competencies among CU SOM faculty who have at least five direct reports by promoting meaningful behavior change in leadership practices and fostering a culture of peer support, to advance employee well-being and help reduce burnout among healthcare professionals. 125 leaders will take part in a six-month leadership development program consisting of 6 self-paced learning focus areas and 6 in-person sessions with peers to discuss. The investigators will evaluate the program's implementation process and its effectiveness in achieving desired outcomes.
NCT07443007
Children who sustain burn injuries often develop long-term physical and psychological complications that limit their ability to move, exercise, and participate in daily activities. These problems commonly include reduced balance, muscle weakness, fatigue, and impaired physical performance, which may persist for several years after injury and require prolonged rehabilitation. This study aims to investigate the effects of three different exercise-based rehabilitation programs-balance training, plyometric (jump-based) training, and a combined balance and plyometric training program-on balance and physical performance in children recovering from burn injuries. A total of 84 children aged 10 to 17 years with healed lower-limb burns will be randomly assigned to one of the three training groups. Each group will participate in supervised exercise sessions three times per week for eight weeks. Balance, muscle strength, power, and agility will be assessed before and after the training period using standardized physical performance tests. The findings of this study are expected to help identify the most effective rehabilitation approach for improving functional abilities and physical performance in pediatric burn survivors during long-term recovery.
NCT05743205
This exploratory pilot study is designed as interventional study to examine the efficacy of a wellness initiative that involves use of a licensed clinical professional counselor (LCPC) to assist in the development of diverse coping strategies such as management of stressors, self-care, time management, and any other goals, problems or concerns that APPs would like assistance with during the intervention period.
NCT07438769
Persistent burn scar pain is common after blast and drone-related injuries and may be driven by scar fibrosis, vascular activity, and peripheral nerve involvement within scar tissue. This prospective cohort study aims to determine whether early ultrasound features of scars and nerves predict persistent clinically significant scar pain at 3 and 6 months. Ultrasound measures include scar thickness, echogenicity, Power Doppler vascularity, dynamic adhesion (gliding) assessment, and ultrasound signs of nerve involvement ("US-nerve positive"). Clinical outcomes include pain intensity (NRS), neuropathic pain screening (DN4), and functional interference.
NCT07411833
The goal of this clinical trial is to evaluate if transcranial direct current stimulation (tDCS) works to reduce occupational stress and burnout in university professors. The main questions it aims to answer are: Does tDCS reduce levels of occupational stress in university professors? Does tDCS reduce burnout levels in university professors? Researchers will compare active tDCS to a sham stimulation (a look-alike procedure that contains no active stimulation) and a control group to see if tDCS effectively reduces stress and burnout. Participants will: * Complete questionnaires assessing stress and burnout levels before the intervention * Complete follow-up assessments immediately after the intervention and 5 weeks later During intervention, participans of active tDCS and Sham gruops will: * Receive 10 sessions of tDCS over 4 weeks (excluding weekends), 20 minutes each
NCT05619289
The goal of this pilot clinical trial is to learn whether vitamin D is able to prevent chronic pain following burn injury and to determine what biological mechanisms are engaged by Vitamin D following burn injury. The main question\[s\] it aims to answer are: * Is the clinical trial protocol feasible? * Is Vitamin D administration following burn injury safe? * How does vitamin D cause changes in the immune system in the aftermath of burn injury? Following informed consent, participants will be asked to: * Take 6 capsules by mouth one time following burn injury (Vitamin D or Placebo) * Provide a blood sample at baseline and 6 weeks following injury * Fill out surveys daily while in the hospital, weekly through 6 weeks, and at 3 months and 6 months. Researchers will compare Vitamin D and placebo groups to see if there are differences in adverse effects (side effects), chronic pain, and profiles of immune cells from collected blood samples.