跳至主要内容
临床试验/NCT07317271
NCT07317271招募中不适用

Virtual Reality-Enhanced Progressive Muscle Relaxation for Symptom Management in Burn Survivors

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
34
试验地点
1
主要终点
Pain Intensity as assessed by the the Numeric Rating Scale (NRS).

研究概览

简要总结

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)

详细描述

Serious burn injuries are a devastating form of trauma, often resulting in long-term physical and psychological challenges. Burn survivors experience a host of burdensome and co-occurring chronic symptoms post-burn injury that affect quality of life and recovery. Among the most prevalent are pain, pruritis (itch), anxiety, sleep disturbances, and fatigue. Despite a decrease in intensity over time, these symptoms often persist well-beyond the initial burn injury and negatively impact recovery, activities of daily living, social participation, and quality of life. Research indicates that these symptoms often co-occur and demonstrate bidirectional relationships. For instance, pain and itch can contribute to sleep disturbances, while anxiety and fatigue can worsen overall itch and pain perception. A reciprocal relationship between sleep and pain after burn injuries has been demonstrated in a number of studies suggesting that pain contributes to poor sleep, and that disruptions in sleep are associated with increased pain and increased use of analgesics.

Pharmacologic interventions for these symptoms, such as the use of opioids or sedatives, can have adverse effects, including dependence, side effects, and inadequate long-term relief. Given the limitations of pharmacologic interventions, non-pharmacologic therapies, such as cognitive-behavioral therapy (CBT), mindfulness, and relaxation techniques, have gained recognition as effective strategies for symptom management in this population. However, CBT, often regarded as the gold standard intervention for improving sleep and pain, has its own barriers, including the need for trained professionals, high costs, and challenges related to patient adherence. These barriers underscore the need for cost-effective, accessible, and effective self-administered approaches that can be easily integrated into everyday life of burn survivors.

Progressive muscle relaxation (PMR) is a well-established mind-body relaxation technique that has been shown to reduce stress, anxiety, pain, and itch, and improve sleep by systematically tensing and relaxing different muscle groups. Recent advancements in virtual reality (VR) technology present an opportunity to enhance the delivery of PMR by creating immersive environments that promote relaxation and improve therapeutic outcomes. VR has previously been used to enhance existing therapies to help improve engagement and therapeutic by providing an immersive environment that complements the therapy. It has been shown to provide pain relief and reduce anxiety in various clinical settings and populations, such as burn care, procedural pain, and chronic pain management. VR is hypothesized to facilitate a more realistic and relaxing sensory experience and has the potential to amplify the effects of PMR by providing additional relaxing auditory and visual stimuli.

This study would leverage novel VR technology to enhance a well-established mind-body intervention, PMR, to support symptom management in a burn population. While the combination of VR and PMR has been explored in a variety of pain populations, its effect on chronic pain, anxiety, itch, sleep, and fatigue have yet to be explored in a burn population. Therefore, this proposed study seeks to evaluate the use of a novel self-administered VR-enhanced PMR (VR-PMR) therapy delivered at-home for symptom management in burn survivors. The aims for this study are as follows:

Aim 1. Determine the feasibility of an at-home, self-administered VR-enhanced PMR (VR-PMR) and PMR intervention in burn survivors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥18 years old;
  • sustained a burn injury in the last 6 months or longer;
  • Score high on at least one of the following: Insomnia severity index (ISI) score of ≥8, Brief Pain Inventory Short Form (BPI-SF) Pain severity score of ≥3, or PROMIS Itch Severity of ≥55;
  • own a smartphone or computer with reliable internet connection for online visits and survey completion;
  • able to comfortably wear goggles or headsets on face as determined by self-report.

排除标准

  • Cognitive impairment (Mini Mental Status Exam (MMSE) < 25);
  • history of motion sickness, photosensitivity, photoinduced seizures, and claustrophobia as determined by self-report;
  • uncorrected visual or hearing impairments as determined by self-report;
  • non-English speaker.

研究组 & 干预措施

VR-PMR

Experimental

干预措施: Virtual Reality-Enhanced Progressive Muscle Relaxation (Behavioral)

PMR

Active Comparator

干预措施: Standard Progressive Muscle Relaxation (Behavioral)

结局指标

主要结局

Pain Intensity as assessed by the the Numeric Rating Scale (NRS).

时间窗: pre intervention and post VR-PMR intervention (3 weeks)

Pain will be measured using the the Numeric Rating Scale (NRS). Scale range 0-10, higher score worse pain severity.

Itch Intensity as assessed by the the Numeric Rating Scale (NRS)

时间窗: pre intervention and post VR-PMR intervention (3 weeks)

Itch intensity pre- and post-intervention will be measured using the the Numeric Rating Scale (NRS). Scale range 0-10, higher score worse itch severity.

Anxiety as assessed by the Numeric Rating Scale

时间窗: Pre intervention, post VR-PMR intervention (3 weeks)

Anxiety severity pre- and post-intervention will be measured using the Numeric Rating Scale. Total score range from 0-10 with higher scores indicating worse anxiety.

次要结局

  • Quality of Life (Burn Specific Health Scale Brief)(pre intervention and post intervention (3 weeks))
  • Sleep Disturbances as assessed by the PROMIS Sleep Disturbance Scale(pre intervention and post intervention (3 weeks))
  • Total Sleep Time (TST)(pre intervention and post intervention (3 weeks))
  • Wake After Sleep Onset (WASO)(pre intervention and post intervention (3 weeks))
  • Sleep Latency(pre intervention and post intervention (3 weeks))
  • Sleep Efficiency(pre intervention and post intervention (3 weeks))
  • Fatigue as assessed by the Multidimensional Fatigue Inventory(pre intervention and post intervention (3 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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