About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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;
Disqualifiers
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.
Trial design
Crossover
Treatments tested in this trial
Virtual Reality-Enhanced Progressive Muscle Relaxation
BehavioralThe VR-PMR intervention is a self-administered 20-minute session, conducted for 3 consecutive days, one hour before bedtime. PMR, participants will tighten and relax specific muscle groups in sequence from the upper body to the lower body then vice versa. While taking deep breaths inhaling through the nose and exhaling through the mouth, patients will be asked to first tense a muscle tightly and hold for slow count of 5 seconds and then relax quickly and completely for 10 seconds until all the tightness and pain flow out of the muscles. During PMR, participants will be immersed in a relaxing, nature-based VR environment. The VR component will use the Quest 3 Headset. Participants will be immersed in a virtual nature walk with accompanying relaxing music and nature sounds. Participants will be given a choice of three 360 nature walk videos set in forests or a beach. Audio instructions for PMR will play over the video's audio. Participants will use the participant's own smartphone.
Standard Progressive Muscle Relaxation
BehavioralStandard progressive muscle relaxation (PMR) therapy delivered via audio-recorded guides. For PMR, participants will tighten and relax specific muscle groups in sequence from the upper body to the lower body then vice versa. While taking deep breaths inhaling the nose and exhaling through the mouth, patients will be asked to first tense a muscle tightly and hold for slow count of 5 seconds and then relax quickly and completely for 10 seconds until all the tightness and pain flow out of the muscles.
Treatment groups
Trial outcomes
Primary outcomes
Pain Intensity as assessed by the the Numeric Rating Scale (NRS).
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)
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
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.
Secondary outcomes
Quality of Life (Burn Specific Health Scale Brief)
The Burn Specific Health Scale Brief (BSHS-B) will assess quality of life pre- and post-intervention. The BSHS-B consists of 40-items with 9 subscales that measure physical and psychosocial aspects of burn recovery. Total score range 0-160 (sum of score for all items) higher score suggests better quality of life.
Sleep Disturbances as assessed by the PROMIS Sleep Disturbance Scale
The PROMIS Sleep Disturbance scale will be used to measure pre- and post-intervention sleep quality. T score mean = 50, SD = 10 Higher scores indicate worse symptoms.
Total Sleep Time (TST)
Total sleep time (minutes) derived from actigraphy and sleep diary data.
Wake After Sleep Onset (WASO)
Derived from actigraphy and sleep diary data.
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