VR-PMR for Post-Burn Symptoms

NCT07317271 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-03-05

No results posted yet for this study

Summary

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)

Conditions

  • Burn
  • Chronic Pain Following Thermal Burn Injury
  • Non-Pharmacological Interventions
  • Virtual Reality
  • Sleep Disturbance
  • Anxiety
  • Depressive Symptoms
  • Fatigue Symptom
  • Pruritus
  • Burn Injury
  • Progressive Muscle Relaxation

Interventions

BEHAVIORAL

Virtual Reality-Enhanced Progressive Muscle Relaxation

The 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.

BEHAVIORAL

Standard Progressive Muscle Relaxation

Standard 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.

Sponsors & Collaborators

Principal Investigators

  • Sheera Lerman Zohar, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-27
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07317271 on ClinicalTrials.gov