VR-PMR for Post-Burn Symptoms

NCT07317271 | Recruiting

• 1 other identifier: IRB00488719
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Virtual Reality; Burn Survivors; Progressive Muscle Relaxation; Chronic Symptom Management; Pain; Itch; Sleep; Fatigue; Burns; Burn Injury

Outcome Measures

Primary Outcomes (3)

• 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.

  pre intervention and post VR-PMR intervention (3 weeks)

• 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.

  pre intervention and post VR-PMR intervention (3 weeks)

• 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.

  Pre intervention, post VR-PMR intervention (3 weeks)

Secondary Outcomes (7)

• 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)

Study Arms (2)

VR-PMR

EXPERIMENTAL

Behavioral: Virtual Reality-Enhanced Progressive Muscle Relaxation

PMR

ACTIVE COMPARATOR

Behavioral: Standard Progressive Muscle Relaxation

Interventions

Virtual Reality-Enhanced Progressive Muscle Relaxation BEHAVIORAL

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.

VR-PMR

Standard Progressive Muscle Relaxation BEHAVIORAL

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.

PMR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Burns; Parasomnias; Anxiety Disorders; Depression; Fatigue; Pruritus; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Neurologic Manifestations

Study Officials

• Sheera Lerman Zohar, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynn Nakad, PhD, RN

CONTACT

410-550-9056; lnakad1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a randomized, two-period, two-treatment crossover interventional model to compare the effects of standard PMR with VR-enhanced PMR (VR-PMR). Each participant receives both interventions in a randomized sequence, allowing each individual to serve as the individual's own control. This design improves statistical power with a relatively small sample and minimizes confounding from inter-individual differences such as burn severity, baseline symptom levels, and psychosocial characteristics.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 5, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)