Recruiting

VR-PMR & PMR

Sponsor:

Johns Hopkins University

Code:

NCT07317271

Conditions

Burn

Chronic Pain Following Thermal Burn Injury

Non-Pharmacological Interventions

Virtual Reality

Sleep Disturbance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual Reality-Enhanced Progressive Muscle Relaxation

Standard Progressive Muscle Relaxation

Study Details

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

Study ID

NCT07317271

Start date

Feb 27, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria are:

  • ≥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.

Exclusion criteria:

  • 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.

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VR-PMR

active comparator: PMR

Interventions

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.

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.

Primary outcome measure

  • Pain Intensity as assessed by the the Numeric Rating Scale (NRS). [ Time Frame: pre intervention and post VR-PMR intervention (3 weeks) ]
  • Itch Intensity as assessed by the the Numeric Rating Scale (NRS) [ Time Frame: pre intervention and post VR-PMR intervention (3 weeks) ]
  • Anxiety as assessed by the Numeric Rating Scale [ Time Frame: Pre intervention, post VR-PMR intervention (3 weeks) ]

Central Contacts and Locations

Central contacts

Lynn Nakad, PhD, RN

410-550-9056lnakad1@jhmi.edu

Locations

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Lynn Nakad, PhD

410-550-9056lnakad1@jhmi.edu

szohar1@jhmi.edu

Principal Investigator:

Sheera Lerman Zohar, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-05.