AzTrials
AzTrials

BurnVIBENCT07317271

VR-PMR for Post-Burn Symptoms

A study testing Virtual Reality-Enhanced Progressive Muscle Relaxation and Standard Progressive Muscle Relaxation in people with Burn and Chronic Pain Following Thermal Burn Injury, run by Johns Hopkins University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Virtual Reality-Enhanced Progressive Muscle Relaxation and Standard Progressive Muscle Relaxation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
27 Feb 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lynn Nakad, PhD, RN contact

410-550-9056

lnakad1@jhmi.edu

United States1 site, 1 recruiting
  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

    Lynn Nakad, PhD, 410-550-9056, lnakad1@jhmi.edu

    szohar1@jhmi.edu

    Recruiting

Other trials in United States

About this study

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

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:

Read more
  • 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)
Read the detailed description

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.

Aim 1a. Recruitment, enrollment, retention rates, and intervention adherence of participants will be recorded and used to help determine feasibility of the VR-PMR intervention.

Aim 1b. Usability of VR-PMR intervention will be measured with surveys and open-ended prompts for additional qualitative feedback.

Aim 2. Evaluate the preliminary efficacy of VR-PMR and standard PMR interventions on symptom outcomes, including pain severity, itch severity, anxiety, sleep quality, and fatigue, using a within-subject crossover design.

Aim 2a. Compare changes in symptom outcomes across both intervention phases to identify any differential effects.

Aim 2b. Assess the presence of any carryover effects between intervention phases and the potential impact on outcome measures.

Being tested
Virtual Reality-Enhanced Progressive Muscle Relaxation, Standard Progressive Muscle Relaxation
Keywords
Virtual Reality, Burn Survivors, Progressive Muscle Relaxation, Chronic Symptom Management, Pain, Itch, Sleep, Fatigue, Burns, Burn Injury
Medical subject headings
Burns, Parasomnias, Anxiety Disorders, Depression, Fatigue, Pruritus, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality-Enhanced Progressive Muscle RelaxationBehavioural

    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 RelaxationBehavioural

    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.

Study groups in NCT07317271
Study groupRoleWhat they receive
VR-PMRExperimentalNot described
Receives: Behavioral: Virtual Reality-Enhanced Progressive Muscle Relaxation
PMRActive comparatorNot described
Receives: Behavioral: Standard Progressive Muscle Relaxation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (7)
  1. 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.

    Measured: pre intervention and post intervention (3 weeks)

  2. 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.

    Measured: pre intervention and post intervention (3 weeks)

  3. Total Sleep Time (TST)

    Total sleep time (minutes) derived from actigraphy and sleep diary data.

    Measured: pre intervention and post intervention (3 weeks)

  4. Wake After Sleep Onset (WASO)

    Derived from actigraphy and sleep diary data.

    Measured: pre intervention and post intervention (3 weeks)

  5. Sleep Latency

    Derived from actigraphy and sleep diary data. Amount of time measured in minutes it takes to fall asleep.

    Measured: pre intervention and post intervention (3 weeks)

  6. Sleep Efficiency

    Derived from actigraphy and sleep diary data. Percentage total sleep time divided by time in bed.

    Measured: pre intervention and post intervention (3 weeks)

  7. Fatigue as assessed by the Multidimensional Fatigue Inventory

    Fatigue will be measured using the Multidimensional Fatigue Inventory (MFI) at baseline and at the end of the PMR sessions. The MFI is a 20-item scale designed to evaluate 5 dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Scores on each subscale range 4-20. Total score range 20 to 100; higher the score worse fatigue.

    Measured: pre intervention and post intervention (3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2026
  2. Study start27 Feb 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07317271
Sponsor's protocol ID
IRB00488719
Acronym
VIBE
Status last verified
Mar 2026
First submitted
10 Dec 2025
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality-Enhanced Progressive Muscle Relaxation and Standard Progressive Muscle Relaxation in people with Burn and Chronic Pain Following Thermal Burn Injury, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lynn Nakad, PhD, RN (410-550-9056, lnakad1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in