No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
34 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for adult burn survivors who want to manage chronic symptoms like pain, anxiety, and trouble sleeping. Participants will try two types of relaxation programs at home: one using virtual reality and one without.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have had a burn injury for at least the last 6 months
I have trouble sleeping, pain, or itching
I own a smartphone or computer with internet access
I can comfortably wear goggles or headsets
You may not be able to join if
I have cognitive impairment
I have a history of motion sickness or seizures
I have serious vision or hearing problems that aren't fixed
I do not speak English
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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)
Trial Locations
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City
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Status
Eligibility Criteria
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 sm…
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.
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