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Pain, AcuteNCT03491657

Virtual Reality Analgesia for Pediatric Burn Survivors

A study testing virtual reality distraction (Yes VR) and music distraction (No VR) in people with Pain, Acute, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Many children with large severe burns report severe pain during burn wound cleaning. The current study explores whether adjunctive immersive Virtual Reality distraction may help reduce the intensity of pain experienced by children during burn wound cleaning by taking the patient's mind off their pain. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Pain, Acute
What is being tested?
virtual reality distraction (Yes VR) and music distraction (No VR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
13 Mar 2014to 3 Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

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 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Compliant and able to complete subjective evaluations,
  • A minimum of 10% of total burned surface area,
  • No history of psychiatric (DSM-III-R Axis I) disorder(s),
  • Not demonstrating delirium, psychosis or any form of organic brain disorder,
  • Able to communicate verbally in English or Spanish,
  • Admitted to UTMB/Shriners, 6-17 years of age.

Who cannot join

  • No wound cleaning sessions required.
  • Less than 10% of total burned surface area.
  • History of psychiatric (DSM-III-R Axis I) disorder(s).
  • Demonstrating delirium, psychosis or organic brain disorder.
  • Unable to communicate verbally in English or Spanish.
  • History of significant cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal, or genitourinary impairment.
Show all 10Show fewer
  • Receiving prophylaxis for alcohol or drug withdrawal,
  • Developmental disability, Younger than 6 years; older than 17 years,
  • Burns of eyes, eyelids or face so severe they preclude the use of VR,
  • Worst pain intensity of less than 5 on a 0 to 10 scale, during baseline No VR wound care Day 1.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Shriners Hospital for Children; Shriners Burns Hospital

    Galveston, Texas, 77550

Other trials in United States

About this study

Many children with large severe burns report severe pain during burn wound cleaning. The current study explores whether adjunctive immersive Virtual Reality distraction may help reduce the intensity of pain experienced by children during burn wound cleaning by taking the patient's mind off their pain.

Read the detailed description

All patients always receive their usual pain medications. Using a within-subjects, within-wound care design, in the current study, pediatric patients being treated for severe burn injuries will receive music distraction during some portions of their wound care (active comparator condition), and they will receive what we predict will be an unusually strong distraction, immersive virtual reality (the experimental treatment) during other comparable portions of the same wound cleaning sessions. During virtual reality, each patient will look into virtual reality goggles, and will play a simple cartoon-like virtual reality game SnowWorld during burn wound cleaning. After each wound care session, the patient will rate how much pain they experienced during wound care during No VR (music only) compared to how much pain they experienced during wound care during virtual reality, on each study day, for up to 10 study days per patient. Treatment order randomized.

Conditions
Pain, Acute
Being tested
virtual reality distraction (Yes VR), music distraction (No VR)
Keywords
virtual reality pain, opioid, pediatric burn, wound care
Medical subject headings
Acute Pain

What participants receive

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

  • virtual reality distraction (Yes VR)Behavioural

  • music distraction (No VR)Behavioural

Study groups in NCT03491657
Study groupRoleWhat they receive
virtual reality distraction (Yes VR)ExperimentalIn addition to their standard pain medications, patients will play a virtual realty game named SnowWorld during some portions of their burn wound cleaning procedure, on each study day.
Receives: Behavioral: virtual reality distraction (Yes VR)
music distraction (No VR condition)Active comparatorIn addition to their standard pain medications, patients will listen to music during comparable portions of their burn wound cleaning procedure, on each study day.
Receives: Behavioral: music distraction (No VR)

What is being measured

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

  1. "Worst Pain" rating of pain intensity during Music vs. during VR

    worst pain during wound care. This single question measures the sensory component of pain during wound care. Patients will rate their "worst pain" during burn wound care. on a zero to ten scale, where zero is "no pain at all " and 10 is "excruciating pain". Lower scores represent better outcome. No subscales.

    Measured: measured after burn wound care on each study day for up to 10 study days per patient

Secondary outcomes (5)

  1. Graphic Rating Scale "Time spent thinking about pain" during Music vs. during VR

    This single question measures the Cognitive component of pain during wound care. Patients will rate how much time they spent thinking about pain during burn wound care, on a zero to ten scale, where zero is "no time at all" and 10 is "the entire time". Lower scores represent better outcome. No subscales.

    Measured: measured after burn wound care on each study day for up to 10 study days per patient

  2. Graphic Ratings Scale measure of pain unpleasantness during Music vs. during VR

    This single question measures the emotional component of pain. On a scale from zero to ten, where zero is "not unpleasant at all", 10 is "excruciatingly unpleasant". Lower scores represent better outcome. No subscales.

    Measured: measured after woundcare on each study day for up to 10 study days per patient

  3. Graphic Rating Scale "Fun" during Music vs. during VR

    This single question measures positive affect during burn wound care. On a zero to ten scale, where zero is no fun at all and 10 is extremely fun. Higher scores represent better outcome. No subscales.

    Measured: measured after wound care on each study day for up to 10 study days per patient

  4. Graphic Rating Scale Satisfaction with pain management during Music vs. during VR

    This single question measures how satisfied the patient is with how well their pain was controlled during burn wound care. Higher scores represent better ourcomes. No subscales

    Measured: Measured after wound care on Study Day 1.

  5. Child Health Questionnaire

    Child Health Questionnaire The Child Health Questionnaire (CHQ) is a family of generic QOL instruments. The CHQ includes 87 scales that consider the effects of children's health on family functioning, and specific scales such as behavior and self-esteem. The CHQ measures 14 unique physical and psychosocial concepts. Questionnaires will be self-completed by the outpatients or parents, or both. Raw scores will converted to scaled scores from zero to 100. Higher scores indicate better health and better quality of life outcome.

    Measured: measured at 0, 9 months and 12 month followup visits

Timeline

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

  1. First posted9 Apr 2018
  2. Study start13 Mar 2014
  3. Primary completion3 Jan 2017
  4. Study completion3 Jan 2017

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
Within-subject design with repeated measures, with random assignment to initial treatment.
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03491657
Sponsor's protocol ID
71011-GAL
Status last verified
Mar 2018
First submitted
10 Mar 2018
Last updated
11 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared with other researchers. Any data shared with other researchers will be in unidentifiable form.

Publications

  • Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.

    PubMed 21264690

  • Crombez G, Bijttebier P, Eccleston C, Mascagni T, Mertens G, Goubert L, Verstraeten K. The child version of the pain catastrophizing scale (PCS-C): a preliminary validation. Pain. 2003 Aug;104(3):639-646. doi: 10.1016/S0304-3959(03)00121-0.

    PubMed 12927636

Questions about this trial

What is this clinical trial studying?

A study testing virtual reality distraction (Yes VR) and music distraction (No VR) in people with Pain, Acute, run by The University of Texas Medical Branch, Galveston 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 11 Jul 2018. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

"Worst Pain" rating of pain intensity during Music vs. during VR (time frame: measured after burn wound care on each study day for up to 10 study days per patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03491657, which also lists 2 linked publications.

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 11 Jul 2018.

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