BurnsNCT01812655
Comparison of Virtual Reality and Passive Distraction on Burn Wound Care Pain in Adolescents
A study testing Virtual Reality and Passive Distraction in people with Burns and Wound Care, run by University of Arkansas at 1 site in United States.
Trial summary
Relief of severe burn wound care pain may require both medications to relieve pain and non-medication interventions,such as distraction. Little is known about distraction's effectiveness. Virtual reality may be an effective distraction. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Burns, Wound Care, Pain
- What is being tested?
- Virtual Reality and Passive Distraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- undergoing burn wound care in the Arkansas Children's Hospital (ACH) outpatient burn clinic;
- first time visit to the ACH outpatient burn clinic or first clinic visit without conscious sedation;
- adolescents ages 10 to 17 years;
- English speaking;
- absence of a history of motion sickness (motion sickness has been reported in some VR users);
- absence of a seizure disorder (because prolonged immersion in VR may lead to seizures and vertigo in individuals with seizure disorders, these individuals will be excluded from the study);
- absence of a cognitive developmental disability determined on prescreening by presence of a Section 504 accommodation plan or Title VIII individualized educational plan (IEP) in school. If the parent identifies the nature of the IEP or 504 plan as unrelated to a cognitive delay, then the child or adolescent will be included in the study.
Who cannot join
- Burns that would interfere with study procedures
- Incarcerated minors
- Children in foster care
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
Official title: Comparison of Virtual Reality and Passive Distraction on Burn Wound Care
Relief of severe burn wound care pain may require both medications to relieve pain and non-medication interventions,such as distraction. Little is known about distraction's effectiveness. Virtual reality may be an effective distraction. The aims of this study are 1)to evaluate the effect of virtual reality (VR), a newer interactive kind of distraction, compared to passive distraction (PD) by watching a movie, and usual care (SC) that is provided by the nurses, on pain experienced by adolescents during burn wound care and 2)to determine the relationship among anxiety, desire for distraction, and engagement with distraction on the pain.
- Conditions
- Burns, Wound Care, Pain
- Being tested
- Virtual Reality, Passive Distraction
- Keywords
- pain, anxiety, children, adolescents, burn, virtual reality, distraction
- Medical subject headings
- Burns, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Passive DistractionOther
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Virtual reality using a software program designed for burn patients during burn wound care Receives: Device: Virtual Reality |
| Passive distraction | Active comparator | watching a movie Receives: Other: Passive Distraction |
| UC provided by the nurses | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Wound Care Procedure Pain Score
The acute pain experienced during the burn wound care procedure was measured on a 100mm visual analog scale called the Adolescent Pediatric Pain Tool through self-report by adolescents ages 10-17 years receiving outpatient burn wound care. The scale ranges from 0mm (No Pain) to 100mm (Worst Pain).
Measured: Within the first 20 minutes following completion of the burn wound care procedure
Secondary outcomes (2)
Desire for Distraction
Participants were asked "I wanted to be distracted from during my treatment today." (Agree-Disagree) from the Post-Procedure Questionnaire
Measured: Post-procedure (approximately 30-75 minutes)
Engagement With Distraction and Belief in Distraction's Efficacy
For Engagement with Distraction,VR and PD participants were asked on the Post-testing Questionnaire: "Were you able to pay attention to the DVD or to the VR during your burn treatment?" (1=could not pay attention at all; 5=totally absorbed at all times)
For Belief in Distraction's Efficacy, VR and PD participants were asked on the Post-Procedure Questionnaire: "I believe that the distraction lessened my pain during my burn treatment today." (on a scale of 1=Distraction did not help to lessen my pain at all; 5=Distraction completely helped to lessen my pain at all times)
Measured: Post-procedure (approximately 30-75 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startJun 2010
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Early termination of study due to fewer subjects available than expected resulting in small sample size.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute, Arkansas Biosciences Institute, Arkansas Children's Hospital Burn Center
- Responsible party
- Sponsor
- Investigators
- Debra A Jeffs, PhD, RN, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812655
- Sponsor's protocol ID
- 109422
- Status last verified
- Aug 2013
- First submitted
- 13 Mar 2013
- Last updated
- 6 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Askay SW, Patterson DR. What are the psychiatric sequelae of burn pain? Curr Pain Headache Rep. 2008;12(2):94-97. Das DA, Grimmer KA, Sparnon AL, et al. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial. BMC Pediatr. 2005;5(1):1471-2431. Patterson DR, Weichman SA, Jensen MP, et al. Hypnosis delivered through immersive virtual reality for burn pain: a clinical case series. Int J Clin Exp Hypn. 2006;54(2):130-142. Hoffman HG, Chambers GT, Meyer WJ, et al. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann. Behav. Med. 2011;41(2):183-191. doi: 10.1007/s12160-010-9248-7. Smith JS, Smith KR, Rainey SL. The psychology of burn care. J Trauma Nurs. 2006;13(3):105-106.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Virtual Reality and Passive Distraction on Burn Wound Care
- ClinicalTrials.gov ID
- NCT01812655
- Acronym / sponsor ID
- 109422
- Conditions
- Burns, Wound Care, Pain
- Keywords
- pain, anxiety, children, adolescents, burn, virtual reality, distraction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination of study due to fewer subjects available than expected resulting in small sample size.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute, Arkansas Biosciences Institute, Arkansas Children's Hospital Burn Center
- Study start
- Jun 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Posted 6 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Relief of severe burn wound care pain may require both medications to relieve pain and non-medication interventions,such as distraction. Little is known about distraction's effectiveness. Virtual reality may be an effective distraction. The aims of this study are 1)to evaluate the effect of virtual reality (VR), a newer interactive kind of distraction, compared to passive distraction (PD) by watching a movie, and usual care (SC) that is provided by the nurses, on pain experienced by adolescents during burn wound care and 2)to determine the relationship among anxiety, desire for distraction, and engagement with distraction on the pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual RealityVirtual reality using a software program designed for burn patients during burn wound care |
| Passive distraction | Active comparator | Other: Passive Distractionwatching a movie |
| UC provided by the nurses | No intervention | – |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- undergoing burn wound care in the Arkansas Children's Hospital (ACH) outpatient burn clinic;
- first time visit to the ACH outpatient burn clinic or first clinic visit without conscious sedation;
- adolescents ages 10 to 17 years;
- English speaking;
- absence of a history of motion sickness (motion sickness has been reported in some VR users);
Key exclusion criteria (3 listed)
- Burns that would interfere with study procedures
- Incarcerated minors
- Children in foster care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality | Device | Virtual Reality |
| Passive Distraction | Other | Passive distraction |
Primary outcome
Self-reported Wound Care Procedure Pain Score
Time frame: Within the first 20 minutes following completion of the burn wound care procedure
The acute pain experienced during the burn wound care procedure was measured on a 100mm visual analog scale called the Adolescent Pediatric Pain Tool through self-report by adolescents ages 10-17 years receiving outpatient burn wound care. The scale ranges from 0mm (No Pain) to 100mm (Worst Pain).
2 secondary outcomes
Desire for Distraction
Time frame: Post-procedure (approximately 30-75 minutes)
Engagement With Distraction and Belief in Distraction's Efficacy
Time frame: Post-procedure (approximately 30-75 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAskay SW, Patterson DR. What are the psychiatric sequelae of burn pain? Curr Pain Headache Rep. 2008;12(2):94-97. Das DA, Grimmer KA, Sparnon AL, et al. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial. BMC Pediatr. 2005;5(1):1471-2431. Patterson DR, Weichman SA, Jensen MP, et al. Hypnosis delivered through immersive virtual reality for burn pain: a clinical case series. Int J Clin Exp Hypn. 2006;54(2):130-142. Hoffman HG, Chambers GT, Meyer WJ, et al. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann. Behav. Med. 2011;41(2):183-191. doi: 10.1007/s12160-010-9248-7. Smith JS, Smith KR, Rainey SL. The psychology of burn care. J Trauma Nurs. 2006;13(3):105-106.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra A Jeffs, PhD, RN principal investigator
Arkansas Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Passive Distraction in people with Burns and Wound Care, run by University of Arkansas 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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 6 Aug 2013. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-reported Wound Care Procedure Pain Score (time frame: Within the first 20 minutes following completion of the burn wound care procedure). 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 NCT01812655, which also lists 1 linked publication.
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 6 Aug 2013.