PainNCT04544631
VR for Pediatric Burn Dressing Changes
A study testing Virtual reality game as adjunctive pain management tool in people with Pain and Burns, run by Nationwide Children's Hospital.
Trial summary
This study evaluated a smart phone virtual reality (VR) to manage pediatric burn dressing pain. A randomized controlled trial was conducted among 90 patients (6-17 years). Active VR participants played the game, passive VR group were immersed in the same VR without interactions, and a standard care group served as the… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- What is being tested?
- Virtual reality game as adjunctive pain management tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 3 Mar 2019
- 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
- children age 6-17 years (inclusive)
- admitted or seen in the outpatient clinic for a burn injury
- spoke English as primary language
Who cannot join
- a severe burn on the face or head that prevented the utilization of the VR
- cognitive or motor impairment that prevented valid administration of study measures
- visual or hearing impairments that prevented interaction with the VR environment
- did not have a legal guardian present to give consent
About this study
Official title: Active and Passive Virtual Reality Distraction for Pain Management During Pediatric Burn Dressing Changes
This study evaluated a smart phone virtual reality (VR) to manage pediatric burn dressing pain. A randomized controlled trial was conducted among 90 patients (6-17 years). Active VR participants played the game, passive VR group were immersed in the same VR without interactions, and a standard care group served as the control. One researcher administered VR and observed pain while another researcher administered post-trial survey that measured child's perceived pain and VR experience. Nurses were asked to report the clinical utility.
- Being tested
- Virtual reality game as adjunctive pain management tool
- Keywords
- Pediatrics, Burns, Pain, Virtual Reality
- Medical subject headings
- Pain, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality game as adjunctive pain management toolOther
A smart phone virtual reality-based pain alleviation tool (VR-PAT).
| Study group | Role | What they receive |
|---|---|---|
| Active VR | Experimental | Participants in the active VR group played a virtual reality game entitled "Virtual River Cruise". In this game, an otter floats down a river on a boat and players activate snow-blowing statues along the shore by focusing on them. The statues will emit snow if they are correctly aimed at by the child, and a thermometer placed in the front of the boat shows decreased temperatures as more snowflakes are blown. As feedback to reinforce continued engagement, a scoreboard placed beside the thermometer will show children the number of statues he/she has activated. Additionally, as the temperature drops, snow and ice will start piling up on the boat and its surroundings, providing an enhanced "cooling" experience for pediatric burn patients. Children interact with the immersive virtual reality environment by tilting their head, minimizing potential interference with the dressing change procedure. Receives: Other: Virtual reality game as adjunctive pain management tool |
| Passive VR | Experimental | Participants in the passive VR group were immersed in the same virtual reality environment as the active VR group, without any interactions with the VR game. Receives: Other: Virtual reality game as adjunctive pain management tool |
| Standard Care Control | No intervention | Participants in the standard group received routinely used distraction tools provided in the clinical setting, such as iPads, music, books, and/or talking. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed pain
Researcher observed pain of patient based on the Face Legs Activity Cry and Consolability behavioral pain assessment tool (FLACC-r), using 0,1,2 numerical scale for category of face, legs, activity, cry, and consolability. Total scores range from 0-10 with higher scores indicating more pain.
Measured: During outpatient burn dressing change, on average lasting about 15 minutes.
Patient self-reported pain
Patient-perceived pain using 0-100 scale Visual Analog Scales (VAS), 0(min)-100(max), higher score for worse outcome.
Measured: During outpatient burn dressing change, on average lasting about 15 minutes.
Secondary outcomes (3)
VR experience self-reported by patient and parents
Self-reported virtual reality experience using patient and parent survey questions (5-6 survey items) about their experience in using virtual reality during burn wound care. Questions are a mixture of yes/no and a 100 Visual Analog Scale (VAS) with 0 being "Not at All" and 100 being "Very Much"
Measured: During outpatient burn dressing change, on average lasting about 15 minutes.
Simulator sickness symptoms of patient
Simulator sickness symptoms using the Simulator Sickness Questionnaire (SSQ), which has 15 survey items with possible choices of "None", "Slight", "Moderate", and "Severe".
Measured: During outpatient burn dressing change, on average lasting about 15 minutes.
Nurse reported feasibility of VR in clinical burn wound care
Attending nurse answered two questions using a survey questionnaire about clinical feasibility of VR using scale ranging from "not at all" to "very easy".
Measured: During outpatient burn dressing change, on average lasting about 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Dec 2016
- Primary completion31 Jan 2019
- Study completion3 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, three-group between subject randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry Xiang, Nationwide Children's Hospital
- Investigators
- Henry Xiang, MD, MPH, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544631
- Sponsor's protocol ID
- IRB16-00444
- Status last verified
- Aug 2024
- First submitted
- 1 Sep 2020
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are confidential patient data so we are not allowed to share the data with other researchers
Publications
Xiang H, Shen J, Wheeler KK, Patterson J, Lever K, Armstrong M, Shi J, Thakkar RK, Groner JI, Noffsinger D, Giles SA, Fabia RB. Efficacy of Smartphone Active and Passive Virtual Reality Distraction vs Standard Care on Burn Pain Among Pediatric Patients: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2112082. doi: 10.1001/jamanetworkopen.2021.12082.
PubMed 34152420Vest E, Armstrong M, Olbrecht VA, Thakkar RK, Fabia RB, Groner JI, Noffsinger D, Tram NK, Xiang H. Association of Pre-procedural Anxiety With Procedure-Related Pain During Outpatient Pediatric Burn Care: A Pilot Study. J Burn Care Res. 2023 May 2;44(3):610-617. doi: 10.1093/jbcr/irac108.
PubMed 35913793Jain S, Armstrong M, Luna J, Thakkar RK, Fabia R, Groner JI, Noffsinger D, Ni A, Nelson E, Xiang H. Features of virtual reality impact effectiveness of VR pain alleviation therapeutics in pediatric burn patients: A randomized clinical trial. PLOS Digit Health. 2024 Jan 25;3(1):e0000440. doi: 10.1371/journal.pdig.0000440. eCollection 2024 Jan.
PubMed 38271320Jones K, Armstrong M, Luna J, Thakkar RK, Fabia R, Groner JI, Noffsinger D, Ni A, Griffin B, Xiang H. Age and Sex Differences of Virtual Reality Pain Alleviation Therapeutic During Pediatric Burn Care: A Randomized Clinical Trial. J Med Ext Real. 2024 Jul 24;1(1):163-173. doi: 10.1089/jmxr.2024.0004. eCollection 2024 Jul.
PubMed 39091668
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active and Passive Virtual Reality Distraction for Pain Management During Pediatric Burn Dressing Changes
- ClinicalTrials.gov ID
- NCT04544631
- Acronym / sponsor ID
- IRB16-00444
- Keywords
- Pediatrics, Burns, Pain, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 3 Mar 2019 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated a smart phone virtual reality (VR) to manage pediatric burn dressing pain. A randomized controlled trial was conducted among 90 patients (6-17 years). Active VR participants played the game, passive VR group were immersed in the same VR without interactions, and a standard care group served as the control. One researcher administered VR and observed pain while another researcher administered post-trial survey that measured child's perceived pain and VR experience. Nurses were asked to report the clinical utility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, three-group between subject randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Active VR | Experimental | Other: Virtual reality game as adjunctive pain management toolParticipants in the active VR group played a virtual reality game entitled "Virtual River Cruise". In this game, an otter floats down a river on a boat and players activate snow-blowing statues along the shore by focusing on them. The statues will emit snow if they are correctly aimed at by the child, and a thermometer placed in the front of the boat shows decreased temperatures as more snowflakes are blown. As feedback to reinforce continued engagement, a scoreboard placed beside the thermometer will show children the number of statues he/she has activated. Additionally, as the temperature drops, snow and ice will start piling up on the boat and its surroundings, providing an enhanced "cooling" experience for pediatric burn patients. Children interact with the immersive virtual reality environment by tilting their head, minimizing potential interference with the dressing change procedure. |
| Passive VR | Experimental | Other: Virtual reality game as adjunctive pain management toolParticipants in the passive VR group were immersed in the same virtual reality environment as the active VR group, without any interactions with the VR game. |
| Standard Care Control | No intervention | –Participants in the standard group received routinely used distraction tools provided in the clinical setting, such as iPads, music, books, and/or talking. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children age 6-17 years (inclusive)
- admitted or seen in the outpatient clinic for a burn injury
- spoke English as primary language
Key exclusion criteria (4 listed)
- a severe burn on the face or head that prevented the utilization of the VR
- cognitive or motor impairment that prevented valid administration of study measures
- visual or hearing impairments that prevented interaction with the VR environment
- did not have a legal guardian present to give consent
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 game as adjunctive pain management toolA smart phone virtual reality-based pain alleviation tool (VR-PAT). | Other | Active VR, Passive VR |
Primary outcome
Observed pain
Time frame: During outpatient burn dressing change, on average lasting about 15 minutes.
Researcher observed pain of patient based on the Face Legs Activity Cry and Consolability behavioral pain assessment tool (FLACC-r), using 0,1,2 numerical scale for category of face, legs, activity, cry, and consolability. Total scores range from 0-10 with higher scores indicating more pain.
Patient self-reported pain
Time frame: During outpatient burn dressing change, on average lasting about 15 minutes.
Patient-perceived pain using 0-100 scale Visual Analog Scales (VAS), 0(min)-100(max), higher score for worse outcome.
3 secondary outcomes
VR experience self-reported by patient and parents
Time frame: During outpatient burn dressing change, on average lasting about 15 minutes.
Simulator sickness symptoms of patient
Time frame: During outpatient burn dressing change, on average lasting about 15 minutes.
Nurse reported feasibility of VR in clinical burn wound care
Time frame: During outpatient burn dressing change, on average lasting about 15 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Results publication: PubMed 34152420Xiang H, Shen J, Wheeler KK, Patterson J, Lever K, Armstrong M, Shi J, Thakkar RK, Groner JI, Noffsinger D, Giles SA, Fabia RB. Efficacy of Smartphone Active and Passive Virtual Reality Distraction vs Standard Care on Burn Pain Among Pediatric Patients: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2112082. doi: 10.1001/jamanetworkopen.2021.12082.
- Results publication: PubMed 35913793Vest E, Armstrong M, Olbrecht VA, Thakkar RK, Fabia RB, Groner JI, Noffsinger D, Tram NK, Xiang H. Association of Pre-procedural Anxiety With Procedure-Related Pain During Outpatient Pediatric Burn Care: A Pilot Study. J Burn Care Res. 2023 May 2;44(3):610-617. doi: 10.1093/jbcr/irac108.
- Results publication: PubMed 38271320Jain S, Armstrong M, Luna J, Thakkar RK, Fabia R, Groner JI, Noffsinger D, Ni A, Nelson E, Xiang H. Features of virtual reality impact effectiveness of VR pain alleviation therapeutics in pediatric burn patients: A randomized clinical trial. PLOS Digit Health. 2024 Jan 25;3(1):e0000440. doi: 10.1371/journal.pdig.0000440. eCollection 2024 Jan.
- Results publication: PubMed 39091668Jones K, Armstrong M, Luna J, Thakkar RK, Fabia R, Groner JI, Noffsinger D, Ni A, Griffin B, Xiang H. Age and Sex Differences of Virtual Reality Pain Alleviation Therapeutic During Pediatric Burn Care: A Randomized Clinical Trial. J Med Ext Real. 2024 Jul 24;1(1):163-173. doi: 10.1089/jmxr.2024.0004. eCollection 2024 Jul.
- Individual participant dataSharing planned: No. IPD are confidential patient data so we are not allowed to share the data with other researchers
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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.
Henry Xiang, MD, MPH, PhD principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality game as adjunctive pain management tool in people with Pain and Burns, run by Nationwide Children's Hospital.
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 3 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: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Observed pain (time frame: During outpatient burn dressing change, on average lasting about 15 minutes.). The study lists 2 primary outcomes in all. 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 NCT04544631, which also lists 4 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 23 Aug 2024.