BurnsPhase 2/3NCT04548635
VR for Burn Dressing Changes at Home
A Phase 2/3 study testing VR-PAT in people with Burns and Acute Pain, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This study will evaluate the impact of our smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) during the repeated at-home burn dressing changes of children (5-17 years) with a burn injury in comparison with a control group of children with a burn injury who will not use VR-PAT during at-home burn dressing… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Burns, Acute Pain, Procedural Pain
- What is being tested?
- VR-PAT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to 18 Jun 2021
- Phase
- Phase 2/3
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients age 5-17 years (inclusive)
- receiving first outpatient dressing change or being discharged from the inpatient burn unit at our institution
- have a dressing that requires daily changes at home for at least one week
- can communicate orally
Who cannot join
- any wounds that may interfere with study procedures (i.e. face)
- vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
- history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
- minors in foster care
- suspected child abuse
- unable to communicate in English
- families who do not have access to a smartphone (due to the VR-PAT game requirements)
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Mobile Phone Virtual Reality Game for Pediatric Home Burn Dressing Pain Management
This study will evaluate the impact of our smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) during the repeated at-home burn dressing changes of children (5-17 years) with a burn injury in comparison with a control group of children with a burn injury who will not use VR-PAT during at-home burn dressing changes. We hypothesize that children using VR-PAT will report less pain during their dressing changes.
Read the detailed description
Subjects will be randomly assigned to either the VR-PAT intervention group or Control group. Subjects and caregivers in both groups will perform daily dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Subjects and caregivers in the intervention group will answer additional questions about their experience using the VR-PAT, ease of use, and helpfulness. Surveys will be repeated with each dressing changes for one week.
- Conditions
- Burns, Acute Pain, Procedural Pain
- Being tested
- VR-PAT
- Keywords
- Virtual Reality, VR, Burns, Pain, Dressing Changes
- Medical subject headings
- Burns, Acute Pain, Pain, Procedural, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-PATDevice
Also called Virtual Reality
Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset
| Study group | Role | What they receive |
|---|---|---|
| VR-PAT | Experimental | Virtual Reality administered during burn dressing changes Receives: Device: VR-PAT |
| Control | No intervention | Dressing changes performed without Virtual Reality (other distraction methods available in the home allowed). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment during dressing changes.
1-10 rating scale (self-reported and caregiver-reported), 1(min)-10(max), with higher score indicating worse outcome.
Measured: 15-30 minutes during daily burn dressing changes for up to 7 days.
Observed VR experience.
caregiver-reported subject's engagement with VR (VR-PAT arm only) using a 5-item parent questionnaire.
Measured: Daily for 15-30 minutes burn dressing change for up to 7 days.
Self-reported VR experience.
1-10 rating scale of degree of realism, pleasure, and satisfaction with VR (VR-PAT arm only), with higher score meaning better outcome.
Measured: Daily for 15-30 minutes burn dressing change for up to 7 days.
Secondary outcomes (1)
Burn-related medications
caregiver-reported name and dosage of medication provided for burn-related pain
Measured: Daily for burn dressing change for up to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start5 Sep 2019
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio Department of Public Safety
- 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
- NCT04548635
- Sponsor's protocol ID
- STUDY00000450
- Status last verified
- Apr 2024
- First submitted
- 1 Sep 2020
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armstrong M, Lun J, Groner JI, Thakkar RK, Fabia R, Noffsinger D, Ni A, Keesari R, Xiang H. Mobile phone virtual reality game for pediatric home burn dressing pain management: a randomized feasibility clinical trial. Pilot Feasibility Stud. 2022 Aug 18;8(1):186. doi: 10.1186/s40814-022-01150-9.
PubMed 35982492
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone Virtual Reality Game for Pediatric Home Burn Dressing Pain Management
- ClinicalTrials.gov ID
- NCT04548635
- Acronym / sponsor ID
- STUDY00000450
- Conditions
- Burns, Acute Pain, Procedural Pain
- Keywords
- Virtual Reality, VR, Burns, Pain, Dressing Changes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Ohio Department of Public Safety
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 14 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 will evaluate the impact of our smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) during the repeated at-home burn dressing changes of children (5-17 years) with a burn injury in comparison with a control group of children with a burn injury who will not use VR-PAT during at-home burn dressing changes. We hypothesize that children using VR-PAT will report less pain during their dressing changes.
Detailed description
Subjects will be randomly assigned to either the VR-PAT intervention group or Control group. Subjects and caregivers in both groups will perform daily dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Subjects and caregivers in the intervention group will answer additional questions about their experience using the VR-PAT, ease of use, and helpfulness. Surveys will be repeated with each dressing changes for one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-PAT | Experimental | Device: VR-PATVirtual Reality administered during burn dressing changes |
| Control | No intervention | –Dressing changes performed without Virtual Reality (other distraction methods available in the home allowed). |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- pediatric patients age 5-17 years (inclusive)
- receiving first outpatient dressing change or being discharged from the inpatient burn unit at our institution
- have a dressing that requires daily changes at home for at least one week
- can communicate orally
Key exclusion criteria (7 listed)
- any wounds that may interfere with study procedures (i.e. face)
- vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
- history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
- minors in foster care
- suspected child abuse
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 |
|---|---|---|
| VR-PATAlso: Virtual RealitySmartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset | Device | VR-PAT |
Primary outcome
Pain assessment during dressing changes.
Time frame: 15-30 minutes during daily burn dressing changes for up to 7 days.
1-10 rating scale (self-reported and caregiver-reported), 1(min)-10(max), with higher score indicating worse outcome.
Observed VR experience.
Time frame: Daily for 15-30 minutes burn dressing change for up to 7 days.
caregiver-reported subject's engagement with VR (VR-PAT arm only) using a 5-item parent questionnaire.
Self-reported VR experience.
Time frame: Daily for 15-30 minutes burn dressing change for up to 7 days.
1-10 rating scale of degree of realism, pleasure, and satisfaction with VR (VR-PAT arm only), with higher score meaning better outcome.
1 secondary outcome
Burn-related medications
Time frame: Daily for burn dressing change for up to 7 days.
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 30 Apr 2024.
- Results publication: PubMed 35982492Armstrong M, Lun J, Groner JI, Thakkar RK, Fabia R, Noffsinger D, Ni A, Keesari R, Xiang H. Mobile phone virtual reality game for pediatric home burn dressing pain management: a randomized feasibility clinical trial. Pilot Feasibility Stud. 2022 Aug 18;8(1):186. doi: 10.1186/s40814-022-01150-9.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VR-PAT in people with Burns and Acute Pain, run by Nationwide Children's Hospital 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 4 inclusion and 7 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 30 Apr 2024. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain assessment during dressing changes. (time frame: 15-30 minutes during daily burn dressing changes for up to 7 days.). 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?
On the ClinicalTrials.gov record for NCT04548635, 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 30 Apr 2024.