Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ohio Department of Public Safety | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-PAT | Experimental | Virtual Reality administered during burn dressing changes |
|
| Control | No Intervention | Dressing changes performed without Virtual Reality (other distraction methods available in the home allowed). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR-PAT | Device | Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment during dressing changes. | 1-10 rating scale (self-reported and caregiver-reported), 1(min)-10(max), with higher score indicating worse outcome. | 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. | 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. | Daily for 15-30 minutes burn dressing change for up to 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Burn-related medications | caregiver-reported name and dosage of medication provided for burn-related pain | Daily for burn dressing change for up to 7 days. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Henry Xiang, MD, MPH, PhD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35982492 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002056 | Burns |
| D059787 | Acute Pain |
| D000073818 | Pain, Procedural |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided