Saturday, October 5, 2024 10/5/2024

A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition

Award Number: R01HS029183
ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY
OPDIV: AHRQ
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Pain management is a top priority during pediatric burn dressing changes. Although virtual reality (VR) for pain management during burn care has been studied in clinical trials for more than 2 decades, there is still no evidence of the effectiveness of smartphone VR for pain management during the care transition from medical settings to at-home burn care. This study’s long-term goal is to use innovative, patient-centric smartphone VR to improve patient experience and outcomes. Based on our published findings that our innovative VR Pain Alleviation Tool (VR-PAT) could result in a clinically meaningful reduction in pain (47.1% overall pain reduction) among 90 pediatric burn patients treated at our hospital outpatient clinic, the overall objectives are to (i) determine VR-PAT effectiveness for pain management and opioid medication use reduction during at-home burn care, and (ii) to identify potential facilitators and barriers that could affect wide use of VR-PAT. The central hypothesis is that VR-PAT can induce clinically meaningful pain reduction (>30%) during repeated at-home burn dressing changes. The rationale is that a determination of the VR-PAT effectiveness at reducing pain and opioid medication use, safety, and patient/family engagement is likely to offer a strong scientific framework by which a smartphone VR can be implemented widely and easily by families at-home. Two specific aims : 1) Evaluate effectiveness of VR- PAT for pain management and opioid pain medication reduction during at-home burn care; 2) Examine continuous engagement of patients and caregivers with VR-PAT during repeated at-home burn dressing changes. A two-group randomized clinical trial will be implemented among a total of 200 pediatric burn patients (6-17 years old). Patients and caregivers from both the intervention group (VR-PAT) and control group (standard care) will complete their daily burn dressing changes at home. Overall pain and worst pain will be measured using a standardized pain Visual Analogue Scale (VAS) during each burn dressing change for 1 week. Area under the curve for child reported overall pain (AUC-VAS) and morphine equivalent total dose of pain medications (AUC-OC) will be integrated to calculate composite pain score intensity and opioid consumption (PIOC) score as the primary outcome for Aim 1. For Aim 2, adverse events, VR experience and engagement will be measured in the VR group to specifically address challenges in designing mHealth interventions that the U.S. National Academy of Medicine (NAM) identified as needing more research. This project is innovative because it not only tests an innovative smartphone VR to optimize patient’s experience and outcomes during at- home care but will also develop a novel composite pain assessment statistical method for broader burn research. The proposed research is significant because it is expected to provide strong scientific as well as practical justifications for implementing smartphone VR for pain management during at-home burn care. Ultimately, such knowledge has the potential of offering smartphone VR as an effective and safe non-pharmaceutical pain management approach during care transition from medical settings to at-home care by family caregivers.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $365,884 )
2024	2024	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Research on Healthcare Costs, Quality and Outcomes	000	3	7/25/2024	NON-COMPETING CONTINUATION	$365,884
														Subtotal = $365,884

Issue Date FY: 2023 ( Subtotal = $368,045 )
2023	2023	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Research on Healthcare Costs, Quality and Outcomes	001	2	7/27/2023	NON-COMPETING CONTINUATION	$368,045
2023	2022	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Research on Healthcare Costs, Quality and Outcomes	000	1	1/23/2023	NEW	$0
														Subtotal = $368,045

Issue Date FY: 2022 ( Subtotal = $399,999 )
2022	2022	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Research on Healthcare Costs, Quality and Outcomes	000	1	9/22/2022	NEW	$399,999
														Subtotal = $399,999

Grand Total All Awards = $1,133,928

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A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition

Award Number: R01HS029183

ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY

OPDIV: AHRQ

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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