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Feasibility and acceptability of biofeedback-based virtual reality for postoperative pain management in children and adolescents

Award Number: R34AT011218
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2021
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Feasibility and acceptability of biofeedback-based virtual reality for postoperative pain management in children and adolescents - PROJECT SUMMARY Mind-body therapies, like biofeedback (BF), are effective treatments to decrease pain in children and adults. While decades of literature support the use of BF to decrease pain, BF is not currently available for use in the postoperative period as it is a resource-rich intervention. With the help of novel technologic innovations, like virtual reality (VR), BF can be delivered in an engaging, less resource-intensive manner, resulting in a more accessible therapy that can be applied in broader clinical settings. VR has also demonstrated efficacy to decrease pain, but transient reductions in pain due to the redirection of attention are insufficient to treat prolonged acute pain experiences. FOREVR VR (Functional Outcome Response to Engaging VR) is a first-of- its-kind, VR-based BF intervention and delivery system. Combining VR and BF (VR-BF) synergizes the immersion and entertainment of VR with the physiological modifications of BF to enhance and sustain each modality’s therapeutic effects. VR-BF is an engaging and motivating therapy that children can perform independently and that has shown efficacy in treating several disorders. Despite early evidence of efficacy, VR-BF is a new therapy and has not yet been employed in perioperative care, thus no optimal duration and frequency or defined treatment protocols for preoperative training and postoperative application of VR-BF exist. This study marks the first to assess the implementation and use of VR-BF in the perioperative setting and seeks to establish measurable milestones that have not been addressed in prior studies. The goal of this two- phase study is to understand how to implement a novel VR-BF therapy for postoperative pain management in children. Before conducting an efficacy trial of VR-BF versus active control, it is imperative to assess factors that will impact the VR-BF intervention and, consequently, the efficacy of VR-BF to reduce pain and opioid use. Our central hypothesis is that the use of VR-BF in pediatric patients undergoing surgery resulting in moderate to severe pain will be feasible and acceptable, and that findings from this pilot trial will inform design of a large- scale efficacy trial of VR-BF in this patient population. Specific aims: (1) Refine a treatment protocol for preoperative education and training and postoperative application of VR-BF using FOREVR VR in children and adolescents undergoing surgery; and (2) Conduct a pilot randomized controlled trial to assess the feasibility and acceptability of perioperative use of VR-BF using FOREVR VR in children and adolescents undergoing surgery. The multidisciplinary research team, a unique collaboration of an anesthesiologist, pain experts, clinical psychologists, a biostatistician, and a clinical trial design expert; are ideally suited to accomplish these research goals. Data from this R34 will inform design of a large-scale, randomized, clinical efficacy trial using VR-BF to assess pain and opioid reduction in children and adolescents with acute postoperative pain. It will provide insight on preoperative education and training and postoperative application of VR-BF, in efforts to improve postoperative analgesia, reduce opioid and analgesic use, and assist in pain and stress management.


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: 2026 ( Subtotal = $0 )
2026	2023	THE NEMOURS FOUNDATION	1600 ROCKLAND RD	WILMINGTON	DE	19803	NEW CASTLE	USA	Research and Training in Complementary and Integrative Health	000	4	12/10/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Research and Training in Complementary and Integrative Health	000	3	1/15/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = -$2,790 )
2024	2023	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Research and Training in Complementary and Integrative Health	000	3	10/19/2023	NON-COMPETING CONTINUATION	$0
2024	2023	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Research and Training in Complementary and Integrative Health	001	3	6/25/2024	NON-COMPETING CONTINUATION	-$143,244
2024	2023	THE NEMOURS FOUNDATION	1600 ROCKLAND RD	WILMINGTON	DE	19803	NEW CASTLE	USA	Research and Training in Complementary and Integrative Health	002	4	6/25/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$140,454
														Subtotal = -$2,790

Issue Date FY: 2023 ( Subtotal = $227,477 )
2023	2023	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Research and Training in Complementary and Integrative Health	000	3	7/10/2023	NON-COMPETING CONTINUATION	$227,477
														Subtotal = $227,477

Issue Date FY: 2022 ( Subtotal = $232,545 )
2022	2022	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Research and Training in Complementary and Integrative Health	000	2	6/27/2022	NON-COMPETING CONTINUATION	$232,545
														Subtotal = $232,545

Issue Date FY: 2021 ( Subtotal = $241,380 )
2021	2021	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Research and Training in Complementary and Integrative Health	000	1	9/13/2021	NEW	$241,380
														Subtotal = $241,380

Grand Total All Awards = $698,612

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Feasibility and acceptability of biofeedback-based virtual reality for postoperative pain management in children and adolescents

Award Number: R34AT011218

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/15/2021

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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