Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain
Feasibility and Acceptability of a Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain in Children and Adolescents After Surgery
2 other identifiers
interventional
93
1 country
1
Brief Summary
To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Mar 2022
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
June 29, 2021
CompletedStudy Start
First participant enrolled
March 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2025
CompletedSeptember 15, 2025
September 1, 2025
3.4 years
May 17, 2021
September 12, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Aim 1: Treatment protocol refinement
Frequency of sessions
Duration of study up to 30 days
Aim 1: Treatment protocol refinement
Duration of sessions
Duration of study up to 30 days
Aim 2: Feasibility of technology intervention in perioperative patients
Rate of study recruitment
Pre-intervention
Secondary Outcomes (18)
Aim 1: Preoperative training protocol
Up to two weeks pre-operatively
Aim 1: Preoperative training protocol
Up to two weeks pre-operatively
Aim 1: Post-operative session protocol
Up to two week post surgery
Aim 1: Post-operative session protocol
Up to two weeks post surgery
Aim 2: Rate of study enrollment/randomization
Pre-intervention
- +13 more secondary outcomes
Study Arms (3)
Technology Based Intervention 1 (Phase 1)
OTHERTechnology Based Intervention 1 (Phase 2)
OTHERTechnology Based Intervention 2 (Phase 2)
OTHERInterventions
In Phase 1, all participants will use the same technology. In Phase 2, participants will be blinded to the two specific groups. They will not be aware of the technology used in the group they are not assigned too.
Participants will be blinded to the two specific groups. They will not be aware of the technology used in the group they are not assigned too.
Eligibility Criteria
You may qualify if:
- Ages 12 -18 years
- Scheduled to undergo surgery anticipated to cause moderate to severe pain with expected length of stay \> or = to 2 days
- Able to read, understand and speak English
- Patients requiring management by the Acute Pain Service
- Possession of a mobile device/computer available for study participation
You may not qualify if:
- Outside the age range (\< 12 or \> 18 years)
- Non-English speaking
- History of significant developmental delay, uncontrolled psychiatric conditions associated with hallucinations or delusions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
- History of vertigo, dizziness, seizure disorder, and/or severe motion sickness
- History of chronic pain
- Are chronically using opioids and or benzodiazepines for the management of pain
- Are actively experiencing nausea or vomiting
- Conditions such as craniofacial abnormalities or surgeries of the head and neck
- Previous participation in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nemours Children's Hospital
Wilmington, Delaware, 19803, United States
Related Publications (2)
Orgil Z, Karthic A, Bell NF, Heisterberg LM, Williams SE, Ding L, Kashikar-Zuck S, King CD, Olbrecht VA. Use of Biofeedback-Based Virtual Reality in Pediatric Perioperative and Postoperative Settings: Observational Study. JMIR Perioper Med. 2024 Sep 16;7:e48959. doi: 10.2196/48959.
PMID: 38742940DERIVEDOrgil Z, Johnson L, Karthic A, Williams SE, Ding L, Kashikar-Zuck S, King CD, Olbrecht VA. Feasibility and acceptability of perioperative application of biofeedback-based virtual reality versus active control for pain and anxiety in children and adolescents undergoing surgery: protocol for a pilot randomised controlled trial. BMJ Open. 2023 Jan 25;13(1):e071274. doi: 10.1136/bmjopen-2022-071274.
PMID: 36697053DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vanessa Olbrecht, MD
Nemours Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chair, Department of Anesthesiology & Perioperative Medicine
Study Record Dates
First Submitted
May 17, 2021
First Posted
June 29, 2021
Study Start
March 10, 2022
Primary Completion
August 6, 2025
Study Completion
August 22, 2025
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
IPD will not be shared with the public, but aggregate data will be publicly available upon request.