Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2020-07-10
2023-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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VR-Biofeedback
VR-Biofeedback
Participants will be instructed to use the Mindful Aurora application
VR-Distraction
VR-Distraction
Participants will be instructed to use one of three applications
360 Video
360 Video
Participants will be instructed which video to view
Interventions
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VR-Biofeedback
Participants will be instructed to use the Mindful Aurora application
VR-Distraction
Participants will be instructed to use one of three applications
360 Video
Participants will be instructed which video to view
Eligibility Criteria
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Inclusion Criteria
* Able to read, understand and speak English
* Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service
Exclusion Criteria
* History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
* History of vertigo, dizziness, and/or seizure disorder
* Conditions that would preclude the application of the VR headset, such as surgeries of the head and neck
8 Years
18 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Charlotte Walter, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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References
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Olbrecht VA, Williams SE, O'Conor KT, Boehmer CO, Marchant GW, Glynn SM, Geisler KJ, Ding L, Yang G, King CD. Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). BMJ Open. 2020 Dec 30;10(12):e040295. doi: 10.1136/bmjopen-2020-040295.
Other Identifiers
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2019-1090
Identifier Type: -
Identifier Source: org_study_id
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