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NCT04351776 Clinical Trial

Virtual Reality and Pain

Pain Clinical Trial

— FOREVR Peds  

Official title:
Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients: a Randomized Clinical Trials

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04351776
Other study ID # 2019-1090
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 10, 2020
Est. completion date July 30, 2023

Study information
Verified date August 2023
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Determine the impact of VR-Biofeedback, VR-distraction, and 360 video on pain and medication utilization in patients undergoing surgery; determine the role of anxiety and pain catastrophizing on changes in pain following VR-BF in patients undergoing surgery.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date July 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers No
Gender All
Age group 8 Years to 18 Years
Eligibility Inclusion Criteria: - Ages 8 - 18 years - 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: - Outside the age range (< 8 or > 18 years) - 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of VR-biofeedback on pain Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. Postoperatively 24 - 90 hours.
Primary Effect of VR-distraction on pain Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. Postoperatively 24 - 90 hours.
Primary Effect of 360 video on pain Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. Postoperatively 24 - 90 hours.
Secondary Effect of VR-biofeedback on anxiety Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety. Before 10 minute VR session.
Secondary Effect of VR-biofeedback on anxiety Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety After 10 minute VR session. Anxiety will be rated using a visual analog scale.
Secondary Effect of VR-biofeedback on medication use Medications used will be collected Duration of hospital stay up to 30 days after discharge
Secondary Effect of VR-distraction on anxiety Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety Before 10 minute VR session.
Secondary Effect of VR-distraction on anxiety Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety After 10 minute VR session.
Secondary Effect of VR-distraction on medication use Medications used will be collected Duration of hospital stay up to 30 days after discharge
Secondary Effect of 360 video on anxiety Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety Before 10 minute VR session.
Secondary Effect of 360 video on anxiety Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety After 10 minute VR session.
Secondary Effect of 360 video on medication use Medications used will be collected Duration of hospital stay up to 30 days after discharge
Secondary Role of anxiety on changes in pain Participants will complete a questionnaire regarding anxiety One time prior to study visit
Secondary Role of pain catastrophizing Participants will complete a questionnaire regarding pain One time prior to study visit
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