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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety Postoperative
• Pain
• Pain, Postoperative

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