Virtual Reality and Pain

Not Applicable

Completed

• Conditions: Pain, Postoperative; Pain; Anxiety Postoperative
• Interventions: Other: VR-Biofeedback; Other: VR-Distraction; Other: 360 Video

• Registration Number: NCT04351776
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-17
• Study Start: 2020-07-10
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR-Biofeedback	VR-Biofeedback	-
VR-Distraction	VR-Distraction	-
360 Video	360 Video	-

Primary Outcome Measures

Name	Time	Method
Effect of VR-biofeedback on pain	Postoperatively 24 - 90 hours.	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.
Effect of 360 video on pain	Postoperatively 24 - 90 hours.	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.
Effect of VR-distraction on pain	Postoperatively 24 - 90 hours.	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.

Secondary Outcome Measures

Name	Time	Method
Effect of VR-biofeedback on anxiety	After 10 minute VR session. Anxiety will be rated using a visual analog scale.	Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-distraction on medication use	Duration of hospital stay up to 30 days after discharge	Medications used will be collected
Effect of VR-distraction on anxiety	After 10 minute VR session.	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
Effect of VR-biofeedback on medication use	Duration of hospital stay up to 30 days after discharge	Medications used will be collected
Effect of 360 video on anxiety	After 10 minute VR session.	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
Effect of 360 video on medication use	Duration of hospital stay up to 30 days after discharge	Medications used will be collected
Role of anxiety on changes in pain	One time prior to study visit	Participants will complete a questionnaire regarding anxiety
Role of pain catastrophizing	One time prior to study visit	Participants will complete a questionnaire regarding pain

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States