Virtual Reality and Pain (FOREVR Peds)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Pain, Postoperative; Anxiety Postoperative
• Intervention / Treatment: Other: VR-Biofeedback; Other: VR-Distraction; Other: 360 Video

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristie Geisler, BS, CCRP; Phone Number: 513-636-3282; Email: kristie.geisler@cchmc.org
• Study Contact Backup: Name: Charlotte Walter, MD; Phone Number: 859-801-9737; Email: charlotte.walter@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: VR-Biofeedback	Other: VR-Biofeedback; Participants will be instructed to use the Mindful Aurora application
Other: VR-Distraction	Other: VR-Distraction; Participants will be instructed to use one of three applications
Other: 360 Video	Other: 360 Video; Participants will be instructed which video to view

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Effect of VR-biofeedback on medication use	Medications used will be collected	Duration of hospital stay up to 30 days after discharge
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.
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.
Effect of VR-distraction on medication use	Medications used will be collected	Duration of hospital stay up to 30 days after discharge
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.
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.
Effect of 360 video on medication use	Medications used will be collected	Duration of hospital stay up to 30 days after discharge
Role of anxiety on changes in pain	Participants will complete a questionnaire regarding anxiety	One time prior to study visit
Role of pain catastrophizing	Participants will complete a questionnaire regarding pain	One time prior to study visit

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Charlotte Walter, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2019-1090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This information will be made available upon request.
• IPD Sharing Time Frame: Data will become available upon publication. All data will be deidentified.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No