FOREVR Peds: Virtual Reality and Pain

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04351776
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 47.7
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Pain; Anxiety Postoperative	Other: VR-Biofeedback; Other: VR-Distraction; Other: 360 Video	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 90 participants assigned to one of three groups (30 participants for each group). VR- Biofeedback, VR-Distraction, 360 Video90 participants assigned to one of three groups (30 participants for each group). VR- Biofeedback, VR-Distraction, 360 Video
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients: a Randomized Clinical Trials
• Actual Study Start Date: Jul 10, 2020
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Secondary Outcome Measures

1. Effect of VR-biofeedback on anxiety [Before 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.

2. 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

3. Effect of VR-biofeedback on medication use [Duration of hospital stay up to 30 days after discharge]

   Medications used will be collected

4. Effect of VR-distraction on anxiety [Before 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

5. 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

6. Effect of VR-distraction on medication use [Duration of hospital stay up to 30 days after discharge]

   Medications used will be collected

7. Effect of 360 video on anxiety [Before 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

8. 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

9. Effect of 360 video on medication use [Duration of hospital stay up to 30 days after discharge]

   Medications used will be collected

10. Role of anxiety on changes in pain [One time prior to study visit]

    Participants will complete a questionnaire regarding anxiety

11. Role of pain catastrophizing [One time prior to study visit]

    Participants will complete a questionnaire regarding pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT04351776
• Other Study ID Numbers: 2019-1090
• First Posted: Apr 17, 2020
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Jul 19, 2022