Virtual Reality and Pain (FOREVR Peds)
Primary Purpose
Pain, Postoperative, Pain, Anxiety Postoperative
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR-Biofeedback
VR-Distraction
360 Video
Sponsored by
About this trial
This is an interventional other trial for Pain, Postoperative
Eligibility Criteria
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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
VR-Biofeedback
VR-Distraction
360 Video
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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
Effect of VR-biofeedback on medication use
Medications used will be collected
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
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
Effect of VR-distraction on medication use
Medications used will be collected
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
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
Effect of 360 video on medication use
Medications used will be collected
Role of anxiety on changes in pain
Participants will complete a questionnaire regarding anxiety
Role of pain catastrophizing
Participants will complete a questionnaire regarding pain
Full Information
NCT ID
NCT04351776
First Posted
April 3, 2020
Last Updated
August 30, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT04351776
Brief Title
Virtual Reality and Pain
Acronym
FOREVR Peds
Official Title
Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients: a Randomized Clinical Trials
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain, Anxiety Postoperative
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
90 participants assigned to one of three groups (30 participants for each group). VR- Biofeedback, VR-Distraction, 360 Video
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VR-Biofeedback
Arm Type
Other
Arm Title
VR-Distraction
Arm Type
Other
Arm Title
360 Video
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
VR-Biofeedback
Intervention Description
Participants will be instructed to use the Mindful Aurora application
Intervention Type
Other
Intervention Name(s)
VR-Distraction
Intervention Description
Participants will be instructed to use one of three applications
Intervention Type
Other
Intervention Name(s)
360 Video
Intervention Description
Participants will be instructed which video to view
Primary Outcome Measure Information:
Title
Effect of VR-biofeedback on pain
Description
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.
Time Frame
Postoperatively 24 - 90 hours.
Title
Effect of VR-distraction on pain
Description
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.
Time Frame
Postoperatively 24 - 90 hours.
Title
Effect of 360 video on pain
Description
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.
Time Frame
Postoperatively 24 - 90 hours.
Secondary Outcome Measure Information:
Title
Effect of VR-biofeedback on anxiety
Description
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.
Time Frame
Before 10 minute VR session.
Title
Effect of VR-biofeedback on anxiety
Description
Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Time Frame
After 10 minute VR session. Anxiety will be rated using a visual analog scale.
Title
Effect of VR-biofeedback on medication use
Description
Medications used will be collected
Time Frame
Duration of hospital stay up to 30 days after discharge
Title
Effect of VR-distraction on anxiety
Description
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
Time Frame
Before 10 minute VR session.
Title
Effect of VR-distraction on anxiety
Description
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
Time Frame
After 10 minute VR session.
Title
Effect of VR-distraction on medication use
Description
Medications used will be collected
Time Frame
Duration of hospital stay up to 30 days after discharge
Title
Effect of 360 video on anxiety
Description
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
Time Frame
Before 10 minute VR session.
Title
Effect of 360 video on anxiety
Description
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
Time Frame
After 10 minute VR session.
Title
Effect of 360 video on medication use
Description
Medications used will be collected
Time Frame
Duration of hospital stay up to 30 days after discharge
Title
Role of anxiety on changes in pain
Description
Participants will complete a questionnaire regarding anxiety
Time Frame
One time prior to study visit
Title
Role of pain catastrophizing
Description
Participants will complete a questionnaire regarding pain
Time Frame
One time prior to study visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Walter, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33380482
Citation
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.
Results Reference
derived
Learn more about this trial
Virtual Reality and Pain
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