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Virtual Reality and Pain (FOREVR Peds)

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ClinicalTrials.gov Identifier: NCT04351776
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : July 10, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
VR-Biofeedback Other: VR-Biofeedback
Participants will be instructed to use the Mindful Aurora application
VR-Distraction Other: VR-Distraction
Participants will be instructed to use one of three applications
360 Video Other: 360 Video
Participants will be instructed which video to view


Outcome Measures
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Primary Outcome Measures :
  1. Effect of VR-biofeedback on pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Duration of hospital stay up to 30 days after discharge ]
    Medications used will be collected

  4. Effect of VR-distraction on anxiety [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Duration of hospital stay up to 30 days after discharge ]
    Medications used will be collected

  7. Effect of 360 video on anxiety [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Duration of hospital stay up to 30 days after discharge ]
    Medications used will be collected

  10. Role of anxiety on changes in pain [ Time Frame: One time prior to study visit ]
    Participants will complete a questionnaire regarding anxiety

  11. Role of pain catastrophizing [ Time Frame: One time prior to study visit ]
    Participants will complete a questionnaire regarding pain


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351776


Contacts
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Contact: Charlotte Walter, MD 859-801-9737 charlotte.walter@cchmc.org
Contact: Kristie Geisler, BS, CCRP 513-636-3282 kristie.geisler@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Charlotte Walter, MD    859-801-9737    charlotte.walter@cchmc.org   
Contact: Kristie Geisler, BS, CCRP    513-636-3282    kristie.geisler@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Charlotte Walter, MD Children's Hospital Medical Center, Cincinnati
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04351776    
Other Study ID Numbers: 2019-1090
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This information will be made available upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will become available upon publication. All data will be deidentified.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations