Virtual Reality and Pain

Overview

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.

Full Title of Study: “Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients: a Randomized Clinical Trials”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2023

Interventions

  • Other: VR-Biofeedback
    • Participants will be instructed to use the Mindful Aurora application
  • Other: VR-Distraction
    • Participants will be instructed to use one of three applications
  • Other: 360 Video
    • Participants will be instructed which video to view

Arms, Groups and Cohorts

  • Other: VR-Biofeedback
  • Other: VR-Distraction
  • Other: 360 Video

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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
  • 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.
  • Effect of VR-biofeedback on medication use
    • Time Frame: Duration of hospital stay up to 30 days after discharge
    • Medications used will be collected
  • Effect of VR-distraction on anxiety
    • Time Frame: Before 10 minute VR sesssion.
    • 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
    • Time Frame: After 10 minute VR sesssion.
    • 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 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.
  • Effect of VR-distraction on medication use
    • Time Frame: Duration of hospital stay up to 30 days after discharge
    • Medications used will be collected
  • 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
  • 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
  • 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.
  • Effect of 360 video on medication use
    • Time Frame: Duration of hospital stay up to 30 days after discharge
    • Medications used will be collected

Secondary Measures

  • Role of anxiety on changes in pain
    • Time Frame: One time prior to study visit
    • Participants will complete a questionnaire regarding anxiety
  • Role of pain catastrophizing
    • Time Frame: One time prior to study visit
    • Participants will complete a questionnaire regarding pain

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital Medical Center, Cincinnati
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vanessa Olbrecht, MD, Principal Investigator, Children’s Hospital Medical Center, Cincinnati
  • Overall Contact(s)
    • Vanessa Olbrecht, MD, 513-636-4408, vanessa.olbrecht@cchmc.org

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