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OpenTrials
Completed

NCT Number: NCT04351776

Virtual Reality and Pain

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.

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Key information

Conditions

Pain, Postoperative Anxiety Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR-Biofeedback

Other

Participants will be instructed to use the Mindful Aurora application

VR-Distraction

Other

Participants will be instructed to use one of three applications

360 Video

Other

Participants will be instructed which video to view

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Acronym: FOREVR Peds

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2020
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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