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OpenTrials
Completed

NCT Number: NCT04556747

FOREVR Peds VR Pilot

To determine the feasibility and acceptability of using immersive virtual reality technologies to impact clinical outcomes (e.g., pain and anxiety) and medication utilization (e.g., narcotics) in pediatric patients with acute and chronic pain.

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Key information

Conditions

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

Age range

7 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Childrens 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 7to 21 years
  • Able to read, understand, and speak English
  • Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service (acute postoperative pain cohort); patients presenting in Same Day Surgery for peripheral IV placement or patients in the CBDI clinic presenting for peripheral IV placement or Port accessing (vascular access cohort); or patients admitted to CCHMC on the Medical Pain Service (chronic pain cohort), or sickle cell patients not on the MPS list.
  • Patients who have undergone bone marrow transplantation or receiving chemotherapy experiencing pain from mucositis

Exclusion criteria

  • Outside the age range (< 7 or > 21 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 glasses, such as surgeries of the head and neck

Treatment and study plan

VR - Distraction

Other

Participants will be instructed to use any application.

VR - Biofeedback

Other

Participants will be instructed to use the Mindful Aurora application.

Primary outcomes

  1. Effect of VR-distraction on anxiety

    Time frame: Before 10 minute VR session.

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety

  2. Effect of VR-Distraction on anxiety

    Time frame: Immediately after 10 minute VR session.

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety

  3. Effect of VR-Distraction on anxiety

    Time frame: 15 minutes after 10 minute VR session.

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety

  4. Effect of VR-Distraction on anxiety

    Time frame: 30 minutes after 10 minute VR session.

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety

  5. Effect of VR-Distraction on pain

    Time frame: Before 10 minute VR session.

    Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain

  6. Effect of VR-Distraction on pain

    Time frame: Immediately after 10 minute VR session.

    Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain

  7. Effect of VR-Distraction on pain

    Time frame: 15 minutes after 10 minute VR session.

    Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain

  8. Effect of VR-Distraction on pain

    Time frame: 30 minutes after 10 minute VR session.

    Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain

  9. Effect of VR-Biofeedback on anxiety

    Time frame: Before 10 minute VR session.

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety

  10. Effect of VR-Biofeedback on anxiety

    Time frame: Immediately after 10 minute VR session.

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety

  11. Effect of VR-Biofeedback on anxiety

    Time frame: 15 minutes after 10 minute VR session.

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety

  12. Effect of VR-Biofeedback on anxiety

    Time frame: 30 minutes after 10 minute VR session.

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety

  13. Effect of VR-Biofeedback on pain

    Time frame: Before 10 minute VR session

    Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain

  14. Effect of VR-Biofeedback on pain

    Time frame: Immediately after 10 minute VR session

    Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain

  15. Effect of VR-Biofeedback on pain

    Time frame: 15 minutes after 10 minute VR session

    Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain

  16. Effect of VR-Biofeedback on pain

    Time frame: 30 minutes after 10 minute VR session

    Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain

Secondary outcomes

  1. Role of anxiety on changes in pain

    Time frame: One time prior to study visit

    Participants will complete a questionnaire regarding anxiety

  2. 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 (FOREVR Peds Study)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2020
Registry last updated
Sep 24, 2021

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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