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OpenTrials
Completed

NCT Number: NCT04357132

Virtual Reality for Appendectomy Pain

To determine the impact of VR-Biofeedback and VR-Distraction on pain and medication utilization in children and adolescents undergoing surgery for ruptured appendix.

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Key information

Conditions

Appendix Rupture Neurologic Manifestations Pain Pain, Postoperative 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

  • Age 8 - 18 years
  • Able to read, understand, and speak English
  • Patients in the immediate postoperative period following laparoscopic appendectomy for ruptured appendix

Exclusion criteria

  • Outside of 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 disorders
  • Conditions that would preclude the application of the VR headset, such as craniofacial deformities
  • History of chronic pain, frequent opioid use and/or active cancer therapy

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 four applications

Primary outcomes

  1. Effect on 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 on VR-biofeedback on anxiety

    Time frame: Immediately after 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 on VR-biofeedback on anxiety

    Time frame: 15 minutes after 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 on VR-biofeedback on anxiety

    Time frame: 30 minutes after 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-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.

  6. Effect of VR-biofeedback on medication use

    Time frame: 24-90 hours

    Amount of pain medications used will be collected

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Effect of VR-distraction on medication use

    Time frame: 24-90 hours

    Pain medications used will be collected

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 Response to Immersive Virtual Reality in Pediatric Patients Post-Laparoscopic Appedectomy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 22, 2020
Registry last updated
Feb 8, 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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