Virtual Reality for Appendectomy Pain

Not Applicable

Completed

• Conditions: Pain, Postoperative; Appendix Rupture; Pain

• Registration Number: NCT04357132
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-22
• Study Start: 2020-07-12
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of VR-biofeedback on pain	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	24-90 hours	Amount of pain medications used will be collected
Effect of VR-distraction on medication use	24-90 hours	Pain medications used will be collected
Effect of VR-distraction on pain	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 on VR-biofeedback on anxiety	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.
Effect of VR-distraction on anxiety	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States