Virtual Reality for Appendectomy Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357132
• Other study ID #: 2020-0258
• Status: Completed
• Phase: N/A
• Start date: July 12, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: February 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendix Rupture
• Pain
• Pain, Postoperative
• Rupture

Intervention

Other:
• VR-Biofeedback
Participants will be instructed to use the Mindful Aurora Application
• VR-Distraction
Participants will be instructed to use one of four applications

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on VR-biofeedback on anxiety	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.	Before 10 minute VR session.
Primary	Effect on VR-biofeedback on anxiety	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.	Immediately after VR session.
Primary	Effect on VR-biofeedback on anxiety	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.	15 minutes after VR session.
Primary	Effect on VR-biofeedback on anxiety	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.	30 minutes after VR session.
Primary	Effect of VR-biofeedback on pain	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.	Postoperatively 24 - 90 hours.
Primary	Effect of VR-biofeedback on medication use	Amount of pain medications used will be collected	24-90 hours
Primary	Effect of VR-distraction on anxiety	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.	Before 10 minute VR session.
Primary	Effect of VR-distraction on anxiety	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.	Immediately after 10 minute VR session.
Primary	Effect of VR-distraction on anxiety	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.	15 minutes after 10 minute VR session.
Primary	Effect of VR-distraction on anxiety	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.	30 minutes after 10 minute VR session.
Primary	Effect of VR-distraction on pain	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.	Postoperatively 24 - 90 hours.
Primary	Effect of VR-distraction on medication use	Pain medications used will be collected	24-90 hours
Secondary	Role of anxiety on changes in pain	Participants will complete a questionnaire regarding anxiety	One time prior to study visit
Secondary	Role of pain catastrophizing	Participants will complete a questionnaire regarding pain	One time prior to study visit