Virtual Reality for Appendectomy Pain

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Recruiting

CT.gov ID

NCT04357132

Collaborator

(none)

Enrollment

Location

Arms

28.6

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Appendix Rupture Pain Pain, Postoperative	Other: VR-Biofeedback Other: VR-Distraction	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

60 participants assigned to one of two groups. VR- Distraction and VR-Biofeedback60 participants assigned to one of two groups. VR- Distraction and VR-Biofeedback

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 12, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Other: VR-Biofeedback

Other: VR-Biofeedback

Participants will be instructed to use the Mindful Aurora Application

Other: VR-Distraction

Other: VR-Distraction

Participants will be instructed to use one of four applications

Outcome Measures

Primary Outcome Measures

Effect on VR-biofeedback on anxiety [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.
Effect on VR-biofeedback on anxiety [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.
Effect on VR-biofeedback on anxiety [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.
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-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 anxiety [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.
Effect of VR-distraction on anxiety [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.
Effect of VR-distraction on anxiety [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.
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.
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 of VR-distraction on medication use [24-90 hours]
Pain medications used will be collected

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

Principal Investigator: Vanessa Olbrecht, MD, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT04357132

Other Study ID Numbers:

2020-0258

First Posted:

Apr 22, 2020

Last Update Posted:

Aug 3, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Rupture

Study Results

No Results Posted as of Aug 3, 2021