Virtual Reality for Appendectomy Pain (NCT04357132) | Clinical Trial Compass
CompletedNot Applicable
Virtual Reality for Appendectomy Pain
United States15 participantsStarted 2020-07-12
Plain-language 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.
Who can participate
Age range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect on VR-biofeedback on anxiety
Timeframe: Before 10 minute VR session.
2
Effect on VR-biofeedback on anxiety
Timeframe: Immediately after VR session.
3
Effect on VR-biofeedback on anxiety
Timeframe: 15 minutes after VR session.
4
Effect on VR-biofeedback on anxiety
Timeframe: 30 minutes after VR session.
5
Effect of VR-biofeedback on pain
Timeframe: Postoperatively 24 - 90 hours.
6
Effect of VR-biofeedback on medication use
Timeframe: 24-90 hours
7
Effect of VR-distraction on anxiety
Timeframe: Before 10 minute VR session.
8
Effect of VR-distraction on anxiety
Trial details
NCT IDNCT04357132
SponsorChildren's Hospital Medical Center, Cincinnati