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Virtual Reality for Appendectomy Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04357132
Enrollment
15
Registered
2020-04-22
Start date
2020-07-12
Completion date
2021-08-30
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendix Rupture, Pain, Pain, Postoperative

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.

Interventions

Participants will be instructed to use the Mindful Aurora Application

Participants will be instructed to use one of four applications

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of VR-distraction on medication use24-90 hoursPain medications used will be collected
Effect of VR-distraction on anxietyBefore 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 painPostoperatively 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 anxietyBefore 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 of VR-biofeedback on painPostoperatively 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 use24-90 hoursAmount of pain medications used will be collected

Secondary

MeasureTime frameDescription
Role of pain catastrophizingOne time prior to study visitParticipants will complete a questionnaire regarding pain
Role of anxiety on changes in painOne time prior to study visitParticipants will complete a questionnaire regarding anxiety

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026