Virtual Reality for Appendectomy Pain
Overview
To determine the impact of VR-Biofeedback and VR-Distraction on pain and medication utilization in children and adolescents undergoing surgery for ruptured appendix.
Full Title of Study: “Functional Response to Immersive Virtual Reality in Pediatric Patients Post-Laparoscopic Appedectomy”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: August 30, 2021
Interventions
- Other: VR-Biofeedback
- Participants will be instructed to use the Mindful Aurora Application
- Other: VR-Distraction
- Participants will be instructed to use one of four applications
Arms, Groups and Cohorts
- Other: VR-Biofeedback
- Other: VR-Distraction
Clinical Trial Outcome Measures
Primary Measures
- Effect on VR-biofeedback on anxiety
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 24-90 hours
- Amount of pain medications used will be collected
- Effect of VR-distraction on anxiety
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 24-90 hours
- Pain medications used will be collected
Secondary Measures
- Role of anxiety on changes in pain
- Time Frame: One time prior to study visit
- Participants will complete a questionnaire regarding anxiety
- Role of pain catastrophizing
- Time Frame: One time prior to study visit
- Participants will complete a questionnaire regarding pain
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 8 Years
Maximum Age: 18 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Children’s Hospital Medical Center, Cincinnati
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Vanessa Olbrecht, MD, Principal Investigator, Children’s Hospital Medical Center, Cincinnati
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