A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Procedural Sedation
- Sponsor
- University of British Columbia
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Change in Blood Pressure as measured by blood pressure monitor
- Last Updated
- 7 years ago
Overview
Brief Summary
Children often need procedural sedation in the emergency department during painful procedures (such as reducing fractures).
Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain. VR may also reduce anxiety during sedation induction by reducing providing an alternative stimulus.
This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while undergoing procedural sedation. Investigators will measure heart rate, blood pressure, satisfaction (child, parent, provider), amount of sedatives used and compare between the two groups.
Investigators
Ran Goldman
Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital
University of British Columbia
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Blood Pressure as measured by blood pressure monitor
Time Frame: During the procedure at 1 minute intervals
The blood pressure monitor will display participant blood pressure. Blood pressure will be recorded at 1 minute intervals. The difference in blood pressure from recommended mean blood pressure (systolic and diastolic) based on age will be calculated and compared between groups.
Change in Heart Rate as measured by heart rate monitor
Time Frame: During the procedure at 1 minute intervals
The heart rate monitor will consistently display participant heart rate. Heart rate will be recorded at 1 minute intervals. The difference in heart rate from recommended mean heart rate based on age will be calculated and compared between groups.
Secondary Outcomes
- Satisfaction among Guardians by global rating scale(Immediately after the procedure)
- Time difference of the procedure(Intraoperative)
- Satisfaction among Children by global rating scale(Immediately after the procedure)
- Satisfaction among Emergency Staff by global rating scale(Immediately after the procedure)
- Emergence Phenomenon as measured by yes/no questions regarding participant experience.(Immediately after the procedure and by phone the next day)
- Type and dose of medication(Intraoperative)
- Length of stay in the Emergency Department(Intraoperative)