Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
- Conditions
- Procedural Sedation
- Interventions
- Device: Virtual Reality
- Registration Number
- NCT03692390
- Lead Sponsor
- University of British Columbia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Reality Virtual Reality Participants are distracted by wearing the virtual reality headset and watching a roller coaster app while undergoing procedural sedation
- Primary Outcome Measures
Name Time Method Change in Blood Pressure as measured by blood pressure monitor 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 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 Outcome Measures
Name Time Method Satisfaction among Guardians by global rating scale Immediately after the procedure Guardians will be asked "On a scale of 0-10, how did the procedure go?" A score of 0 represents not very well and a score of 10 represents very well.
Time difference of the procedure Intraoperative Time the procedure takes to complete with or without VR will be recorded to determine if there is any difference.
Satisfaction among Children by global rating scale Immediately after the procedure Children will be asked "On a scale of 0-10, how did the procedure go?" A score of 0 represents not very well and a score of 10 represents very well.
Satisfaction among Emergency Staff by global rating scale Immediately after the procedure Emergency Staff will be asked "How satisfied are you with how the procedure went?" A score of 0 represents not very well and a score of 10 represents very well.
Emergence Phenomenon as measured by yes/no questions regarding participant experience. Immediately after the procedure and by phone the next day Patients will be asked whether they experienced nightmares, day-dreaming, or feeling unwell. Number of patients who experienced these negative emergence phenomenon will be tabulated and compared across groups.
Type and dose of medication Intraoperative Amount of medication and what medications were used will be gathered from the nursing notes.
Length of stay in the Emergency Department Intraoperative Length of stay in the Emergency Department will also be recorded. This will be determined by the intake time noted by triage and the discharge time as witnessed by research assistant or, if unseen, by the time noted on the discharge paperwork.
Trial Locations
- Locations (1)
BC Children's Hospital
🇨🇦Vancouver, British Columbia, Canada