Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department

Study Overview
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Brief Summary
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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.

Official Title
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A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department

Conditions
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Procedural Sedation

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Children age 6 to 16 years The managing physician determines need for procedural sedation Parents will sign a consent form and children will sign an assent form EXCLUSION CRITERIA Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, inability to communicate) Triage category 1 (resuscitation) Facial features or injury prohibiting wearing the VR goggles

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>Participants are distracted by wearing the virtual reality headset and watching a roller coaster app while undergoing procedural sedation | Device: Virtual Reality<br>* Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.<br>|
| No Intervention: Standard-of-Care<br>Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Heart Rate as measured by heart rate monitor | 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. | During the procedure at 1 minute intervals | 
| Change in Blood Pressure as measured by blood pressure monitor | 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. | During the procedure at 1 minute intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence Phenomenon as measured by yes/no questions regarding participant experience. | 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. | Immediately after the procedure and by phone the next day | 
| Satisfaction among Children by global rating scale | 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. | Immediately after the procedure | 
| Satisfaction among Guardians by global rating scale | 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. | Immediately after the procedure | 
| Satisfaction among Emergency Staff by global rating scale | 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. | Immediately after the procedure | 
| Type and dose of medication | Amount of medication and what medications were used will be gathered from the nursing notes. | Intraoperative | 
| Time difference of the procedure | Time the procedure takes to complete with or without VR will be recorded to determine if there is any difference. | Intraoperative | 
| Length of stay in the Emergency Department | 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. | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Heart Rate, Blood Pressure