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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Ran Goldman，University of British Columbia

Tracking Information

First Submitted Date ^ICMJE

September 20, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

September 21, 2018

Estimated Primary Completion Date

September 21, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Supportive Care

Condition ^ICMJE

Intervention ^ICMJE

Device: Virtual Reality
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.

Study Arms

Experimental: Virtual Reality
Participants are distracted by wearing the virtual reality headset and watching a roller coaster app while undergoing procedural sedation
No Intervention: Standard-of-Care
Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 21, 2019

Estimated Primary Completion Date

September 21, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

INCLUSION CRITERIA 1. Children age 6 to 16 years 2. The managing physician determines need for procedural sedation 3. Parents will sign a consent form and children will sign an assent form EXCLUSION CRITERIA 1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, inability to communicate) 2. Triage category 1 (resuscitation) 3. Facial features or injury prohibiting wearing the VR goggles

Sex/Gender

Sexes Eligible for Study:

All

Ages

6 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Canada

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Ran Goldman，University of British Columbia

Study Sponsor ^ICMJE

University of British Columbia

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Ran Goldman, MD University of British Columbia

PRS Account

University of British Columbia

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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