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

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

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.

Study Overview

• Status: Unknown
• Conditions: Procedural Sedation
• Intervention / Treatment: Device: Virtual Reality

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • Recruiting
      • BC Children's Hospital
      • Contact: Ran D Goldman, MD; Phone Number: 7333 (604) 875-2346; Email: rgoldman@bc.cw.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Ran Goldman, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Anticipated): September 21, 2019
• Study Completion (Anticipated): September 21, 2019

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 30, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 30, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Virtual Reality; Blood Pressure; Heart Rate
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: H18-01949

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No