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

Procedural Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03692390
• Other study ID #: H18-01949
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2018
• Est. completion date: September 21, 2019

Study information

• Verified date: September 2018
• Source: University of British Columbia
• Contact: Ran Goldman, MD
• Phone: 604-875-2345
• Email: rgoldman[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: September 21, 2019
• Est. primary completion date: September 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Procedural Sedation

Intervention

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.

Locations

Country	Name	City	State
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Type and dose of medication	Amount of medication and what medications were used will be gathered from the nursing notes.	Intraoperative
Secondary	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
Secondary	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