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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03692390
Other study ID # H18-01949
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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