Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
Primary Purpose
Procedural Sedation
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
About this trial
This is an interventional supportive care trial for Procedural Sedation focused on measuring Virtual Reality, Heart Rate, Blood Pressure
Eligibility Criteria
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
Sites / Locations
- BC Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual Reality
Standard-of-Care
Arm Description
Participants are distracted by wearing the virtual reality headset and watching a roller coaster app while undergoing procedural sedation
Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Type and dose of medication
Amount of medication and what medications were used will be gathered from the nursing notes.
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.
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.
Full Information
NCT ID
NCT03692390
First Posted
September 20, 2018
Last Updated
September 30, 2018
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT03692390
Brief Title
Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
Official Title
A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2018 (Actual)
Primary Completion Date
September 21, 2019 (Anticipated)
Study Completion Date
September 21, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Sedation
Keywords
Virtual Reality, Heart Rate, Blood Pressure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Participants are distracted by wearing the virtual reality headset and watching a roller coaster app while undergoing procedural sedation
Arm Title
Standard-of-Care
Arm Type
No Intervention
Arm Description
Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents.
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Heart Rate as measured by heart rate monitor
Description
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.
Time Frame
During the procedure at 1 minute intervals
Title
Change in Blood Pressure as measured by blood pressure monitor
Description
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.
Time Frame
During the procedure at 1 minute intervals
Secondary Outcome Measure Information:
Title
Emergence Phenomenon as measured by yes/no questions regarding participant experience.
Description
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.
Time Frame
Immediately after the procedure and by phone the next day
Title
Satisfaction among Children by global rating scale
Description
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.
Time Frame
Immediately after the procedure
Title
Satisfaction among Guardians by global rating scale
Description
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.
Time Frame
Immediately after the procedure
Title
Satisfaction among Emergency Staff by global rating scale
Description
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.
Time Frame
Immediately after the procedure
Title
Type and dose of medication
Description
Amount of medication and what medications were used will be gathered from the nursing notes.
Time Frame
Intraoperative
Title
Time difference of the procedure
Description
Time the procedure takes to complete with or without VR will be recorded to determine if there is any difference.
Time Frame
Intraoperative
Title
Length of stay in the Emergency Department
Description
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.
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Goldman, MD
Phone
604-875-2345
Ext
7333
Email
rgoldman@cw.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ran Goldman, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran D Goldman, MD
Phone
(604) 875-2346
Ext
7333
Email
rgoldman@bc.cw.ca
12. IPD Sharing Statement
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Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
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