How Young is Too Young for Virtual Reality? Determining Usability and Acceptability in Ages 2-6 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

Usability in Stage 4 (Applying the headset on the eyes of the child with software application) as measured by a five point scale.[ Time Frame: Recorded during Stage 4 of the procedure ]

The research assistant will assess how the child reacts to wearing VR as measured by a five point scale: - Child tries to use the headset themselves with no help - Child helps the research assistant to put the headset on their face - Child is passive while the research assistant to put the headset on their face - Child resist by pushing the research assistant's hands - Child significantly resist/ cry/ wave arms / push feet

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Time of demonstration required by child measured in seconds[ Time Frame: Recorded during Stage 1 of intervention, before child puts headset on. Up to 120 seconds. ]
Length of Time (seconds) the demonstration took until the child was ready to wear the VR headset
Mood/Behaviors during Handling of VR rated 1-100 on a Visual analogue scale[ Time Frame: Recorded during Stage 3 of intervention. Up to 1 minute while child handles and puts on headset. ]
Rated 1-100 on a Visual analogue scale from extremely negative to extremely positive by the research assistant.
Time using VR in minutes[ Time Frame: Recorded during Stage 5 of the procedure. Up to 10 minutes. ]
Length of Time (Minutes) the child was using the VR set on their head (up to 10 minutes)
Willingness to Return VR as measured by a three point scale[ Time Frame: Recorded during Stage 6 of the procedure ]
The research assistant will record willingness to return VR as measured by a three point scale: - Give away the headset after requested to do so once - Give away the headset after requested to do so several times - Want to continue playing and does not give the set away
Patient experience questions as measured by a 4 point scale and open ended question[ Time Frame: Immediately after the intervention (within 10 minutes) ]
The research assistant will ask the patient four questions on a four point scale: How easy or hard it was to wear the VR goggles [1-very hard …………. 4-very easy] How easy or hard it was to see the video [1-very hard …………. 4-very easy] Do they want their parents to also try the VR goggles [1-not at all …………. 4-yes, immediately] Would they like to play again with the VR goggles [1-not at all …………. 4-yes, immediately] One open ended question will be asked about any problems with VR.
Parent experience questions as measured by a 4 point scale and open ended question[ Time Frame: Immediately after the intervention (within 10 minutes) ]
The research assistant will ask the patient two questions on a four point scale: How easy or hard it was for your child to wear the VR goggles [1-very hard …………. 4-very easy] Do they want their child to try the VR goggles next time they need a procedure in the hospital [1-not at all …………. 4-yes, immediately] One open ended question will be asked about any problems with VR.

Descriptive Information

Brief Title ^ICMJE

How Young is Too Young for Virtual Reality? Determining Usability and Acceptability in Ages 2-6 in the Emergency Department

Official Title ^ICMJE

How Young is Too Young for Virtual Reality ? Determination of the Usability and Acceptability of Virtual Reality for Health Care Purposes Among Children 2-6 Years of Age in the Emergency Department

Brief Summary

Children who present to the emergency department often require painful procedures (intravenous catheterization, laceration repair, fracture reduction, etc.). Virtual reality (VR) has been presented as a way of managing pain and anxiety in children undergoing painful procedures but most studies are limited to children 6 or older. The present study seeks to determine the youngest age (2-6) of future subjects in research of VR and clinical care. Virtual Reality 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. Investigators will instruct and observe children age 2-6 in using a VR device and document how easy the device is to use for the child. The children will have the opportunity to select an application and play with the device for 10 minutes before being asked about their experience with the device. Parents/Guardians will also be asked about their child's experience with the device.

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Device: Virtual Reality
Stage 1 : Demonstration of the use of the VR headset by the research assistant (anticipated 1-2 min) Stage 2 : Child will choose the application they would like to see - they will be shown 3 pages of the three applications offered - see Fig 1 (anticipated 1-2 min) Stage 3 : Handling of the VR headset by the child (anticipated 1 min) Stage 4 : Applying the headset on the eyes of the child with software application (anticipated 1 min) Stage 5 : The child use the VR set and application (up to 10 minutes) Stage 6 : Removal of the headset (anticipated 1 min) Stage 7 : Questionnaire to child (interview - 2 minutes) Stage 8 : Questionnaire to parents/guardians (interview - 2 minutes)

Study Arms

: Children Aged 2-6
Children 2 to 6 years of age who are arriving with a guardian to the Emergency Department with a low acuity condition (Canadian Triage scale (CTAS) 4 or 5) and are waiting to be seen by the doctor, or are waiting for test results.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

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 2-6 years of age 2. Patients arrived with a legal guardian to the emergency department 3. Parents will sign a consent form and children will agree verbally to participate 4. Triage category 4 or 5 (lowest acuity) Exclusion Criteria: 1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, neurological or other condition limiting communication) 2. Facial features or injury prohibiting wearing the VR goggles 3. Painful procedures in the emergency before being approached (such as blood testing, IV, catheterization, immunization, laceration repair) 4. Child is suffering pain or distress at a level that prohibit focusing on the study for 20 minutes, as assessed by the research assistant

Sex/Gender

Sexes Eligible for Study:

All

Ages

2 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

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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