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

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

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.

Study Overview

• Status: Unknown
• Conditions: Child, Preschool
• Intervention / Treatment: Device: Virtual Reality

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Ran Goldman, MD; Phone Number: 7333 604-875-2345; Email: rgoldman@cw.bc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • Recruiting
      • BC Children's Hospital
      • Contact: Ran D Goldman, MD; Phone Number: 7333 604-875-2345; Email: rgoldman@cw.bc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of demonstration required by child measured in seconds	Length of Time (seconds) the demonstration took until the child was ready to wear the VR headset	Recorded during Stage 1 of intervention, before child puts headset on. Up to 120 seconds.
Mood/Behaviors during Handling of VR rated 1-100 on a Visual analogue scale	Rated 1-100 on a Visual analogue scale from extremely negative to extremely positive by the research assistant.	Recorded during Stage 3 of intervention. Up to 1 minute while child handles and puts on headset.
Time using VR in minutes	Length of Time (Minutes) the child was using the VR set on their head (up to 10 minutes)	Recorded during Stage 5 of the procedure. Up to 10 minutes.
Willingness to Return VR as measured by a three point scale	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	Recorded during Stage 6 of the procedure
Patient experience questions as measured by a 4 point scale and open ended question	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.	Immediately after the intervention (within 10 minutes)
Parent experience questions as measured by a 4 point scale and open ended question	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.	Immediately after the intervention (within 10 minutes)

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): November 9, 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): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Virtual Reality
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: H18-01924

Drug and device information, study documents

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