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

Child, Preschool Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03692377
• Other study ID #: H18-01924
• Status: Recruiting
• Start date: November 9, 2018
• Est. completion date: September 21, 2019

Study information

• Verified date: January 2019
• Source: University of British Columbia
• Contact: Ran Goldman, MD
• Phone: 604-875-2345
• Email: rgoldman[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 21, 2019
• Est. primary completion date: September 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Child, Preschool
• Emergencies

Intervention

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)

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	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	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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)
Secondary	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)