Clinical trial NCT03692377: How Young is Too Young for Virtual Reality? Determining Usability and Acceptability in Ages 2-6 in the Emergency Department
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child, Preschool
Keywords: Virtual Reality
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Usability in Stage 4 (Applying the headset on the eyes of the child with software application) as measured by a five point scale.
timeFrame: Recorded during Stage 4 of the procedure
Secondary outcomes:
measure: Time of demonstration required by child measured in seconds
timeFrame: Recorded during Stage 1 of intervention, before child puts headset on. Up to 120 seconds.
measure: Mood/Behaviors during Handling of VR rated 1-100 on a Visual analogue scale
timeFrame: Recorded during Stage 3 of intervention. Up to 1 minute while child handles and puts on headset.
measure: Time using VR in minutes
timeFrame: Recorded during Stage 5 of the procedure. Up to 10 minutes.
measure: Willingness to Return VR as measured by a three point scale
timeFrame: Recorded during Stage 6 of the procedure
measure: Patient experience questions as measured by a 4 point scale and open ended question
timeFrame: Immediately after the intervention (within 10 minutes)
measure: Parent experience questions as measured by a 4 point scale and open ended question
timeFrame: Immediately after the intervention (within 10 minutes)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ran Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References: