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

NCT03692377 | Unknown

• 1 other identifier: H18-01924
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Child, Preschool

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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: 1. \- Child tries to use the headset themselves with no help 2. \- Child helps the research assistant to put the headset on their face 3. \- Child is passive while the research assistant to put the headset on their face 4. \- Child resist by pushing the research assistant's hands 5. \- Child significantly resist/ cry/ wave arms / push feet

  Recorded during Stage 4 of the procedure

Secondary Outcomes (6)

• Time of demonstration required by child measured in seconds

  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

  Recorded during Stage 3 of intervention. Up to 1 minute while child handles and puts on headset.

• Time using VR in minutes

  Recorded during Stage 5 of the procedure. Up to 10 minutes.

• Willingness to Return VR as measured by a three point scale

  Recorded during Stage 6 of the procedure

• Patient experience questions as measured by a 4 point scale and open ended question

  Immediately after the intervention (within 10 minutes)

Study Arms (1)

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

Interventions

Virtual Reality DEVICE

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)

Children Aged 2-6

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Children age 2-6 years of age
• Patients arrived with a legal guardian to the emergency department
• Parents will sign a consent form and children will agree verbally to participate
• Triage category 4 or 5 (lowest acuity)

You may not qualify if:

• Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, neurological or other condition limiting communication)
• Facial features or injury prohibiting wearing the VR goggles
• Painful procedures in the emergency before being approached (such as blood testing, IV, catheterization, immunization, laceration repair)
• Child is suffering pain or distress at a level that prohibit focusing on the study for 20 minutes, as assessed by the research assistant

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

Study Officials

• Ran Goldman, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ran Goldman, MD

CONTACT

604-875-2345; rgoldman@cw.bc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 2, 2018
• Study Start: November 9, 2018
• Primary Completion: September 21, 2019
• Study Completion: September 21, 2019
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

CA (1)