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

NCT ID: NCT03692377

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-09
• Study Completion Date: 2019-09-21

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Virtual Reality

Intervention Type: 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)

Interventions

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)

Intervention Type: 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Ran Goldman

Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ran Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

BC Children's Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ran Goldman, MD

Role: CONTACT

rgoldman@cw.bc.ca

604-875-2345 ext. 7333

Facility Contacts

Ran D Goldman, MD

Role: primary

rgoldman@cw.bc.ca

604-875-2345 ext. 7333

Other Identifiers

H18-01924

Identifier Type: -

Identifier Source: org_study_id