Recruiting

Virtual Reality

Sponsor:

University of British Columbia

Code:

NCT03692377

Conditions

Child, Preschool

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Study Details

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 ID

NCT03692377

Start date

Nov 9, 2018

Status verified date

Jan, 2019

Completion date

Sep 21, 2019

Anticipated

Primary completion date

Sep 21, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ran Goldman, MD

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

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Ran D Goldman, MD

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

More Information

Sponsor

University of British Columbia

Last update posted

Jan 18, 2019

Last verified

Jan, 2019

Keywords

  • Virtual Reality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2019-01-18.