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

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ClinicalTrials.gov Identifier: NCT03692377
Recruitment Status : Unknown
Verified January 2019 by Ran Goldman, University of British Columbia.
Recruitment status was:  Recruiting
First Posted : October 2, 2018
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ran Goldman, University of British Columbia

Study Description
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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.


Condition or disease Intervention/treatment
Child, Preschool Device: Virtual Reality

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : September 21, 2019
Estimated Study Completion Date : September 21, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

    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


Secondary Outcome Measures :
  1. Time of demonstration required by child measured in seconds [ Time Frame: Recorded during Stage 1 of intervention, before child puts headset on. Up to 120 seconds. ]
    Length of Time (seconds) the demonstration took until the child was ready to wear the VR headset

  2. Mood/Behaviors during Handling of VR rated 1-100 on a Visual analogue scale [ Time Frame: Recorded during Stage 3 of intervention. Up to 1 minute while child handles and puts on headset. ]
    Rated 1-100 on a Visual analogue scale from extremely negative to extremely positive by the research assistant.

  3. Time using VR in minutes [ Time Frame: Recorded during Stage 5 of the procedure. Up to 10 minutes. ]
    Length of Time (Minutes) the child was using the VR set on their head (up to 10 minutes)

  4. Willingness to Return VR as measured by a three point scale [ Time Frame: Recorded during Stage 6 of the procedure ]

    The research assistant will record willingness to return VR as measured by a three point scale:

    1. - Give away the headset after requested to do so once
    2. - Give away the headset after requested to do so several times
    3. - Want to continue playing and does not give the set away

  5. Patient experience questions as measured by a 4 point scale and open ended question [ Time Frame: Immediately after the intervention (within 10 minutes) ]

    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.


  6. Parent experience questions as measured by a 4 point scale and open ended question [ Time Frame: Immediately after the intervention (within 10 minutes) ]

    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.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692377


Contacts
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Contact: Ran Goldman, MD 604-875-2345 ext 7333 rgoldman@cw.bc.ca

Locations
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Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: Ran D Goldman, MD    604-875-2345 ext 7333    rgoldman@cw.bc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Ran Goldman, MD University of British Columbia
More Information
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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, University of British Columbia
ClinicalTrials.gov Identifier: NCT03692377    
Other Study ID Numbers: H18-01924
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ran Goldman, University of British Columbia:
Virtual Reality
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes