Child, PreschoolNCT03692377
How Young is Too Young for Virtual Reality? Determining Usability and Acceptability in Ages 2-6 in the Emergency Department
An observational study of Child, Preschool, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Child, Preschool
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 9 Nov 2018to 21 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
Ran D Goldman, MD, 604-875-2345 ext. 7333, rgoldman@cw.bc.ca
About this study
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
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
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- - Child tries to use the headset themselves with no help
- - Child helps the research assistant to put the headset on their face
- - Child is passive while the research assistant to put the headset on their face
- - Child resist by pushing the research assistant's hands
- - Child significantly resist/ cry/ wave arms / push feet
Measured: Recorded during Stage 4 of the procedure
Secondary outcomes (6)
Time of demonstration required by child measured in seconds
Length of Time (seconds) the demonstration took until the child was ready to wear the VR headset
Measured: 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
Rated 1-100 on a Visual analogue scale from extremely negative to extremely positive by the research assistant.
Measured: Recorded during Stage 3 of intervention. Up to 1 minute while child handles and puts on headset.
Time using VR in minutes
Length of Time (Minutes) the child was using the VR set on their head (up to 10 minutes)
Measured: Recorded during Stage 5 of the procedure. Up to 10 minutes.
Willingness to Return VR as measured by a three point scale
The research assistant will record willingness to return VR as measured by a three point scale:
- - Give away the headset after requested to do so once
- - Give away the headset after requested to do so several times
- - Want to continue playing and does not give the set away
Measured: Recorded during Stage 6 of the procedure
Patient experience questions as measured by a 4 point scale and open ended question
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.
Measured: Immediately after the intervention (within 10 minutes)
Parent experience questions as measured by a 4 point scale and open ended question
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.
Measured: Immediately after the intervention (within 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start9 Nov 2018
- Primary completion21 Sep 2019 (estimated)
- Study completion21 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, PreschoolStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ran Goldman, University of British Columbia
- Investigators
- Ran Goldman, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692377
- Sponsor's protocol ID
- H18-01924
- Status last verified
- Jan 2019
- First submitted
- 20 Sep 2018
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03692377
- Acronym / sponsor ID
- H18-01924
- Conditions
- Child, Preschool
- Keywords
- Virtual Reality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 21 Sep 2019 (estimated)
- Study completion
- 21 Sep 2019 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children Aged 2-6 | – | Device: Virtual RealityChildren 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityStage 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) | Device | Children Aged 2-6 |
Primary outcome
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
6 secondary outcomes
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.
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.
Time using VR in minutes
Time frame: Recorded during Stage 5 of the procedure. Up to 10 minutes.
Willingness to Return VR as measured by a three point scale
Time frame: Recorded during Stage 6 of the procedure
Patient experience questions as measured by a 4 point scale and open ended question
Time frame: Immediately after the intervention (within 10 minutes)
Parent experience questions as measured by a 4 point scale and open ended question
Time frame: Immediately after the intervention (within 10 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ran Goldman, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child, Preschool, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ran Goldman, MD (604-875-2345 ext. 7333, rgoldman@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.