Virtual Reality Clinical Trial
— VR MRIOfficial title:
Evaluating Virtual Reality as an Adjunct in Procedural Preparation for Magnetic Resonance Imaging (MRI)
Verified date | March 2020 |
Source | British Columbia Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot project aims to establish evidence to investigate whether a virtual reality intervention can be implemented to reduce anxiety and efficiently prepare children for non-sedated MRI assessments. The study consists of comparing the current modes of delivery though a mock behavioural assessment and inquiry into the acceptability and utility of the intervention components, including potential barriers to adherence or behavioural change that could have unintended consequences.
Status | Completed |
Enrollment | 89 |
Est. completion date | February 29, 2020 |
Est. primary completion date | February 29, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 13 Years |
Eligibility |
Inclusion Criteria: - open recruitment of participants between the ages of 4-to-18 years Please note that this trial does not include a diagnostic MRI. Participants do not need to be scheduled for a diagnostic MRI for inclusion. Exclusion Criteria: - mental disability - significant visual and auditory impairment - inability to speak or understand English - history of seizures or epilepsy - facial or head wounds |
Country | Name | City | State |
---|---|---|---|
Canada | BC Children's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
British Columbia Children's Hospital | University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Motrak Assessment | The predictive success in avoiding sedation will be measured by a head motion tracking system, Motrak. | 20 minutes | |
Primary | Child Anxiety | The Venham Picture Test will be used to assess procedural anxiety. | 5 minutes at three time-points | |
Secondary | Parental Anxiety | The Short State Trait Anxiety Inventory will be used to assess parental anxiety. | 5 minutes at three time-points | |
Secondary | Length of Stay | Length of stay is defined as the duration, in minutes, from starting the preparation segment to completion of the simulated assessment. Inter-segment times will also be reported. Preparation time is capped at 45 minutes. Assessment time is capped at 20 minutes. | 2 hours (max) | |
Secondary | Child Perceived Usability | The Smileyometer will be used to measure the opinions of the preparation programs in children. This will be supplemented with several open-ended questions on the preparation materials according to criteria of fun, ease of use, and how good it was for learning about the MRI experience. | 10 minutes | |
Secondary | Parental Usability | The Usefulness, Satisfaction, Ease of Use (USE) questionnaire will be used to compare the VR application to the simulated MRI experience and will include assessments of usefulness, ease-of-use, ease-of-learning, and satisfaction. | 10 minutes |
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