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Evaluating Virtual Reality as an Adjunct in Procedural Preparation for Magnetic Resonance Imaging (VR MRI)

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ClinicalTrials.gov Identifier: NCT03931382
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
John Jacob, British Columbia Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Virtual Reality Paediatrics Radiology Behavioral: Virtual Reality Behavioral: Simulator Preparation Behavioral: Preparation Booklet for Non-Sedated MRI Not Applicable

Detailed Description:

Approximately 50% of pediatric patients experience elevated anxiety and distress prior to new medical procedures. This issue is critically important because it not only impacts patient experience and is associated with psychological and physiological distress, but it can affect the efficiency of medical procedures, length of hospital stay, and resource utilization - all of which have economic impacts to both families and the health system. During medical procedures specifically, anxiety can cause non-compliance or unintentional movements which often leads to failure to complete the procedure or poor image quality, necessitating multiple attempts or the use of sedation to achieve the desired quality of imaging for diagnosis.

The impact of sedating a patient has several downstream effects, including the increased potential for adverse events, as well as the need for specialized clinical staff (i.e. Anesthesiologists, Post-Anesthetic Care Nurses, etc), medications, and lengthier post-procedural monitoring. Studies have also indicated an increase in negative post-procedural clinical outcomes, such as increase pain perception, increased pharmaceutical consumption, reductions in sleep and eating, anxiety, and greater overall patient dissatisfaction.

Child Life Specialists (CLS) are specialty trained individuals that work with patients and families to improve patient experiences during stress provoking medical procedures, such as medical imaging. Procedural preparation with a CLS for MRI involves exposure to an MRI simulator. The MRI simulator appears and sounds identical to the real MRI, but lacks a magnet and thus functionality to take real images. It's suggested that this type of non-sedated preparation program can reduce anxiety and distress, ultimately reducing sedation rates.

While access to preparation programs with the CLS have improved, capacity limitations exist and there are socioeconomic costs of only having this support available on-site at BC Children's Hospital. Transportation barriers have been repeatedly identified in the literature and by parents as a source of unmet health needs for children in both rural and inner-city populations. This is significant because it a caregiver cannot get their child to the MRI simulator, they miss the opportunity for a non-sedated MRI. Consequently, resources and the risk for complications increase. As such, a virtual reality program has the capacity to increase access to patients who live afar, who are not mobile, and who need extra practice without the financial and physical limitations associated with the traditional hospital simulation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, unblinded, controlled
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating Virtual Reality as an Adjunct in Procedural Preparation for Magnetic Resonance Imaging (MRI)
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety MRI Scans

Arm Intervention/treatment
Experimental: Virtual Reality
In this arm, participants will receive 45 minutes of preparation using a simulated virtual reality experience designed in collaboration with Medical Imaging and Child Life Specialists.
Behavioral: Virtual Reality
The VR intervention is underpinned by experiential learning and social cognitive theory, such that user will observe successful performance and simulation to encourage imitation and reinforce success in the assessment. All participants will be undergoing a simulation assessment with the head coil.

Active Comparator: Mock MRI
In this arm, participants will receive 45 minutes of preparation using the standard of care simulator, conducted by a Child Life Specialist
Behavioral: Simulator Preparation
The mock MRI is provided by the Child Life Specialist, according to the current care plan which consists of exposing children to the MRI simulator, medical devices, and procedures. The mock MRI is located within the medical imaging facility. All participants will be undergoing a simulation assessment with the head coil.
Other Name: Mock MRI

Active Comparator: Booklet
In this arm, participants will receive 45 minutes of preparation using the standard of care MRI Preparation Booklet for non-sedated MRIs.
Behavioral: Preparation Booklet for Non-Sedated MRI
The standard MRI preparation booklet provides access to a series of printed photos and text showing the MRI experience step-by-step to help prepare for MRI. All participants will be undergoing a simulation assessment with the head coil.




Primary Outcome Measures :
  1. Motrak Assessment [ Time Frame: 20 minutes ]
    The predictive success in avoiding sedation will be measured by a head motion tracking system, Motrak.

  2. Child Anxiety [ Time Frame: 5 minutes at three time-points ]
    The Venham Picture Test will be used to assess procedural anxiety.


Secondary Outcome Measures :
  1. Parental Anxiety [ Time Frame: 5 minutes at three time-points ]
    The Short State Trait Anxiety Inventory will be used to assess parental anxiety.

  2. Length of Stay [ Time Frame: 2 hours (max) ]
    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.

  3. Child Perceived Usability [ Time Frame: 10 minutes ]
    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.

  4. Parental Usability [ Time Frame: 10 minutes ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03931382


Contacts
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Contact: John Jacob 604-875-2393 john.jacob@cw.bc.ca
Contact: Chelsea Stunden 604-875-2345 ext 6512 chelsea.stunden@ubc.ca

Locations
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Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: Chelsea Stunden, MPH    6048752345 ext 6512    chelseastunden@gmail.com   
Principal Investigator: John Jacob         
Sponsors and Collaborators
British Columbia Children's Hospital
University of British Columbia
Investigators
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Principal Investigator: John Jacob Provincial Health Services Authority

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Responsible Party: John Jacob, Senior Director, Strategy and Innovation, British Columbia Children's Hospital
ClinicalTrials.gov Identifier: NCT03931382     History of Changes
Other Study ID Numbers: H19-00371
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No