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

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

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.

Study Overview

• Status: Completed
• Conditions: Virtual Reality; Radiology; Paediatrics
• Intervention / Treatment: Behavioral: Virtual Reality; Behavioral: Simulator Preparation; Behavioral: Preparation Booklet for Non-Sedated MRI

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • BC Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motrak Assessment	The predictive success in avoiding sedation will be measured by a head motion tracking system, Motrak.	20 minutes
Child Anxiety	The Venham Picture Test will be used to assess procedural anxiety.	5 minutes at three time-points

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Anxiety	The Short State Trait Anxiety Inventory will be used to assess parental anxiety.	5 minutes at three time-points
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)
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
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

Collaborators and Investigators

• Sponsor: British Columbia Children's Hospital
• Collaborators: University of British Columbia
• Investigators: Principal Investigator: John Jacob, Provincial Health Services Authority

Publications and helpful links

General Publications

• Stunden C, Stratton K, Zakani S, Jacob J. Comparing a Virtual Reality-Based Simulation App (VR-MRI) With a Standard Preparatory Manual and Child Life Program for Improving Success and Reducing Anxiety During Pediatric Medical Imaging: Randomized Clinical Trial. J Med Internet Res. 2021 Sep 22;23(9):e22942. doi: 10.2196/22942.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: H19-00371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No