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Virtual Reality Preparation for Medical Imaging (VR-MRI)

B

British Columbia Children's Hospital

Status

Completed

Conditions

Paediatrics
Radiology
Virtual Reality

Treatments

Behavioral: Mock MRI Simulator
Behavioral: Standard Preparation Manual
Behavioral: Virtual Reality Simulator

Study type

Interventional

Funder types

Other

Identifiers

NCT03931382
H19-00371

Details and patient eligibility

About

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.

Full 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.

Enrollment

89 patients

Sex

All

Ages

4 to 13 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

89 participants in 3 patient groups

Virtual Reality
Experimental group
Description:
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.
Treatment:
Behavioral: Virtual Reality Simulator
Mock MRI
Active Comparator group
Description:
In this arm, participants will receive 45 minutes of preparation using the standard of care simulator, conducted by a Child Life Specialist
Treatment:
Behavioral: Mock MRI Simulator
Manual
Active Comparator group
Description:
In this arm, participants will receive 45 minutes of preparation using the standard of care MRI Preparation Booklet for non-sedated MRIs.
Treatment:
Behavioral: Standard Preparation Manual

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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