Virtual Reality Preparation for Medical Imaging

NCT03931382 | Completed Results

• 1 other identifier: H19-00371
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Paediatrics; Radiology

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Success

  Movement in the MRI simulation was captured by fitting participants with a motion sensor headband (MoTrak System 1.0, Psychology Software Tools Inc). Head movement was collected at 8 samples per second, yielding approximately 3300 data points per axis per participant. The threshold for a successful MRI, as defined by the department of radiology, is approximately 3-4 mm. Consequently, if at any point during the scan the participant moved \>4 mm of cumulative displacement, it was noted as a fail. Success was indicated if participants were able to complete a 6-minute head scan without surpassing 4 mm of movement at any of the 3300 data points collected. The number and percentage of participants who were successful are reported.

  20 minutes

• Child Anxiety

  Child anxiety was measured with the Venham picture test (VPT; score 0-8). The level of the patient's anxiety was classified as anxiety-free (score 0), low anxiety (scores 1-3), middle anxiety (scores 4-6), and high anxiety (scores 7-8).

  Children completed the assessment at three-time points (before preparing [T1], after preparing and upon entering the simulation room for their 6-minute scan [T2], and after the assessment [T3]).

Secondary Outcomes (2)

• Caregiver/Parental Anxiety

  Parents or caregivers were asked to complete the assessment on a tablet at the same time as children (before preparing [T1], after preparing and upon entering the simulation room for their child's 6-minute scan [T2], and after the assessment [T3]).

• Child Satisfaction

  Participants were asked to indicate their satisfaction after the assessment, up to 15 minutes.

Other Outcomes (5)

• Parental Usability

  Caregivers were asked to complete a questionnaire at the end of the study, after the assessment, up to 15 minutes.

• Assessment Time

  A maximum assessment time of 20 minutes was allowed. The time spent transitioning between activities or breaks required for reasons unrelated to the study was not accounted as time.

• Fun

  Participants were asked to rate expected fun at baseline and then rate the actual fun after completing the assessment [T3], up to 15 minutes.

Study Arms (3)

Virtual Reality

EXPERIMENTAL

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 Simulator

Mock MRI

ACTIVE COMPARATOR

In this arm, participants will receive 45 minutes of preparation using the standard of care simulator, conducted by a Child Life Specialist

Behavioral: Mock MRI Simulator

Manual

ACTIVE COMPARATOR

In this arm, participants will receive 45 minutes of preparation using the standard of care MRI Preparation Booklet for non-sedated MRIs.

Behavioral: Standard Preparation Manual

Interventions

Virtual Reality Simulator BEHAVIORAL

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.

Virtual Reality

Mock MRI Simulator BEHAVIORAL

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.

Also known as: Mock MRI

Mock MRI

Standard Preparation Manual BEHAVIORAL

The standard MRI preparation manual 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.

Manual

Eligibility Criteria

• Age: 4 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• open recruitment of participants between the ages of 4-to-18 years

You may not qualify if:

• mental disability
• significant visual and auditory impairment
• inability to speak or understand English
• history of seizures or epilepsy
• facial or head wounds

Sponsors & Collaborators

• British Columbia Children's Hospital: lead
• University of British Columbia: collaborator

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (1)

• 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.

  PMID: 34550072 RESULT

Results Point of Contact

• Title: John Jacob
• Organization: Senior Director

john.jacob@cw.bc.ca

604-875-2393

Study Officials

• John Jacob

  Provincial Health Services Authority British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director & Head, Digital Lab

Model Details: randomized, unblinded, controlled

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: April 30, 2019
• Study Start: July 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: October 28, 2024
• Results First Posted: October 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)