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OpenTrials
Completed

NCT Number: NCT03931382

Virtual Reality Preparation for Medical Imaging

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.

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Key information

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: 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.

Primary outcomes

  1. Percentage of Participants With Success

    Time frame: 20 minutes

    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.

  2. Child Anxiety

    Time frame: 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]).

    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).

Secondary outcomes

  1. Caregiver/Parental Anxiety

    Time frame: 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]).

    Caregiver anxiety was measured with the short State-Trait Anxiety Inventory (STAI; score 6-24), a 6-item, adapted version of the well-validated Spielberger STAI Scale. The short form of the STAI includes six statements. The range for the short STAI is 6 to 24 points, with 6 points signifying no anxiety and 24 points signifying the highest level of anxiety.

  2. Child Satisfaction

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

    For measuring child satisfaction, participants were asked to indicate how satisfied they were with the preparation program by pointing to a visual analog scale ranging from 0 (terrible) to 100 (fantastic).

Other outcomes

  1. Parental Usability

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

    The caregivers of our participants were prompted to provide usability feedback on the preparation materials at the end of the study. Caregivers were asked to complete the USE (Usefulness, Satisfaction, and Ease of Use) Questionnaire administered at the end of the study activities on a tablet. The USE Questionnaire is a 7-point Likert rating scale from 1-strongly disagree to 7-strongly agree. Caregivers were asked to rate the preparation program on measures related to usefulness (5-strongly disagree to 35-strongly agree), ease of use (4-strongly disagree to 28-strongly agree), ease of learning (3-strongly disagree to 21-strongly agree), and satisfaction (5-strongly disagree to 35-strongly agree).

  2. Assessment Time

    Time frame: 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.

    The assessment time was defined as the time spent in the simulated MRI room until the participant was discharged from the simulation experience, either as successful or noncompliant.

  3. Fun

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

    Fun was measured using the Smilyometer Likert Scale, a part of the Fun Toolkit. The Smileyometer was used before and after the children interacted with a preparation program. The rationale for using it before is that it can measure their expectations and for using it afterward is that it is assumed that the child is reporting experienced fun. After allocation to a preparatory program, children were asked how good they thought the preparation would be by pointing to the Smilyometer Likert Scale to indicate their expectation of using the intervention. After using the preparation and completing the assessment (timepoint 3 [T3]), the children were again asked how good they thought the preparation actually was using the same Smileyometer Likert scale. The Smileyometer is a Likert scale from 1 (Awful) to 5 (Fantastic).

  4. Preparation Time

    Time frame: A maximum preparation time of 45 minutes was allowed.

    The preparation time started when the study staff finished describing the preparation program, and the researcher indicated that it was time to begin the active preparation. The preparation time was stopped upon indication that the participant felt ready to take the assessment. This time frame was selected as it was the allotted appointment time provided by our hospital CLP to prepare patients and their families for medical imaging procedures.

  5. Number of Participants Who Would Recommend to a Friend

    Time frame: Whether the participant would recommend the preparation to a friend was asked after participants prepared for the MRI and completed the assessment [T3], up to 15 minutes.

    We asked the children if they would recommend the preparation to a friend who needed an MRI.

Sponsors and collaborators

Lead sponsor

British Columbia Children's Hospital

Other

Collaborators

  • University of British Columbia

Registry information

Official study title

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

Acronym: VR-MRI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2019
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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