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Virtual Reality Preparation for Medical Imaging

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03931382
Acronym
VR-MRI
Enrollment
89
Registered
2019-04-30
Start date
2019-07-01
Completion date
2020-02-29
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatrics, Radiology, Virtual Reality

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.

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.

Interventions

BEHAVIORALMock MRI Simulator

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.

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.

BEHAVIORALStandard Preparation Manual

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.

Sponsors

University of British Columbia
CollaboratorOTHER
British Columbia Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

randomized, unblinded, controlled

Eligibility

Sex/Gender
ALL
Age
4 Years to 13 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Success20 minutesMovement 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.
Child AnxietyChildren 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

MeasureTime frameDescription
Caregiver/Parental AnxietyParents 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.
Child SatisfactionParticipants 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

MeasureTime frameDescription
Parental UsabilityCaregivers 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).
Number of Participants Who Would Recommend to a FriendWhether 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.
Assessment TimeA 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.
FunParticipants 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).
Preparation TimeA 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.

Countries

Canada

Participant flow

Recruitment details

The study was carried out between July 2019 and February 2020.

Pre-assignment details

Participants were excluded if they had mental disability, current concussion, significant visual and/or auditory impairment, inability to speak and understand English, history of seizures or epilepsy, facial or head wounds, or inability to move their head in all directions.

Participants by arm

ArmCount
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. 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.
30
Mock MRI
In this arm, participants will receive 45 minutes of preparation using the standard of care simulator, conducted by a Child Life Specialist 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.
30
Manual
In this arm, participants will receive 45 minutes of preparation using the standard of care MRI Preparation Booklet for non-sedated MRIs. Manual: 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.
24
Total84

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyEquipment malfunction202
Overall StudyWithdrawal by Subject010

Baseline characteristics

CharacteristicMock MRIManualTotalVirtual Reality
Age, Continuous9.17 years
STANDARD_DEVIATION 2.65
8.88 years
STANDARD_DEVIATION 2.79
9.12 years
STANDARD_DEVIATION 2.65
9.27 years
STANDARD_DEVIATION 2.61
History with any other medical imaging15 participants12 participants43 participants13 participants
History with magnetic resonance imaging1 participants3 participants7 participants3 participants
History with magnetic resonance imaging simulator1 participants0 participants3 participants2 participants
History with virtual reality25 participants18 participants70 participants24 participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Canada
30 participants24 participants84 participants30 participants
Sex: Female, Male
Female
10 Participants11 Participants33 Participants12 Participants
Sex: Female, Male
Male
20 Participants13 Participants51 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 300 / 24
other
Total, other adverse events
0 / 300 / 300 / 24
serious
Total, serious adverse events
0 / 300 / 300 / 24

Outcome results

Primary

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).

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]).

ArmMeasureGroupValue (MEDIAN)
Virtual RealityChild AnxietyTimepoint 20 score on a scale
Virtual RealityChild AnxietyTimepoint 10 score on a scale
Virtual RealityChild AnxietyTimepoint 30 score on a scale
Mock MRIChild AnxietyTimepoint 21 score on a scale
Mock MRIChild AnxietyTimepoint 10 score on a scale
Mock MRIChild AnxietyTimepoint 30 score on a scale
ManualChild AnxietyTimepoint 10 score on a scale
ManualChild AnxietyTimepoint 30 score on a scale
ManualChild AnxietyTimepoint 20 score on a scale
Primary

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.

Time frame: 20 minutes

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Virtual RealityPercentage of Participants With Success9 Participants
Mock MRIPercentage of Participants With Success14 Participants
ManualPercentage of Participants With Success12 Participants
Secondary

Caregiver/Parental Anxiety

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.

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]).

ArmMeasureGroupValue (MEDIAN)
Virtual RealityCaregiver/Parental AnxietyTimepoint 26 score on a scale
Virtual RealityCaregiver/Parental AnxietyTimepoint 16.5 score on a scale
Virtual RealityCaregiver/Parental AnxietyTimepoint 36 score on a scale
Mock MRICaregiver/Parental AnxietyTimepoint 28 score on a scale
Mock MRICaregiver/Parental AnxietyTimepoint 17 score on a scale
Mock MRICaregiver/Parental AnxietyTimepoint 36 score on a scale
ManualCaregiver/Parental AnxietyTimepoint 18 score on a scale
ManualCaregiver/Parental AnxietyTimepoint 38 score on a scale
ManualCaregiver/Parental AnxietyTimepoint 210 score on a scale
Secondary

Child Satisfaction

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).

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

ArmMeasureValue (MEDIAN)Dispersion
Virtual RealityChild Satisfaction80 score on a scaleStandard Deviation 27
Mock MRIChild Satisfaction90 score on a scaleStandard Deviation 12
ManualChild Satisfaction73.5 score on a scaleStandard Deviation 27
Other Pre-specified

Assessment 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.

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.

ArmMeasureValue (MEAN)Dispersion
Virtual RealityAssessment Time11.79 MinutesStandard Deviation 1.99
Mock MRIAssessment Time10.17 MinutesStandard Deviation 3.44
ManualAssessment Time11.19 MinutesStandard Deviation 3.8
Other Pre-specified

Fun

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).

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.

ArmMeasureGroupValue (MEDIAN)
Virtual RealityFunExpected4 score on a scale
Virtual RealityFunActual4 score on a scale
Mock MRIFunExpected4 score on a scale
Mock MRIFunActual4 score on a scale
ManualFunExpected3 score on a scale
ManualFunActual4 score on a scale
Other Pre-specified

Number of Participants Who Would Recommend to a Friend

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

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Virtual RealityNumber of Participants Who Would Recommend to a Friend28 Participants
Mock MRINumber of Participants Who Would Recommend to a Friend22 Participants
ManualNumber of Participants Who Would Recommend to a Friend14 Participants
Other Pre-specified

Parental Usability

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).

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

Population: 1 participant in the virtual reality arm declined to do the survey; 5 participants in the mock MRI arm declined to do the survey; 4 participants in the booklet arm declined to do the survey.

ArmMeasureGroupValue (MEDIAN)
Virtual RealityParental UsabilityEasy to learn18 score on a scale
Virtual RealityParental UsabilityParental Satisfaction31 score on a scale
Virtual RealityParental UsabilityEasy to use24 score on a scale
Virtual RealityParental UsabilityUsefulness31 score on a scale
Mock MRIParental UsabilityUsefulness30 score on a scale
Mock MRIParental UsabilityEasy to use24 score on a scale
Mock MRIParental UsabilityParental Satisfaction31 score on a scale
Mock MRIParental UsabilityEasy to learn18 score on a scale
ManualParental UsabilityParental Satisfaction27 score on a scale
ManualParental UsabilityUsefulness28.5 score on a scale
ManualParental UsabilityEasy to use24 score on a scale
ManualParental UsabilityEasy to learn19.5 score on a scale
Other Pre-specified

Preparation Time

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.

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

ArmMeasureValue (MEAN)
Virtual RealityPreparation Time22.05 minutes
Mock MRIPreparation Time15.06 minutes
ManualPreparation Time9.98 minutes

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026