Paediatrics, Radiology, Virtual Reality
Conditions
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
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.
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
Study design
Intervention model description
randomized, unblinded, controlled
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Success | 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. |
| Child Anxiety | 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
| Measure | Time frame | Description |
|---|---|---|
| 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]). | 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 Satisfaction | 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
| Measure | Time frame | Description |
|---|---|---|
| Parental Usability | 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). |
| Number of Participants Who Would Recommend to a Friend | 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. |
| 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. | 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. |
| 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. | 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 Time | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Equipment malfunction | 2 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Mock MRI | Manual | Total | Virtual Reality |
|---|---|---|---|---|
| Age, Continuous | 9.17 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 imaging | 15 participants | 12 participants | 43 participants | 13 participants |
| History with magnetic resonance imaging | 1 participants | 3 participants | 7 participants | 3 participants |
| History with magnetic resonance imaging simulator | 1 participants | 0 participants | 3 participants | 2 participants |
| History with virtual reality | 25 participants | 18 participants | 70 participants | 24 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment Canada | 30 participants | 24 participants | 84 participants | 30 participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 33 Participants | 12 Participants |
| Sex: Female, Male Male | 20 Participants | 13 Participants | 51 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 24 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 24 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 24 |
Outcome results
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]).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Virtual Reality | Child Anxiety | Timepoint 2 | 0 score on a scale |
| Virtual Reality | Child Anxiety | Timepoint 1 | 0 score on a scale |
| Virtual Reality | Child Anxiety | Timepoint 3 | 0 score on a scale |
| Mock MRI | Child Anxiety | Timepoint 2 | 1 score on a scale |
| Mock MRI | Child Anxiety | Timepoint 1 | 0 score on a scale |
| Mock MRI | Child Anxiety | Timepoint 3 | 0 score on a scale |
| Manual | Child Anxiety | Timepoint 1 | 0 score on a scale |
| Manual | Child Anxiety | Timepoint 3 | 0 score on a scale |
| Manual | Child Anxiety | Timepoint 2 | 0 score on a scale |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality | Percentage of Participants With Success | 9 Participants |
| Mock MRI | Percentage of Participants With Success | 14 Participants |
| Manual | Percentage of Participants With Success | 12 Participants |
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]).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Virtual Reality | Caregiver/Parental Anxiety | Timepoint 2 | 6 score on a scale |
| Virtual Reality | Caregiver/Parental Anxiety | Timepoint 1 | 6.5 score on a scale |
| Virtual Reality | Caregiver/Parental Anxiety | Timepoint 3 | 6 score on a scale |
| Mock MRI | Caregiver/Parental Anxiety | Timepoint 2 | 8 score on a scale |
| Mock MRI | Caregiver/Parental Anxiety | Timepoint 1 | 7 score on a scale |
| Mock MRI | Caregiver/Parental Anxiety | Timepoint 3 | 6 score on a scale |
| Manual | Caregiver/Parental Anxiety | Timepoint 1 | 8 score on a scale |
| Manual | Caregiver/Parental Anxiety | Timepoint 3 | 8 score on a scale |
| Manual | Caregiver/Parental Anxiety | Timepoint 2 | 10 score on a scale |
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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Virtual Reality | Child Satisfaction | 80 score on a scale | Standard Deviation 27 |
| Mock MRI | Child Satisfaction | 90 score on a scale | Standard Deviation 12 |
| Manual | Child Satisfaction | 73.5 score on a scale | Standard Deviation 27 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality | Assessment Time | 11.79 Minutes | Standard Deviation 1.99 |
| Mock MRI | Assessment Time | 10.17 Minutes | Standard Deviation 3.44 |
| Manual | Assessment Time | 11.19 Minutes | Standard Deviation 3.8 |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Virtual Reality | Fun | Expected | 4 score on a scale |
| Virtual Reality | Fun | Actual | 4 score on a scale |
| Mock MRI | Fun | Expected | 4 score on a scale |
| Mock MRI | Fun | Actual | 4 score on a scale |
| Manual | Fun | Expected | 3 score on a scale |
| Manual | Fun | Actual | 4 score on a scale |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality | Number of Participants Who Would Recommend to a Friend | 28 Participants |
| Mock MRI | Number of Participants Who Would Recommend to a Friend | 22 Participants |
| Manual | Number of Participants Who Would Recommend to a Friend | 14 Participants |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Virtual Reality | Parental Usability | Easy to learn | 18 score on a scale |
| Virtual Reality | Parental Usability | Parental Satisfaction | 31 score on a scale |
| Virtual Reality | Parental Usability | Easy to use | 24 score on a scale |
| Virtual Reality | Parental Usability | Usefulness | 31 score on a scale |
| Mock MRI | Parental Usability | Usefulness | 30 score on a scale |
| Mock MRI | Parental Usability | Easy to use | 24 score on a scale |
| Mock MRI | Parental Usability | Parental Satisfaction | 31 score on a scale |
| Mock MRI | Parental Usability | Easy to learn | 18 score on a scale |
| Manual | Parental Usability | Parental Satisfaction | 27 score on a scale |
| Manual | Parental Usability | Usefulness | 28.5 score on a scale |
| Manual | Parental Usability | Easy to use | 24 score on a scale |
| Manual | Parental Usability | Easy to learn | 19.5 score on a scale |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Virtual Reality | Preparation Time | 22.05 minutes |
| Mock MRI | Preparation Time | 15.06 minutes |
| Manual | Preparation Time | 9.98 minutes |