Virtual RealityVR-MRINCT03931382
Virtual Reality Preparation for Medical Imaging
A study testing Virtual Reality Simulator, Mock MRI Simulator and Standard Preparation Manual in people with Virtual Reality and Paediatrics, run by British Columbia Children's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Paediatrics, Radiology
- What is being tested?
- Virtual Reality Simulator, Mock MRI Simulator and Standard Preparation Manual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2019to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- mental disability
- significant visual and auditory impairment
- inability to speak or understand English
- history of seizures or epilepsy
- facial or head wounds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Virtual Reality as an Adjunct in Procedural Preparation for Magnetic Resonance Imaging (MRI)
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.
Read the 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.
- Conditions
- Virtual Reality, Paediatrics, Radiology
- Being tested
- Virtual Reality Simulator, Mock MRI Simulator, Standard Preparation Manual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality SimulatorBehavioural
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 SimulatorBehavioural
Also called Mock MRI
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.
Standard Preparation ManualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Behavioral: Standard Preparation Manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
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.
Measured: 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
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).
Measured: Participants were asked to indicate their satisfaction after the assessment, up to 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Jul 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, unblinded, controlled
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, John Jacob, British Columbia Children's Hospital
- Investigators
- John Jacob, Principal investigator, Provincial Health Services Authority British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931382
- Sponsor's protocol ID
- H19-00371
- Acronym
- VR-MRI
- Status last verified
- Aug 2024
- First submitted
- 26 Apr 2019
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34550072
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Virtual Reality as an Adjunct in Procedural Preparation for Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT03931382
- Acronym / sponsor ID
- VR-MRI / H19-00371
- Conditions
- Virtual Reality, Paediatrics, Radiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- British Columbia Children's HospitalUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized, unblinded, controlled
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: Virtual Reality SimulatorIn 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. |
| Mock MRI | Active comparator | Behavioral: Mock MRI SimulatorIn this arm, participants will receive 45 minutes of preparation using the standard of care simulator, conducted by a Child Life Specialist |
| Manual | Active comparator | Behavioral: Standard Preparation ManualIn this arm, participants will receive 45 minutes of preparation using the standard of care MRI Preparation Booklet for non-sedated MRIs. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- mental disability
- significant visual and auditory impairment
- inability to speak or understand English
- history of seizures or epilepsy
- facial or head wounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality SimulatorThe 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. | Behavioural | Virtual Reality |
| Mock MRI SimulatorAlso: Mock MRIThe 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. | Behavioural | Mock MRI |
| Standard Preparation ManualThe 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. | Behavioural | Manual |
Primary outcome
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.
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).
2 secondary outcomes
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]).
Child Satisfaction
Time frame: Participants were asked to indicate their satisfaction after the assessment, up to 15 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34550072Stunden 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Jacob principal investigator
Provincial Health Services Authority British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Simulator, Mock MRI Simulator and Standard Preparation Manual in people with Virtual Reality and Paediatrics, run by British Columbia Children's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Success (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03931382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.