Virtual Reality Preparation for Medical Imaging

Not Applicable

Completed

Conditions: Virtual Reality
Paediatrics
Radiology

Interventions: Behavioral: Virtual Reality
Behavioral: Preparation Booklet for Non-Sedated MRI
Behavioral: Simulator Preparation

Registration Number: NCT03931382

Lead Sponsor: British Columbia Children's Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 89

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality	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.
Booklet	Preparation Booklet for Non-Sedated MRI	In this arm, participants will receive 45 minutes of preparation using the standard of care MRI Preparation Booklet for non-sedated MRIs.
Mock MRI	Simulator Preparation	In this arm, participants will receive 45 minutes of preparation using the standard of care simulator, conducted by a Child Life Specialist

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).