Anxiety Clinical Trial
Official title:
Virtual Reality Distraction for Anxiety in Children During MRIs : A Randomized Controlled Trial
Background: Magnetic resonance imaging (MRI) has been known for almost forty years to generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI to be repeated with sedation. Very few studies seemed to have looked at the effect of virtual reality (VR) on anxiety in children scheduled for an MRI and how to identify which children are more responsive. Objective: The aims of this study are three-fold: 1- to develop an algorithm of predictability based on biofeedback; 2- to address feasibility and acceptability of a pre-procedural immersive VR (IVR) game preparation for anxiety management during MRIs and 3- to examine the efficacy of IVR game preparation compared to usual care for the management of procedural anxiety during MRIs. Methods: This study will first consist of a field test phase with 10 participants, aged 7 to 17 years old, to develop a predictive algorithm for biofeedback solution and to address the feasibility and acceptability of the research. Following the field test, a RCT will be completed using a parallel design with two groups: 1) experimental group (pre-procedural IVR game preparation), 2) usual care group (standard care as per radiology department's protocol) in an equal ratio of 49 participants per group for a total of 98 participants. Recruitment will be done at CIUSSS de l'Est de l'Île de Montréal, Quebec, Canada. The experimental group will receive a pre-procedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI. Participants will complete a questionnaire to assess the acceptability, feasibility and incidence of side effects related to the intervention and the biofeedback device. Data collected will include socio-demographic, clinical characteristics and measures of procedure related-anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (STAIC-F) and the Child Fear Scale (CFS, 0-4). Physiological signs will be noted and include heart rate, skin conductance, hand temperature and muscle tension. Measures of healthcare professionals, parents, and participants' level of satisfaction will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a significance level (α) of 0.05. Conclusions: Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI. The biofeedback will help predict which children are more responsive to this type of intervention. This study will guide future medical practice by providing evidence-based knowledge on a non-pharmacological therapeutic modality for anxiety management in children scheduled for an MRI.
Status | Recruiting |
Enrollment | 98 |
Est. completion date | May 30, 2025 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility | Inclusion Criteria: - aged from 7 to 17 years old - required to undergo MRI - accompanied by a consenting parent or legal guardian who can understand, read and write either French or English Exclusion Criteria: - have a diagnosis of epilepsy or any other condition preventing them from playing a virtual reality game - cannot stand a sitting or semi-upright sitting position (Fowler's position) during the preparation as the VR gear requires an angle of at least 30 degrees for head-tracking |
Country | Name | City | State |
---|---|---|---|
Canada | Maisonneuve-Rosemont Hospital | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital | Maisonneuve-Rosemont Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of state-trait anxiety in children | Anxiety level will be measured using the State-Trait Anxiety Inventory for Children (French-Canadian Version) (STAIC-F), a 40-item questionnaire separated equaly into two parts (State & Trait) tailored for assessing anxiety in children. Each of the questions (items) use a 0-4 scale where 0 is ''Almost never'' (Presque jamais) and 4 is ''Almost all the time'' (Presque toujours). The First part (first 20 questions) of the questionnaire measures the State (situational) anxiety of a specific situation and will be measured at T0, T1 and T2. The Second part (last 20 questions) measure the trait anxiety of the person and will only be measured at T0. | Change from Baseline (T0) at 15 minutes (T1) and at 30 minutes (T2) | |
Primary | Level of anxiety | Will also be assessed using the Child Fear Scale (CFS). 0 (no fear/anxiety) through 4 (extremely fearful/anxious). | Change from Baseline (T0) at 15 minutes (T1) and at 45 minutes (T2) | |
Secondary | Sense of presence/engagement | Will be assessed using the Graphic Rating Scale (GRS), a 7-item Likert-type scale tailored for virtual reality intervention level of immersiveness. Each of the 7 questions (items) use a 0-10 scale where 0 is Not at all and 10 is a lot/extreme. The meaning of the scale is always the same, but the words may change to fit the question. | Measured after intervention - 15 minutes (T1) | |
Secondary | Head deviation in space | The head deviation during the simulation is measured continuously for the entire duration of the intervention through the positioning cameras, accelerometer and gyroscopes in the headset. | Measured for the duration of the VR simulation for an approximate duration of 15 minutes (From T0 to T1) | |
Secondary | Heart Rate | Measurement of Heart rate via a pulse oximeter will be measured using the biofeedback device that will continuously capture and record physiological signs. | Measured at baseline (T0), immediately after the VR intervention at 15 minutes (T1), and measured after the MRI at 45 minutes (T2) | |
Secondary | Oxygen saturation | Measurement of Oxygen saturation via a pulse oximeter will be measured using the biofeedback device that will continuously capture and record physiological signs. | Measured at baseline (T0), immediately after the VR intervention at 15 minutes (T1), and measured after the MRI at 45 minutes (T2) | |
Secondary | Parent's satisfaction | Will be assessed using a 0 to 10 numerical rating scale (NRS), where 0 is Not satisfied and 10 very much satisfied | Measured at 45 minutes (T2) | |
Secondary | Children's satisfaction | will be assessed using a 0 to 10 numerical rating scale where 0 indicates Not satisfied and 10 Very much satisfied | Measured at 45 minutes (T2) | |
Secondary | Healthcare professional's satisfaction | assessed using a numerical rating scale where 0 is Not Satisfied and 10 is Very much satisfied | Measured at 45 minutes (T2) | |
Secondary | Occurrence of side effects | Will be assessed and documented from enrolment until discharge | Change from Baseline (T0) to 45 minutes (T2) | |
Secondary | Procedural time | Time for completion of the MRI procedure | Measured at 45 minutes (T2) | |
Secondary | Number of rescheduled MRI | Dichotomized variable : yes or no. We will measure the percentage of participants who will require to repeat their MRI. | Measured at 45 minutes (T2) | |
Secondary | Level of State-trait anxiety in parents | Anxiety level will be measured using the State-Trait Anxiety Inventory (French-Canadian Version) (STAI-F), a 40-item questionnaire separated equaly into two parts (State & Trait) tailored for assessing anxiety. Each of the questions (items) use a 0-4 scale where 0 is ''Almost never'' (Presque jamais) and 4 is ''Almost all the time'' (Presque toujours). The First part (first 20 questions) of the questionnaire measures the State (situational) anxiety of a specific situation and will be measured at T0 and T2. The Second part (last 20 questions) measure the trait anxiety of the person and will only be measured at T0. | Measured at Baseline (T0) and Measured at 45 minutes (T2) | |
Secondary | Physiological measurement of anxiety (Alpha-Amylase) | Measurement of anxiety will be done via salivary alpha-amylase which will be collected from children and the accompanying parent. | Measured at Baseline (T0) and Measured at 45 minutes (T2) |
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