Virtual Reality Distraction for Anxiety (VR-IMAGINE)

NCT04988516 | Unknown

• 1 other identifier: IMAGINE (HMR)
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Magnetic Resonance Imaging; Pediatric; Virtual Reality; Anxiety

Keywords

MRI; Magnetic Resonance Imaging; Pediatric; Virtual Reality; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (12)

• Sense of presence/engagement

  Measured after intervention - 15 minutes (T1)

• Head deviation in space

  Measured for the duration of the VR simulation for an approximate duration of 15 minutes (From T0 to T1)

• Heart Rate

  Measured at baseline (T0), immediately after the VR intervention at 15 minutes (T1), and measured after the MRI at 45 minutes (T2)

• Oxygen saturation

  Measured at baseline (T0), immediately after the VR intervention at 15 minutes (T1), and measured after the MRI at 45 minutes (T2)

• Parent's satisfaction

  Measured at 45 minutes (T2)

Study Arms (2)

Virtual Reality Distraction

EXPERIMENTAL

Use of Virtual Reality (VR) before the MRI.

Device: Virtual reality

Standard Treatment

ACTIVE COMPARATOR

Standard Treatment used at the radiology department.

Other: Standard protocol

Interventions

Virtual reality DEVICE

The pre-procedural IVR game preparation (IMAGINE) was developed by Paperplane Therapeutics® (intervention development team). IMAGINE is an immersive virtual reality simulation aiming to reduce the anxiety and phobic reactions of young patients and to better prepare them for this exam. Since the game is a preparation, it is a no success game and is independent of the ability and previous experience of the child with video games. It offers an immersive and fun simulation that aims to desensitize young patients to MRI and transform an anxiety-inducing experience into a fun play session. The participant will learn about the main principles of magnetic resonance imaging and experience a very realistic simulation of the MRI exam. This will allow children to prepare for the MRI scanner by enabling them to experience the process of undergoing an MRI exam beforehand.

Virtual Reality Distraction

Standard protocol OTHER

The usual care group will only receive the standard preparation, which comprises of an explanation of the MRI procedure given by the radiology technician as per the radiology department's protocol. The research nurse will be able to complete any information should they find it incomplete or substandard.

Standard Treatment

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Maisonneuve-Rosemont Hospital: collaborator

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Related Publications (1)

• Le May S, Genest C, Hung N, Francoeur M, Guingo E, Paquette J, Fortin O, Guay S. The Efficacy of Virtual Reality Game Preparation for Children Scheduled for Magnetic Resonance Imaging Procedures (IMAGINE): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 13;11(6):e30616. doi: 10.2196/30616.

  PMID: 35700000 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

AIEOP acute lymphoblastic leukemia protocol

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sylvie Le May, PhD

  Research Centre CHU Sainte-Justine

  PRINCIPAL INVESTIGATOR

• Christine Genest, PhD

  Research Centre IUSMM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie Le May, PhD

CONTACT

514-345-4931; sylvie.lemay@umontreal.ca

Christine Genest, PhD

CONTACT

514 343-6111; christine.genest@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: August 3, 2021
• Study Start: May 27, 2022
• Primary Completion: August 30, 2024
• Study Completion: May 30, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)