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临床试验/NCT05909878
NCT05909878招募中不适用

Virtual Reality Distraction for Anxiety in Children During MRIs (VR-IMAGINE at HSJ) : A Randomized Controlled Trial

St. Justine's Hospital2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2022年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
98
试验地点
2
主要终点
Level of state-trait anxiety

研究概览

简要总结

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 immersive virtual reality (IVR) on anxiety in children scheduled for an MRI.

Objectives:

The aims of this study are two-fold: 1- to address feasibility and acceptability of a pre-procedural immersive VR (IVR) game preparation for anxiety management during MRIs and 2- 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 address the feasibility and acceptability of the use of virtual reality. 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 CHU Sainte-Justine's, 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, measures of 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 biomarkers of anxiety such as alpha-amylase and other markers such as heart rate and head deviation will also be measured. 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.

Discussion:

Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI. It 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.

详细描述

BACKGROUND

Magnetic resonance imaging (MRI) is a technique that is considered non-invasive and safe as it does not use any radiation or X-rays unlike PET (positron emission tomography) scans or CT scans. MRI technology, instead, uses a magnetic field to generate images of the tissues and organs. For MRI to work as intended, the patient must remain still while laying down within a confined space for a certain amount of time. The MRI environment may be a source of anxiety for some patients. This can be due to the claustrophobic nature of the narrow space tunnel. MRIs have been in known for almost forty years to generate fear and anxiety caused by claustrophobia. In addition, MRI scanners generate loud clicking sounds while running. These loud acoustic noises may be as loud as 100dB, the equivalent of a snowmobile next to the patient. Not surprisingly, up to 30% of patients undergoing MRIs had anxiety-related reactions of various degrees of intensity. Interviews performed with small children and their parents revealed that MRIs caused anxiety in children because of their size, design and sounds. Hence, this environment is difficult to tolerate, especially for children. Oftentimes, anxious children may become restless during the exam leading to uncontrolled movements resulting in unusable images. As a consequence, this may result in a premature termination of the procedure itself, requiring the exam to be repeated ulteriorly, thus, causing subsequent episodes of anxiety.

As a result, it is becoming common practice in many hospitals' radiology department to require conscious sedation as the frequency of repeated MRI test are higher within the pediatric population. However, sedation is not without any risks or consequences. Emerging evidence suggests that sedation in children might have long-term neurocognitive side effects, in addition to the short-term procedure-related risks.

For this reason, many efforts have been put into the development of non-pharmacological methods to reduce fear and anxiety in children requiring MRI scans. Many interventions ranging from music and artwork to videogames have been used and deemed useful to relieve anxiety in children during an MRI exam. Interventions done prior to the scan have also been investigated. Among these, preprocedural patient education has been shown to decrease anxiety and enhance comprehension of MRI exams, which in turn, can serve to increase patient collaboration. However, different educational material can have different effects on reducing anxiety levels. Mock MRI scanners, which involve using a full-size replica scanner for a 5-minute training session to lie still, have been used to help explain to children what the procedure involves and what to expect in an age appropriate manner. This preparation has been reported to reduce MRI-related procedural anxiety, rate of motion artifacts, need for sedation, overall duration of the study, as well as a decrease in heart rate during the procedure. However, a shortcoming of mock replica is that there is limited availability in hospitals, since the mock MRI machine would require a room to store, as well as additional resources, including staff and time, to organize these sessions.

Virtual reality (VR) used to replicate an MRI environment can also be used as patient preparation. Indeed, VR has been used as preparation for chest radiography, dental procedures, anesthesia and surgeries. These studies show that VR preparation helped improve procedural experience among pediatric patients by reducing anxiety, distress and procedural time while increasing parents' satisfaction. VR is a distraction method that has been proven effective in reducing pain and anxiety in children in different settings, such as phlebotomy, wound care, chemotherapy, dental procedures and bone pins removal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Level of state-trait anxiety

时间窗: Change from Baseline (T0) at 15 minutes (T1) and at 30 minutes (T2)

Anxiety level will be measured using the State-Trait Anxiety Inventory for Children (French-Canadian Version) (STAIC-F), a 40-item questionnaire separated equally 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'' and 4 is ''Almost all the time''. 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.

Level of anxiety

时间窗: Change from Baseline (T0) at 15 minutes (T1) and at 45 minutes (T2)

Will also be assessed using the Child Fear Scale (CFS). 0 (no fear/anxiety) through 4 (extremely fearful/anxious).

次要结局

  • Level of State-trait anxiety in parents(Measured at Baseline (T0) and Measured at 45 minutes (T2))
  • Procedural time(Measured at 45 minutes (T2))
  • Sense of presence/engagement(Measured after in intervention - 15 minutes (T1))
  • Children's satisfaction(Measured at 45 minutes (T2))
  • Healthcare professional's satisfaction(Measured at 45 minutes (T2))
  • Occurrence of side effects(Measured at 45 minutes (T2))
  • Number of rescheduled MRI(Measured at 45 minutes (T2))
  • 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 has ended at 15 minutes (T1), and measured after the MRI at 45 minutes (T2))
  • Oxygen Saturation(Measured at baseline (T0), immediately after the VR intervention has ended at 15 minutes (T1), and measured after the MRI at 45 minutes (T2))
  • Parent's satisfaction(Measured at 45 minutes (T2))
  • Physiological measurement of anxiety (Alpha-Amylase)(Measured at Baseline (T0) and Measured at 45 minutes (T2))

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvie Le May

Principal Investigator

St. Justine's Hospital

研究点 (2)

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