Efficacy of Virtual Reality Based Simulation in the Preparation of Children for Magnetic Resonance Imaging Examinations: a Randomized Clinical Trial (MRVR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- proportion of children requiring anesthesia
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate whether a virtual reality based preparation method can efficiently decrease the proportion of children requiring general anesthesia during MRI examinations.
Participants will take part in a virtual reality environment resembling an MRI before their scheduled MRI examination.
Researchers will compare these children to usual care and a booklet based preparation method to see if less children need anesthesia for completing the MRI examination.
详细描述
Study Description:
Our study investigates the efficacy of a custom-made virtual reality experience in the preparation of children for MRI examinations. We hypothesise that preparation with VR can significantly reduce the need for anesthesia in children during MRI examinations, or if anesthesia is needed less doses of anesthetics are required.
Objectives:
Primary Objective:
To evaluate whether the VR based preparation decreases the need for anesthesia and sedation during MRI examinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants cannot be blinded due to the nature of the study. The radiologists, anesthesiology team, MRI staff and the second research assistant administering post-procedure questionnaires and coding anesthesiology data intended to be blinded, however, children may disclose their group by talking about their experience.
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed assent and parental informed consent to participate in the study.
- •Stated willingness to participate in the intervention and to complete study questionnaires.
- •Inpatient or outpatient at the Pediatric Center.
- •Age 4-18 years
- •Scheduled for MRI examination under anesthesia at the Semmelweis University.
- •Fluent in Hungarian language
排除标准
- •Severe visual impairment or hearing loss that would hinder the participation of the VR and booklet experience.
- •In case of epilepsy, if the treating physician recommend against participation.
- •Children with severe intellectual disability which would hinder participation in the VR group e.g. not able to follow simple instructions.
- •Inpatients, if the treating physician indicates that the child is too unwell for the study.
- •Face or cranial deformities, wounds on the face and head which would hinder wearing the VR headset.
研究组 & 干预措施
VR
Participants in the VR group are immersed in a unique 360° VR experience specifically designed for this study.
The custom made VR experience consists of two parts. In the first part, children find themselves in a simulated MRI room which resembles to the one they will be scanned.
The second half of the VR experience introduces a mindfulness-ACT based meditation segment within the context of a space travel.
干预措施: VR (Other)
Booklet
Children in the booklet condition will be prepared by using an educational booklet containing colorful illustrations of the MRI examination room and about the procedure. This serves as a resource to familiarize them with the MRI procedure, address common concerns, and provide information about what to expect during the exam. The role of the booklet condition is to serve as an active control for our experimental condition. This condition also contains an interaction with the experimenter and increases familiarity through explanation and illustrations. However, it does not involve the immersive effect of the VR.
干预措施: Booklet (Other)
Usual care
In the usual care condition children are prepared by the healthcare staff through explanations, reframing, playing as per personal preference which is currently the standard of care in our departments.
结局指标
主要结局
proportion of children requiring anesthesia
时间窗: during the MRI examination, assessed directly after the MRI from anesthesiology documentation
proportion of children requiring any form of anesthesia or sedation during the MRI examination
次要结局
- nervousness(directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination)
- willingness to take part again(no later than 4 hours after the MRI examination)
- fear(assessed directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination)
- mood(directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination)
- familiarity(directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination)
- helpfulness(directly before the MRI examination)
研究者
Dr. Horváth Klára
assistant professor
Semmelweis University