Effects of Virtual Reality MRI Preparedness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Participants with Successful Imaging without Sedation
研究概览
简要总结
Magnetic resonance imaging is an important and increasingly prevalent imaging modality used in healthcare. Children often find the procedure anxiety provoking causing difficulty in staying still and providing quality images. The use of preparation techniques including play therapy and role play utilizing such tools as a fiberglass mock MRI have shown to reduce anxiety and facilitate better image quality. Modalities of preparation including Virtual Reality (VR) pose as an alternative to habituate children for a MRI procedure.
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 (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is between the ages of 8-9 years inclusive
- •Child scheduled for a clinical MRI at CHLA.
排除标准
- •Child is younger than 8 years or older than 9 years. These are the bottom end of age ranges that are frequently sedated.
- •Children who have metal in their bodies that cannot participant in an MRI.
- •Medical history that may affect brain development that may confound ability to complete an MRI without sedation.
- •Children suffering from epilepsy or history of seizures who may react poorly to a virtual reality intervention.
- •Child who has a history of MRI acquisition where habituation and preparedness may not be needed.
- •Child with English as a second language due to restrictions of research team.
- •Child with implantable medical devices or personal medical devices that may be affected by the study device's radio waves
研究组 & 干预措施
Standard of Care (No VR) Randomization
Participants would take the same questionnaires as the VR interventional group except the RT questionnaire. Then they will proceed with their MRI.
VR Randomization
The virtual reality MRI training will be conducted immediately after completion of the questionnaires in a distraction free room. The training explains the procedure to the viewer and addresses common questions that individuals often have regarding an MRI. Using audio/visual cues and biofeedback training is aimed to mimic the experience of the MRI with real audio recordings of image acquisition, in order to adequately train the view to stay still in an MRI procedure. The research subject will continue with their regularly scheduled MRI. The modified Yale Preoperative Anxiety Scale (mYPAS) is an observational measure and will be completed by research staff.
干预措施: Pico G2 4k (Device)
结局指标
主要结局
Number of Participants with Successful Imaging without Sedation
时间窗: Up to thirty minutes after intervention
A successful image will be produced after MRI. Failure would mean the child is rescheduled for another MRI with sedation.
Faces Pain Scale-Revised (FPS-R)
时间窗: Approximately 5 minutes to one hour before procedure
Revised is an updated version of the Wong-Baker Faces Pain Rating Scale depicting no pain as a neutral expression as compared with the smiling face of the original measure. The child is asked to point to the face cartoon that depicts how they are currently feeling because of their pain. Face measures are thought to measure pain intensity, and the Wong-Baker Faces measure has demonstrated good reliability and validity.
Child Anxiety Meter State (CAM-S)
时间窗: Approximately 5 minutes to one hour before procedure
The child is asked to color a thermometer that has ten marks to indicate their level of anxiety they feel at the moment. The meter can be translated to a 0-10 scale with higher score indicating greater anxiety.
Childhood Anxiety Sensitivity Index (CASI)
时间窗: Approximately 5 minutes to one hour before procedure
This 18-item measure utilizes a three-point Likert scale (none (1), some (2), a lot (3)) to assess how negatively patients view anxiety symptoms. Items are summed with a higher score indicating greater anxiety sensitivity.
Visual Analogue Scale (VAS)
时间窗: Approximately 5 minutes to one hour before intervention
The VAS anticipatory anxiety measure is a vertical VAS, anchored with 0 at the bottom indicating the least amount and 10 at the top indicating the greatest amount, in response to the instruction to rate "how nervous, afraid, or worried" they were about the upcoming task. The scale also has color cues, graded from yellow at the bottom to dark red at the top, as well as a neutral face at the bottom and a face showing a negative expression at the top. Prior research used the VAS to rate anticipatory anxiety and pain in children
Child Anxiety Meter Trait (CAM-T)
时间窗: Approximately 5 minutes to one hour before procedure
The child is asked to color a thermometer that has ten marks to indicate their level of anxiety they usually feel at home. The meter can be translated to a 0-10 scale with higher score indicating greater anxiety.
次要结局
- Demographics(Up to one hour before intervention)
研究者
Jeffrey I Gold, PhD
Principal Investigator
Children's Hospital Los Angeles