Evaluation of a Music and Interaction Intervention on Patient Distress During Whole Body Magnetic Resonance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition.
研究概览
简要总结
This is a randomized controlled trial for the evaluation of the acceptability of Whole-Body-Magnetic Resonance Imaging (WB-MRI) based on music and comunication intervention compared to a standard care condition.
Subjects will be randomized into two groups: the experimental group or arm that receives the music and interaction interventions, and the control group or arm that receives a standard care condition.
详细描述
This study is a randomized controlled trial. Subjects referring to the European Institute of Oncology (IEO) and will undergo to WB-MRI for detection, staging, therapy monitoring or screening, will be asked to participate to the study and signed the informed consent.
Subjects will be divide into two groups: the experimental group or arm that receives the music and interaction interventions, and the control group or arm that receives a standard care condition.
The experimental group before the WB-MRI examination, complete distress Thermometer and received verbal information about the procedure from one of TRSM trained, during the examination subjects he has the opportunity to listen to the music of his choice and TRSM interacts with the subject four times to know he feels well. Before the examination control group complete distress Thermometer.
After examination both groups will be asked to complete a different WB-MRI acceptability questionnaire and distress Thermometer.
WB-MRI acceptability questionnaire is ad hoc questionnaire create to evaluate the acceptability of the WB-MRI based on of the interventions carried out.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who will undergo to WB-MRI for detection, staging, therapy monitoring or screening.
- •Acceptance and signature of informed consent.
排除标准
- •Any contra-indication to MRI examination (for example, pacemaker, in the first trimester of pregnancy, metal implants, etc.).
- •Anxiety disorder and psychological or pharmacological treatments for anxiety
结局指标
主要结局
Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition.
时间窗: 1 week
Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition. The evaluation of the acceptability of WB-MRI will be done in both groups using an ad hoc WB-MRI acceptability questionnaire created to evaluate the acceptability of the WB-MRI based on of the interventions carried out
次要结局
- Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020)(1 week)