The Effects of Body Scan on Enteroception in Patients with Heart Failure: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Enteroceptive sensibility
研究概览
简要总结
The study aims to explore the effects of body scan on enteroception in people with heart failure
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Heart Failure
- •Italian speaking
- •Willing to sign the Informed Consent Form
排除标准
- •Cognitive Impairment documented in the medical records
研究组 & 干预措施
Experimental group
The experimental group will receive a body scan intervention. Body scan is a guided meditation technique that allows people to detect signs and signals from their body (for instance, heart rate).
The intervention will last 20 minutes and will be performed 21 consecutives days. The first and last days it will be performed in presence, while the other ones online.
干预措施: Body Scan (Behavioral)
Control group
The control group will not receive the intervention, but only standard care
结局指标
主要结局
Enteroceptive sensibility
时间窗: At 1 month after the end of the body scan intervention
Enteroceptive Sensibility (assessed with the Multidimensional Assessment of Interoceptive Awareness, version 2, MAIA-2) The MAIA-2 is a 6-point Likert scale questionnaire with 37 items divided into 8 subscales. Higher scores reflect greater enteroceptive sensibility.
次要结局
- Enteroceptive Sensibility(At 3, 6, and 9 month after the end of the intervention)
- Enteroceptive Accuracy(At baseline, 1, 3, 6, and 9 months after the end of the intervention)
- Enteroceptive Awareness(At baseline, after 1, 3, 6, and 9 months after the end of the intervention)
- Symptoms Perception(At baseline, 1, 3, 6, and 9 months after the end of the intervention)
- Generic Quality of Life(At baseline, 1, 3, 6, and 9 months after the end of the intervention)
- Heart Failure Specific Quality of Life(At baseline, 1, 3, 6, and 9 months after the end of the intervention)
- Self-care(At baseline, 1, 3, 6, and 9 months after the end of the intervention)
- Self-care Self-efficacy(At baseline, 1, 3, 6, and 9 months after the end of the intervention)
- Anxiety(At baseline, 1, 3, 6, and 9 months after the end of the intervention)
- Depression(At baseline, 1, 3, 6, and 9 months after the end of the intervention)
- Alexithymia(At baseline, 1, 3, 6, and 9 months after the end of the intervention)
- Emotional Regulation(At baseline, 1, 3, 6, and 9 months after the end of the intervention)
研究者
Alessia Trenta
Dr
Centro Cardiologico Monzino