Impact of Hypnosis During Invasive Procedure in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Pain distress
研究概览
简要总结
Pain during ICU stay remains one of the major complaints for patients. Beside pain intensity, well described by patients' self reports, pain distress, which is an emotional experience, cannot be treated with usual analgesia. The aim of the study is to analyze the impact of hypnosis on pain intensity and distress on short and long term outcomes in non-sedated ICU patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years and older
- •ICU hospitalisation
- •Non-sedated patients who need an invasive procedure (Invasive procedures are defined as chest tube (insert or remove), fibroscopy, catheter insert, lumbar punction and bone marrow aspiration)
- •Physician experienced in hypnosis available
- •written informed consent
- •health insurance
排除标准
- •sedation and intubation, delirium, end-of-life decision,
- •deaf patient,
- •patient who does not understand French language,
- •pregnancy
- •patient under guardianship or curatorship
- •lack of health insurance
研究组 & 干预措施
Patients who receive hypnosis
Patients who receive hypnosis during procedure by experiment physician
干预措施: Hypnosis group (Other)
Control arm
Patient with conventional pain management
结局指标
主要结局
Pain distress
时间窗: within the before and the first hour after the procedure
Pain distress change in the hypnosis group measured before and within the first hour after the procedure. Pain distress will be assessed using Numeric rating scale, which goes from 0 (no pain stress) to 10 (maximum pain stress).
次要结局
- Number of adverse events(during procedure)
- Analgesia dose(within first and 24 hours after procedure)
- Hospital Anxiety and Depression (HAD) scale(at 3 months)
- Proportion of patients who had hypnosis transe(during procedure)
- Pain intensity(within first hour and first 24 hours after procedure)
- Post traumatic stress disorder assessed using Impact of Event Scale Revisited (IES R)(at 3 months)
- Anxiety(within first and 24 hours after procedure)
- Length of each painful procedure(up to 3 months)
- Type of analgesia(within first and 24 hours after procedure)
- Description of the experience of hypnosis(at 3 months)