NCT02867644终止不适用
Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking
Institut de Cancérologie de Lorraine10 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2016年11月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 171
- 试验地点
- 10
- 主要终点
- Compare anxiety of patients undergoing for a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
研究概览
简要总结
The hypothesis is to assess the contribution of conversational hypnosis on anxiety of patients who undergoing for a preoperative breast tracking and improve their care
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients ≥ 18 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Patient undergoing for a preoperative breast assessment
- •Patient must be affiliated to a social security system
- •Ability to provide an informed written consent form
排除标准
- •Patients diagnosed with major hearing loss
- •Patients with schizophrenia
- •Patients do not understand the French language
- •Pregnant or breast feeding females
- •Refusal of the patient to participate in the study
- •Persons deprived of liberty or under supervision
结局指标
主要结局
Compare anxiety of patients undergoing for a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
时间窗: Day 1
The anxiety level will be assessed in each group by a visual analog scale from 0 to 10.
次要结局
- Evaluate the receptivity of women to conversational hypnosis(Day 1)
- Compare the pain felt by patients during a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)(Day 1)
- Assess the impact of conversational hypnosis on completion of the examination(Day 1)
- Compare the manipulator's satisfaction during a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)(Day 1)
研究者
研究点 (10)
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