Evaluation of the Benefits of Hypnosis During Transoesophageal Echocardiography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- the degree of comfort felt during the procedure, measured on a visual analogue scale (VAS) (from 0 to 10) immediately after the examination
研究概览
简要总结
Transoesophageal echocardiography (TOE) is a routine cardiology examination that is performed in most cases under local anaesthesia and is recommended for many indications.The objective of our study will be to evaluate the expected beneficial effect of using conversational hypnosis and hypnosis during a transoesophageal ultrasound examination performed directly in the examination room by the cardiologist conducting the examination.
详细描述
Transoesophageal echocardiography is a routine cardiology examination that is performed in most cases under local anaesthesia and is recommended for a number of indications: stroke assessment, endocarditis screening, and heart valve evaluation. It involves inserting an ultrasound probe into the oesophagus through the patient's mouth in order to see the heart more closely and from a different angle. It is a useful and necessary examination in certain situations, but it can be uncomfortable for patients despite local anaesthesia. The examination can be performed under general anaesthesia, but this carries a risk of adverse effects (between 5 and 6%) for the patient and requires more extensive care (anaesthetist, prolonged monitoring during recovery).
The objective of our study will be to evaluate the expected beneficial effect of using conversational hypnosis and hypnosis during a transoesophageal ultrasound examination performed directly in the examination room by the cardiologist conducting the examination. The cardiologist will use the unavoidable time required to set up and explain the examination to use conversational hypnosis and will take additional, deliberately shortened time to perform 'light' hypnosis. The effectiveness of the combined use of a conversational hypnosis phase and a hypnosis phase will be compared, in terms of tolerance of the examination and time consumed, to a 'classic' interview conducted by a cardiologist not trained in these two techniques. In both situations, the explanation given to the patient will be complete and adapted to each patient's level of understanding and will be provided before the patient is in a state of hypnosis. If we can show that by using the necessary and unavoidable time to explain the examination to the patient, we can use conversational hypnosis and hypnosis techniques to improve the patient's comfort without excessive loss of time (>15 minutes) or the need for additional staff, this would highlight the value of using these techniques in daily practice and the expected benefits of training healthcare professionals.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged ≥ 18 years old
- •Patient requiring a transoesophageal ultrasound scan under local anaesthetic.
- •Patient affiliated to a health insurance scheme
- •French-speaking patient
- •Patient who has given their free, informed and express verbal consent
排除标准
- •Patient with a contraindication to transoesophageal ultrasound (significant radiation exposure to the chest, oesophageal pathology with risk of bleeding)
- •Patients with known schizophrenia or known psychiatric illness (documented in medical records)
- •Patients with known dementia or known cognitive impairment (documented in medical records)
- •Patients already included in an interventional research protocol
- •Patients under guardianship or curatorship
- •Patients deprived of their liberty
- •Patients under judicial protection
- •Pregnant or breastfeeding patients
研究组 & 干预措施
hypnosis' experimental group
For the 'hypnosis' experimental group, the examination will be carried out in the usual room. Local anaesthesia will be administered by a nurse. A first cardiologist (a doctor trained in hypnosis) will be present to explain the procedure to the patient using conversational hypnosis. Once all the information has been provided and understood, he will use hypnosis to attempt to induce a trance (see section 1.4, procedure performed). A second cardiologist (operator) will perform the examination. As in the control group, the cardiologist trained in hypnosis will assist the operating cardiologist during the examination and may perform the examination himself if the first operator fails.
干预措施: conversational hypnosis (Other)
control group
For the control group, the examination will be performed according to standard practice. A nurse will administer local anaesthesia to the throat, then a first cardiologist (operator) will inform the patient about the examination procedure and perform the examination. A second cardiologist will assist the first operator and may perform the examination themselves if the first operator is unsuccessful after three attempts.
结局指标
主要结局
the degree of comfort felt during the procedure, measured on a visual analogue scale (VAS) (from 0 to 10) immediately after the examination
时间窗: 1 day
The main evaluation criterion is the degree of comfort felt during the operation, measured on a visual analogue scale (VAS) (from 0 to 10) immediately after the examination. The question asked will be 'During the procedure, how comfortable were you?'
次要结局
未报告次要终点