Evaluation of the Benefits of Hypnosis During Transoesophageal Echocardiography

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое conversational hypnosis
  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). A second cardiologist (operator) will perform the examination. As in the control group, the cardiologist trained in hypnosis will assist the operating cardiologist during

Первичные конечные точки

• the degree of comfort felt during the procedure, measured on a visual analogue scale (VAS) (from 0 to 10) immediately after the examination [Срок оценки: 1 day]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Hôpital Paris Saint Joseph — Paris

Идентификаторы

NCT: NCT07512830 · HYPNOECHO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗