Hôpital Paris Saint Joseph
Paris, Île-de-France Region, 75014, France
Location status: Recruiting
NCT Number: NCT07512830
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, Île-de-France Region, 75014, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient aged ≥ 18 years old
Exclusion criteria
Patient with a contraindication to transoesophageal ultrasound (significant radiation exposure to the chest, oesophageal pathology with risk of bleeding)
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 the examination and may perform the examination himself if the first operator fails.
Time frame: 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?'
Contact information is provided by the study sponsor or research team.
Fondation Hôpital Saint-Joseph
Other
Acronym: HYPNOECHO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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