Evaluation of the Benefits of Hypnosis During Transoesophageal Echocardiography
ConditionCardio Vascular Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondation Hôpital Saint-Joseph
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
conversational hypnosis
Other interventionLocal 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: hypnosis' experimental groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
the degree of comfort felt during the procedure, measured on a visual analogue scale (VAS) (from 0 to 10) immediately after the examination
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?'
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov