- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07512830
Evaluation of the Benefits of Hypnosis During Transoesophageal Echocardiography (HYPNOECHO)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yoann MOEUF, medical doctor
- Phone Number: +33 01-44-12-62-44
- Email: ymoeuf@ghpsj.fr
Study Locations
-
-
Île-de-France Region
-
Paris, Île-de-France Region, France, 75014
- Recruiting
- Hôpital Paris Saint Joseph
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the degree of comfort felt during the procedure, measured on a visual analogue scale (VAS) (from 0 to 10) immediately after the examination
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?'
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yoann MOEUF, medical doctor, Hospital Paris Saint Joseph
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYPNOECHO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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