Status:
TERMINATED
MEOPA-coupled Hypnosis Versus MEOPA-standard Care in Transesophageal Echocardiography
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Cardiac Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary purpose is to evaluate the impact of hypnosis coupled with MEOPA (Equimolar Mix-ture of Nitrogen Protoxide and Oxygen) on patient comfort when performing transoesophageal echocardiographie...
Eligibility Criteria
Inclusion
- Patient (male or female) of full age without upper age limit
- Patient hospitalized on the site of the Nouvel Hôpital Civil - Strasbourg, with an indication of transesophageal echography with a diagnostic purpose of a cardiac pathology (transesophageal echography scheduled the day after or the very day of selection)
- Patient affiliated to a social security health insurance scheme
- Patient able to understand the objectives and risks related to the research and to give an informed consent dated and signed
- For a woman of childbearing age: negative blood pregnancy test (test performed by the service as part of the care or diagnostic and therapeutic needs related to the patient's hospitalization).
Exclusion
- Patient with a contraindication to the use of MEOPA
- Patient with little or no understanding of French
- Patient with hearing problems that do not allow hypnosis to occur
- Patient with psychiatric disorders (schizophrenia, psychosis, melancholic depression, hysteria...)
- Disoriented patients
- Patient receiving the following treatments/management:
- ophthalmic gas centrally acting drugs: opiates, benzodiazepines and other psychotropic drugs (potentiation of effects).
- Long-term anxiolytics
- Premedications for transesophageal echocardiography by analgesics, Benzodiazepine, hydroxizine, antiemetics and gastric prokinetics or gabapentinoïdes (gabapentin, pregabaline)
- Psychocorporal therapies or complementary therapies during the period of hospitalization (psychotherapy, meditation, acupuncture...)
- Patient in exclusion period (determined by a previous or ongoing study),
- Impossibility of giving the patient informed information (patient in an emergency situation, difficulties in understanding, etc.)
- Pregnancy or breastfeeding reported by the patient
- Patients under curatorship, guardianship, protection of justice
- If the patient has an VAPS \>8/10, the transesophageal echocardiography procedure and therefore its inclusion in the research will be postponed.
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04398017
Start Date
October 14 2020
End Date
August 12 2022
Last Update
June 5 2023
Active Locations (1)
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1
CHU Strasbourg - France
Strasbourg, France, 67091