- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04398017
MEOPA-coupled Hypnosis Versus MEOPA-standard Care in Transesophageal Echocardiography (HYPNETO)
Randomized Trial Comparing the Use of MEOPA (Equimolar Mixture of Nitrogen Protoxide and Oxygen)-Coupled Hypnosis Versus MEOPA Standard Care of Pain and Anxiety During Transesophageal Echocardiography (TEE) in Conscious Patients.
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 echocardiographies.
Further studies on the use of MEOPA alone or the technique of hypnosis alone in the context of an TEE, would not be innovative in any way in view of previous studies or already in progress.
However, service has led to perform TEEs several times by combining MEOPA and hypnosis. Doctors noted a clear reduction in induction time for hypnosis and satisfaction of the patient and operators. This association technique is very often used in pediatrics.
According to one study, it seems that MEOPA increases the threshold of suggestibility and imagination. However suggestion and imagination are two essential notions of the hypnotic technique. To date, doctors have not found any other studies combining MEOPA and hypnosis for adults patients in the context of TEE.
This leads to the following hypothesis: Is there a difference for the patient in terms of for the global management of pain and anxiety between an TEE performed under MEOPA with a standard support and TEE under MEOPA coupled with hypnosis with support standard?
Secondary purposes are:
- Compare patients' feelings / opinions: patients who have benefited from hypnosis associated with MEOPA versus patients who have been treated with MEOPA alone.
- Compare patient stress: patients who have benefited from hypnosis associated with MEOPA versus patients who have benefited from MEOPA alone.
- Compare the operators' feelings / opinions: procedures that have been performed under hypno-analgesia and MEOPA versus standard procedures under MEOPA alone.
- Failed the TEE procedure
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Strasbourg, France, 67091
- CHU Strasbourg - France
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard support
|
Ultrasound examination of the heart using a soft tube.
The extremity is inserted through the mouth and positioned in the esophagus behind the heart.
|
Experimental: Hypnosis
|
Ultrasound examination of the heart using a soft tube.
The extremity is inserted through the mouth and positioned in the esophagus behind the heart.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concomitant Measure of Pain and Anxiety
Time Frame: Change from baseline Concomitant Measure of Pain and Anxiety at 10 minutes transesophageal echography
|
Measurements are made according to self-evaluation scales
|
Change from baseline Concomitant Measure of Pain and Anxiety at 10 minutes transesophageal echography
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 7351
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.
Clinical Trials on Cardiac Diseases
-
Ostfold University CollegeNot yet recruitingCardiac Arrest | Cardiac Arrhythmia | Cardiac Disease | Cardiac Death
-
Idoven 1903 S.L.Spanish Society of Cardiology; Fundación de Investigación en Red en Enfermedades...RecruitingCardiomyopathies | Cardiac Arrest | Sudden Cardiac Death | Cardiac ArrhythmiasSpain
-
Maastricht University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Getinge...CompletedCardiac Arrest | Sudden Cardiac Death | Out-Of-Hospital Cardiac ArrestNetherlands
-
Zoll Medical CorporationCompletedSudden Cardiac Death | Cardiac Event | Cardiac Arrythmias | Left Ventricular DysfunctionFrance
-
University of British ColumbiaRecruitingSurgery | Cardiac Event | Cardiac Disease | Cardiac Complication | Cardiac Valve Disease | Surgery-ComplicationsCanada
-
Charite University, Berlin, GermanyUnknownHeart Failure | Sudden Cardiac Death | Cardiac Resynchronisation TherapyGermany
-
Medical College of WisconsinUnknownHeart Arrest | Cardiac Arrest | Sudden Cardiac Death | Cardiopulmonary Arrest | Out of Hospital Cardiac ArrestUnited States
-
French Defence Health ServiceCompletedVentricular Fibrillation | Ventricular Tachycardia | Sudden Cardiac Death | Cardiac Arrest, SuddenFrance
-
Maastricht University Medical CenterJessa HospitalEnrolling by invitationVentricular Fibrillation | Heart Arrest | Ventricular Tachycardia | Cardiac Arrest | Congenital Heart Disease | Ventricular Arrythmia | Polymorphic Ventricular Tachycardia | Sudden Cardiac Death | Cardiac Arrhythmia | Cardiac Death | Sudden Cardiac Death Due to Cardiac Arrhythmia | Sudden Cardiac ArrestNetherlands
-
Seoul National University HospitalCompletedVentilation | Out-Of-Hospital Cardiac Arrest | Advanced Cardiac Life SupportKorea, Republic of
Clinical Trials on Transesophageal echography
-
Assistance Publique - Hôpitaux de ParisCompleted
-
University Hospital, LimogesCompletedChondrocalcinosis | Articular Cartilage CalcificationFrance
-
AstesCompleted
-
University Hospital, GrenobleCompleted
-
Centre Hospitalier Universitaire de BesanconNot yet recruiting
-
University Medical Center GroningenCompletedEmphysemaNetherlands
-
University Hospital, Strasbourg, FranceTerminatedType 2 Diabetes | Silent Myocardial IschemiaFrance
-
Hospital NordCompletedRespiratory Failure | Failure; CardiacFrance
-
Queen Mary Hospital, Hong KongNot yet recruiting
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingHeart Surgical ProcedureItaly