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:

  1. Compare patients' feelings / opinions: patients who have benefited from hypnosis associated with MEOPA versus patients who have been treated with MEOPA alone.
  2. Compare patient stress: patients who have benefited from hypnosis associated with MEOPA versus patients who have benefited from MEOPA alone.
  3. Compare the operators' feelings / opinions: procedures that have been performed under hypno-analgesia and MEOPA versus standard procedures under MEOPA alone.
  4. Failed the TEE procedure

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Strasbourg, France, 67091
        • CHU Strasbourg - France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2020

Primary Completion (Actual)

October 14, 2020

Study Completion (Actual)

August 12, 2022

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

June 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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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