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TerminatedNCT04398017HYPNETOUpdated Jun 5, 2023

MEOPA-coupled Hypnosis Versus MEOPA-standard Care in Transesophageal Echocardiography

An interventional study of Transesophageal echography in Cardiac Diseases, sponsored by University Hospital, Strasbourg, France. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-05.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Treatment

Why this study was terminated
The early termination is due to an impossibility to include new candidates due to the degraded functioning of the service in connection with a chronic paramedical decrease in the number of caregivers trained in hypnosis.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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
02

Conditions studied

  • Cardiac Diseases

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03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 80 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

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Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Standard support

    Procedure: Transesophageal echography

  • Experimental
    Hypnosis

    Procedure: Transesophageal echography

Interventions

  • ProcedureTransesophageal echography

    Ultrasound examination of the heart using a soft tube. The extremity is inserted through the mouth and positioned in the esophagus behind the heart.

06

What researchers measure

Primary outcomes

  1. Concomitant Measure of Pain and Anxiety

    Measurements are made according to self-evaluation scales

    Time frame: Change from baseline Concomitant Measure of Pain and Anxiety at 10 minutes transesophageal echography

07

Study locations

1 site
  • CHU Strasbourg - France
    Strasbourg, 67091, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04398017
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
May 21, 2020
Start date
Oct 14, 2020
Primary completion
Oct 14, 2020
Completion
Aug 12, 2022
Last update
Jun 5, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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