Back to resultsMEOPA-coupled Hypnosis Versus MEOPA-standard Care in Transesophageal Echocardiography (HYPNETO)
Primary Purpose
Cardiac Diseases
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transesophageal echography
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Diseases
Eligibility Criteria
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.
Sites / Locations
- CHU Strasbourg - France
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard support
Hypnosis
Arm Description
Outcomes
Primary Outcome Measures
Concomitant Measure of Pain and Anxiety
Measurements are made according to self-evaluation scales
Secondary Outcome Measures
Full Information
NCT ID
NCT04398017
First Posted
January 22, 2020
Last Updated
June 1, 2023
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT04398017
Brief Title
MEOPA-coupled Hypnosis Versus MEOPA-standard Care in Transesophageal Echocardiography
Acronym
HYPNETO
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
October 14, 2020 (Actual)
Study Completion Date
August 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard support
Arm Type
Active Comparator
Arm Title
Hypnosis
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Transesophageal echography
Intervention Description
Ultrasound examination of the heart using a soft tube. The extremity is inserted through the mouth and positioned in the esophagus behind the heart.
Primary Outcome Measure Information:
Title
Concomitant Measure of Pain and Anxiety
Description
Measurements are made according to self-evaluation scales
Time Frame
Change from baseline Concomitant Measure of Pain and Anxiety at 10 minutes transesophageal echography
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU Strasbourg - France
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Learn more about this trial
MEOPA-coupled Hypnosis Versus MEOPA-standard Care in Transesophageal Echocardiography
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