Cardiac DiseasesHYPNETONCT04398017
MEOPA-coupled Hypnosis Versus MEOPA-standard Care in Transesophageal Echocardiography
A study testing Transesophageal echography in people with Cardiac Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Diseases
- What is being tested?
- Transesophageal echography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2020to 12 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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
- Conditions
- Cardiac Diseases
- Being tested
- Transesophageal echography
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal echographyProcedure or surgery
Ultrasound examination of the heart using a soft tube. The extremity is inserted through the mouth and positioned in the esophagus behind the heart.
| Study group | Role | What they receive |
|---|---|---|
| Standard support | Active comparator | Not described Receives: Procedure: Transesophageal echography |
| Hypnosis | Experimental | Not described Receives: Procedure: Transesophageal echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concomitant Measure of Pain and Anxiety
Measurements are made according to self-evaluation scales
Measured: Change from baseline Concomitant Measure of Pain and Anxiety at 10 minutes transesophageal echography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start14 Oct 2020
- Primary completion14 Oct 2020
- Study completion12 Aug 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398017
- Sponsor's protocol ID
- 7351
- Acronym
- HYPNETO
- Status last verified
- Jun 2023
- First submitted
- 22 Jan 2020
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04398017
- Acronym / sponsor ID
- HYPNETO / 7351
- Conditions
- Cardiac Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard support | Active comparator | Procedure: Transesophageal echography |
| Hypnosis | Experimental | Procedure: Transesophageal echography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal echographyUltrasound examination of the heart using a soft tube. The extremity is inserted through the mouth and positioned in the esophagus behind the heart. | Procedure or surgery | Hypnosis, Standard support |
Primary outcome
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
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transesophageal echography in people with Cardiac Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concomitant Measure of Pain and Anxiety (time frame: Change from baseline Concomitant Measure of Pain and Anxiety at 10 minutes transesophageal echography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.