Trials / Terminated
TerminatedNCT04398017
MEOPA-coupled Hypnosis Versus MEOPA-standard Care in Transesophageal Echocardiography
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.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- University Hospital, Strasbourg, France · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Transesophageal 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. |
Timeline
- Start date
- 2020-10-14
- Primary completion
- 2020-10-14
- Completion
- 2022-08-12
- First posted
- 2020-05-21
- Last updated
- 2023-06-05
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04398017. Inclusion in this directory is not an endorsement.