Hypnosis for Transesophageal Echocardiography

Study Overview
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Brief Summary
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The purpose of this study is to determine the additive value of hypnosis to improve patient comfort during transesophageal echocardiography (TEE).

Detailed Description
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TEE is a widely used diagnostic test in cardiovascular medicine. However, the test may be a source of discomfort to the patient. Patient intolerance of the echocardiography probe limits the duration of the procedure and therefore its diagnostic success. Current strategies to reduce patient discomfort involve global anesthesia, which carries its own side effects and risks of adverse events. Hypnosis may reduce patient discomfort without impairing alertness. The main goal of this study is to determine the additive value of hypnosis to improve patient comfort during TEE.

Official Title
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Utility of Hypnosis for Transesophageal Echocardiography

Conditions
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Discomfort

Intervention / Treatment
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* Procedure: Conventional procedure
* Procedure: Conventional procedure + Hypnosis


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patient with indication for a Transesophageal Echo (TEE) Patient competent to provide written informed consent Exclusion criteria: Patient not subscribed to French Social Security System Patient non-French speaking Age < 18 years Follow-up not possible patient declared non competent to give informed consent for the study History of severe personality disorder Patient with a psychiatric treatment started 30 days before the exam Patient pregnant or breast-feeding Emergency TEE Other indication for general anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional procedure<br>Local anaesthesia (Lidocaïne) | Procedure: Conventional procedure<br>* Local anaesthesia (Lidocaïne)<br>|
| Experimental: Conventional procedure + Hypnosis<br>Local anaesthesia (Lidocaïne) and Hypnosis | Procedure: Conventional procedure + Hypnosis<br>* Local anaesthesia (Lidocaïne) + Hypnosis (20 minutes)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of patient comfort | Visual Analogic Scale | at Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of procedure failure or non-diagnostic study |  | at Day 0 | 
| Duration of the procedure |  | at Day 0 | 
| Quality of the procedure as assessed by the operator |  | at Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypnosis, Transesophageal Echocardiography, Efficiency of Hypnosis