Hypnosis for Transesophageal Echocardiography

Not Applicable

Completed

• Conditions: Discomfort
• Interventions: Procedure: Conventional procedure; Procedure: Conventional procedure + Hypnosis

• Registration Number: NCT01095705
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2010-03
• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Study Start: 2010-05
• Primary Completion: 2010-11
• Study Completion: 2011-02
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional procedure	Conventional procedure	Local anaesthesia (Lidocaïne)
Conventional procedure + Hypnosis	Conventional procedure + Hypnosis	Local anaesthesia (Lidocaïne) and Hypnosis

Primary Outcome Measures

Name	Time	Method
Level of patient comfort	at Day 0	Visual Analogic Scale

Secondary Outcome Measures

Name	Time	Method
Quality of the procedure as assessed by the operator	at Day 0
Rate of procedure failure or non-diagnostic study	at Day 0
Duration of the procedure	at Day 0

Trial Locations

Locations (1)

Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler; 🇫🇷 Paris, France