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Hypnosis for Transesophageal Echocardiography

NCT ID: NCT01095705

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-02-28

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.

Conditions

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Discomfort

Keywords

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Hypnosis Transesophageal Echocardiography Efficiency of Hypnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Conventional procedure

Local anaesthesia (Lidocaïne)

Group Type ACTIVE_COMPARATOR

Conventional procedure

Intervention Type PROCEDURE

Local anaesthesia (Lidocaïne)

Conventional procedure + Hypnosis

Local anaesthesia (Lidocaïne) and Hypnosis

Group Type EXPERIMENTAL

Conventional procedure + Hypnosis

Intervention Type PROCEDURE

Local anaesthesia (Lidocaïne) + Hypnosis (20 minutes)

Interventions

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Conventional procedure

Local anaesthesia (Lidocaïne)

Intervention Type PROCEDURE

Conventional procedure + Hypnosis

Local anaesthesia (Lidocaïne) + Hypnosis (20 minutes)

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François TOURNOUX, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2009-A01156-51

Identifier Type: OTHER

Identifier Source: secondary_id

P090802

Identifier Type: -

Identifier Source: org_study_id