Hypnosis for Transesophageal Echocardiography (I-SLEPT)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2010 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01095705

First received: March 29, 2010

Last updated: April 30, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 29, 2010

Last Updated Date

April 30, 2010

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Level of patient comfort [ Time Frame: at Day 0 ] [ Designated as safety issue: No ]

Visual Analogic Scale

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01095705 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rate of procedure failure or non-diagnostic study [ Time Frame: at Day 0 ] [ Designated as safety issue: No ]
Duration of the procedure [ Time Frame: at Day 0 ] [ Designated as safety issue: No ]
Quality of the procedure as assessed by the operator [ Time Frame: at Day 0 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hypnosis for Transesophageal Echocardiography

Official Title ^ICMJE

Utility of Hypnosis for Transesophageal Echocardiography

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Discomfort

Intervention ^ICMJE

Procedure: Conventional procedure
Local anaesthesia (Lidocaïne)
Procedure: Conventional procedure + Hypnosis
Local anaesthesia (Lidocaïne) + Hypnosis (20 minutes)

Study Arm (s)

Active Comparator: Conventional procedure
Local anaesthesia (Lidocaïne)

Intervention: Procedure: Conventional procedure
Experimental: Conventional procedure + Hypnosis
Local anaesthesia (Lidocaïne) and Hypnosis

Intervention: Procedure: Conventional procedure + Hypnosis

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

170

Estimated Completion Date

December 2010

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: François TOURNOUX, MD

01 49 95 82 25

francois.tournoux@lrb.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01095705

Other Study ID Numbers ^ICMJE

P090802, 2009-A01156-51

Has Data Monitoring Committee

Responsible Party

VACHER Yannick, Department of clinical research and development

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

François TOURNOUX, MD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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