Hypnosis for Transesophageal Echocardiography (I-SLEPT)

December 18, 2013 updated by: Assistance Publique - Hôpitaux de Paris

Utility of Hypnosis for Transesophageal Echocardiography

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional procedure
Local anaesthesia (Lidocaïne)
Procedure: Conventional procedure
Local anaesthesia (Lidocaïne)
Experimental: Conventional procedure + Hypnosis
Local anaesthesia (Lidocaïne) and Hypnosis
Procedure: Conventional procedure + Hypnosis
Local anaesthesia (Lidocaïne) + Hypnosis (20 minutes)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: François TOURNOUX, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (Estimate)

March 30, 2010

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P090802
  • 2009-A01156-51 (Other Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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