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Hypnosis for Transesophageal Echocardiography (I-SLEPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01095705
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : December 19, 2013
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Discomfort Procedure: Conventional procedure Procedure: Conventional procedure + Hypnosis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Utility of Hypnosis for Transesophageal Echocardiography
Study Start Date : May 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : February 2011

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)

Primary Outcome Measures :
  1. Level of patient comfort [ Time Frame: at Day 0 ]
    Visual Analogic Scale

Secondary Outcome Measures :
  1. Rate of procedure failure or non-diagnostic study [ Time Frame: at Day 0 ]
  2. Duration of the procedure [ Time Frame: at Day 0 ]
  3. Quality of the procedure as assessed by the operator [ Time Frame: at Day 0 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01095705

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Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: François TOURNOUX, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01095705     History of Changes
Other Study ID Numbers: P090802
2009-A01156-51 ( Other Identifier: IDRCB )
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: March 2010

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Transesophageal Echocardiography
Efficiency of Hypnosis

Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action