We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hypnosis for Transesophageal Echocardiography (I-SLEPT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01095705
First Posted: March 30, 2010
Last Update Posted: December 19, 2013
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.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
The purpose of this study is to determine the additive value of hypnosis to improve patient comfort during transesophageal echocardiography (TEE).

Condition Intervention
Discomfort Procedure: Conventional procedure Procedure: Conventional procedure + Hypnosis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Utility of Hypnosis for Transesophageal Echocardiography

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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


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

Enrollment: 101
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01095705


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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01095705     History of Changes
Other Study ID Numbers: P090802
2009-A01156-51 ( Other Identifier: IDRCB )
First Submitted: March 29, 2010
First Posted: March 30, 2010
Last Update Posted: December 19, 2013
Last Verified: March 2010

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

Additional relevant MeSH terms:
Anesthetics
Lidocaine
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