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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Utility of Hypnosis for Transesophageal Echocardiography

Resource links provided by NLM:

Drug Information available for: Lidocaine
U.S. FDA Resources

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

Primary Outcome Measures:
  • Level of patient comfort [ Time Frame: at Day 0 ] [ Designated as safety issue: No ]
    Visual Analogic Scale


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 170
Study Start Date: May 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095705

Contacts
Contact: François TOURNOUX, MD 01 49 95 82 25 francois.tournoux@lrb.aphp.fr

Locations
France
Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler Not yet recruiting
Paris, France, 75010
Contact: François TOURNOUX, MD     01 49 95 82 25     francois.tournoux@lrb.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: François TOURNOUX, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: VACHER Yannick, Department of clinical research and development
ClinicalTrials.gov Identifier: NCT01095705     History of Changes
Other Study ID Numbers: P090802, 2009-A01156-51
Study First Received: March 29, 2010
Last Updated: April 30, 2010
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013