Hypnosis for Transesophageal Echocardiography (I-SLEPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01095705
First received: March 29, 2010
Last updated: December 18, 2013
Last verified: March 2010
  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

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 ]

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01095705     History of Changes
Other Study ID Numbers: P090802, 2009-A01156-51
Study First Received: March 29, 2010
Last Updated: December 18, 2013
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 September 22, 2014