Hypnosis for Transesophageal Echocardiography

Discomfort Clinical Trial

— I-SLEPT  

Official title:

Utility of Hypnosis for Transesophageal Echocardiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095705
• Other study ID #: P090802
• Secondary ID: 2009-A01156-51
• Status: Completed
• Phase: N/A
• First received: March 29, 2010
• Last updated: December 18, 2013
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: March 2010
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Discomfort

Intervention

Procedure:
• Conventional procedure
Local anaesthesia (Lidocaïne)
• Conventional procedure + Hypnosis
Local anaesthesia (Lidocaïne) + Hypnosis (20 minutes)

Locations

Country	Name	City	State
France	Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of patient comfort	Visual Analogic Scale	at Day 0	No
Secondary	Rate of procedure failure or non-diagnostic study		at Day 0	No
Secondary	Duration of the procedure		at Day 0	No
Secondary	Quality of the procedure as assessed by the operator		at Day 0	No