Hypnosis for Transesophageal Echocardiography (I-SLEPT)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Discomfort

Treatments: Procedure: Conventional procedure; Procedure: Conventional procedure + Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01095705

P090802

2009-A01156-51 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

Conventional procedure

Active Comparator group

Description:

Local anaesthesia (Lidocaïne)

Treatment:

Procedure: Conventional procedure

Conventional procedure + Hypnosis

Experimental group

Description:

Local anaesthesia (Lidocaïne) and Hypnosis

Treatment:

Procedure: Conventional procedure + Hypnosis