Hypnosis for Transesophageal Echocardiography

Utility of Hypnosis for Transesophageal Echocardiography

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01095705

Acronym

I-SLEPT

Enrollment

101

Registered

2010-03-30

Start date

2010-05-31

Completion date

2011-02-28

Last updated

2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discomfort

Keywords

Hypnosis, Transesophageal Echocardiography, Efficiency of Hypnosis

Brief summary

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

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.

Interventions

PROCEDUREConventional procedure

Local anaesthesia (Lidocaïne)

PROCEDUREConventional procedure + Hypnosis

Local anaesthesia (Lidocaïne) + Hypnosis (20 minutes)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Level of patient comfort	at Day 0	Visual Analogic Scale

Secondary

Measure	Time frame
Duration of the procedure	at Day 0
Quality of the procedure as assessed by the operator	at Day 0
Rate of procedure failure or non-diagnostic study	at Day 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026