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Completed

NCT Number: NCT01095705

Hypnosis for Transesophageal Echocardiography

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional procedure

Procedure

Local anaesthesia (Lidocaïne)

Conventional procedure + Hypnosis

Procedure

Local anaesthesia (Lidocaïne) + Hypnosis (20 minutes)

Primary outcomes

  1. Level of patient comfort

    Time frame: at Day 0

    Visual Analogic Scale

Secondary outcomes

  1. Rate of procedure failure or non-diagnostic study

    Time frame: at Day 0

  2. Duration of the procedure

    Time frame: at Day 0

  3. Quality of the procedure as assessed by the operator

    Time frame: at Day 0

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Utility of Hypnosis for Transesophageal Echocardiography

Acronym: I-SLEPT

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Mar 30, 2010
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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