NCT01095705

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

December 19, 2013

Status Verified

March 1, 2010

Enrollment Period

6 months

First QC Date

March 29, 2010

Last Update Submit

December 18, 2013

Conditions

Discomfort

Keywords

HypnosisTransesophageal EchocardiographyEfficiency of Hypnosis

Outcome Measures

Primary Outcomes (1)

  • Level of patient comfort

    Visual Analogic Scale

    at Day 0

Secondary Outcomes (3)

  • Rate of procedure failure or non-diagnostic study

    at Day 0

  • Duration of the procedure

    at Day 0

  • Quality of the procedure as assessed by the operator

    at Day 0

Study Arms (2)

Conventional procedure

ACTIVE COMPARATOR

Local anaesthesia (Lidocaïne)

Procedure: Conventional procedure

Conventional procedure + Hypnosis

EXPERIMENTAL

Local anaesthesia (Lidocaïne) and Hypnosis

Procedure: Conventional procedure + Hypnosis

Interventions

Conventional procedurePROCEDURE

Local anaesthesia (Lidocaïne)

Conventional procedure
Conventional procedure + HypnosisPROCEDURE

Local anaesthesia (Lidocaïne) + Hypnosis (20 minutes)

Conventional procedure + Hypnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with indication for a Transesophageal Echo (TEE)
  • Patient competent to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler

Paris, 75010, France

Location

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • François TOURNOUX, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2010

First Posted

March 30, 2010

Study Start

May 1, 2010

Primary Completion

November 1, 2010

Study Completion

February 1, 2011

Last Updated

December 19, 2013

Record last verified: 2010-03

Locations

FR(1)