Hypnosis for Transesophageal Echocardiography | NCT01095705

Studies
Hypnosis for Transesophageal Echocardiography

NCT01095705

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Dec 19, 2013Estimated

Enrollment

101Actual

Phase

Not Applicable

Conditions

Discomfort

Interventions

Conventional procedure
Conventional procedure + Hypnosis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-A01156-51	Other Identifier	IDRCB

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Feb 2011Actual

First Submitted Date

Mar 29, 2010

First Submission Date that Met QC Criteria

Mar 29, 2010

First Posted Date

Mar 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2013

Last Update Posted Date

Dec 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional procedure	Active Comparator	Local anaesthesia (Lidocaïne)	Procedure: Conventional procedure
Conventional procedure + Hypnosis	Experimental	Local anaesthesia (Lidocaïne) and Hypnosis	Procedure: Conventional procedure + Hypnosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conventional procedure	Procedure	Local anaesthesia (Lidocaïne)	Conventional procedure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François TOURNOUX, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler		Paris		75010	France

Intervention Browse Module

MeSH Terms

ID	Term
D006990	Hypnosis

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D011613	Psychotherapy

Browse Leaves

Not provided

Browse Branches

Not provided