Clinical Hypnosis Before External Cephalic Version (ECV) | NCT01564004

Studies
Clinical Hypnosis Before External Cephalic Version (ECV)

NCT01564004

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Unknown status

Last Update Posted

Mar 27, 2012Estimated

Enrollment

716Estimated

Phase

Not Applicable

Conditions

Breech Presentation at Term

Interventions

Clinical hypnosis or neuro-linguistic programming

Countries

Germany

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

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Feb 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

Mar 24, 2012

First Submission Date that Met QC Criteria

Mar 26, 2012

First Posted Date

Mar 27, 2012Estimated

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

Mar 26, 2012

Last Update Posted Date

Mar 27, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Principle Investigator, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

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

Does clinical hypnosis or neuro-linguistic programming improve the success rate of external cephalic version?

Detailed Description

Prospective off-center randomisation of clinical hypnosis or neuro-linguistic programming intervention prior to a external cephalic version treatment.

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

716Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clinical hypnosis	Experimental	20 minutes tape recorded clinical hypnosis intervention	Other: Clinical hypnosis or neuro-linguistic programming
Neuro-linguistic programming	Active Comparator	20 minutes tape recording of nouro-linguistic programming intervention	Other: Clinical hypnosis or neuro-linguistic programming

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clinical hypnosis or neuro-linguistic programming	Other	20 minutes tape recording intervention	Clinical hypnosis Neuro-linguistic programming

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful ECV	Rate of cephalic presentation three hours after external cephalic version.	3 hours after ECV treatment

Secondary Outcomes

Measure	Description	Time Frame
Questionnaire		before and 30 minutes after ECV

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

singleton
breech presentation
gestation age above 36 weeks + 6 days

Exclusion Criteria:

multiples
cannot understand German language

Accepts Healthy Volunteers

Sex

Female

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of obstetrics and gynaecology, Johann Wolfgang Goethe University	Recruiting	Frankfurt am Main	Hesse	50690	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D006990	Hypnosis
D020557	Neurolinguistic Programming

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided