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Clinical Hypnosis Before External Cephalic Version (ECV)

Primary Purpose

Breech Presentation at Term

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Clinical hypnosis or neuro-linguistic programming
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breech Presentation at Term focused on measuring breech presentation at term, pregnancy, external cephalic version (ECV), clinical hypnosis, neuro-linguistic programming (NLP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • singleton
  • breech presentation
  • gestation age above 36 weeks + 6 days

Exclusion Criteria:

  • multiples
  • cannot understand German language

Sites / Locations

  • Department of obstetrics and gynaecology, Johann Wolfgang Goethe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clinical hypnosis

Neuro-linguistic programming

Arm Description

20 minutes tape recorded clinical hypnosis intervention

20 minutes tape recording of nouro-linguistic programming intervention

Outcomes

Primary Outcome Measures

Successful ECV
Rate of cephalic presentation three hours after external cephalic version.

Secondary Outcome Measures

Questionnaire

Full Information

First Posted
March 24, 2012
Last Updated
March 26, 2012
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01564004
Brief Title
Clinical Hypnosis Before External Cephalic Version (ECV)
Official Title
Clinical Hypnosis Versus Neuro-linguistic Programming Before External Cephalic Version (ECV) - a Prospective Off-centre Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation at Term
Keywords
breech presentation at term, pregnancy, external cephalic version (ECV), clinical hypnosis, neuro-linguistic programming (NLP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
716 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical hypnosis
Arm Type
Experimental
Arm Description
20 minutes tape recorded clinical hypnosis intervention
Arm Title
Neuro-linguistic programming
Arm Type
Active Comparator
Arm Description
20 minutes tape recording of nouro-linguistic programming intervention
Intervention Type
Other
Intervention Name(s)
Clinical hypnosis or neuro-linguistic programming
Intervention Description
20 minutes tape recording intervention
Primary Outcome Measure Information:
Title
Successful ECV
Description
Rate of cephalic presentation three hours after external cephalic version.
Time Frame
3 hours after ECV treatment
Secondary Outcome Measure Information:
Title
Questionnaire
Time Frame
before and 30 minutes after ECV

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: singleton breech presentation gestation age above 36 weeks + 6 days Exclusion Criteria: multiples cannot understand German language
Facility Information:
Facility Name
Department of obstetrics and gynaecology, Johann Wolfgang Goethe University
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
50690
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joscha Reinhard, Priv.-Doz. Dr. MBBS BSc(Hon)
Phone
+49-(0)-157 76400061
Email
Joscha.Reinhard@kgu.de

12. IPD Sharing Statement

Learn more about this trial

Clinical Hypnosis Before External Cephalic Version (ECV)

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