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Clinical Hypnosis Before External Cephalic Version (ECV)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospitals.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01564004
First Posted: March 27, 2012
Last Update Posted: March 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospitals
  Purpose
Does clinical hypnosis or neuro-linguistic programming improve the success rate of external cephalic version?

Condition Intervention
Breech Presentation at Term Other: Clinical hypnosis or neuro-linguistic programming

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Hypnosis Versus Neuro-linguistic Programming Before External Cephalic Version (ECV) - a Prospective Off-centre Randomised Controlled Trial

Further study details as provided by PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Successful ECV [ Time Frame: 3 hours after ECV treatment ]
    Rate of cephalic presentation three hours after external cephalic version.


Secondary Outcome Measures:
  • Questionnaire [ Time Frame: before and 30 minutes after ECV ]

Estimated Enrollment: 716
Study Start Date: February 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clinical hypnosis
20 minutes tape recorded clinical hypnosis intervention
Other: Clinical hypnosis or neuro-linguistic programming
20 minutes tape recording intervention
Active Comparator: Neuro-linguistic programming
20 minutes tape recording of nouro-linguistic programming intervention
Other: Clinical hypnosis or neuro-linguistic programming
20 minutes tape recording intervention

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • multiples
  • cannot understand German language
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564004


Locations
Germany
Department of obstetrics and gynaecology, Johann Wolfgang Goethe University Recruiting
Frankfurt, Hessen, Germany, 50690
Contact: Joscha Reinhard, Priv.-Doz. Dr. MBBS BSc(Hon)    +49-(0)-157 76400061    Joscha.Reinhard@kgu.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
  More Information

Responsible Party: PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Principle Investigator, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01564004     History of Changes
Other Study ID Numbers: 12/11
First Submitted: March 24, 2012
First Posted: March 27, 2012
Last Update Posted: March 27, 2012
Last Verified: March 2012

Keywords provided by PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospitals:
breech presentation at term
pregnancy
external cephalic version (ECV)
clinical hypnosis
neuro-linguistic programming (NLP)

Additional relevant MeSH terms:
Breech Presentation
Obstetric Labor Complications
Pregnancy Complications