Clinical Hypnosis Before External Cephalic Version (ECV)

This study is currently recruiting participants.
Verified March 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by (Responsible Party):
PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01564004
First received: March 24, 2012
Last updated: March 26, 2012
Last verified: March 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Successful ECV [ Time Frame: 3 hours after ECV treatment ] [ Designated as safety issue: No ]
    Rate of cephalic presentation three hours after external cephalic version.


Secondary Outcome Measures:
  • Questionnaire [ Time Frame: before and 30 minutes after ECV ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospitals
  More Information

No publications provided

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
Study First Received: March 24, 2012
Last Updated: March 26, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on April 17, 2014