Clinical Hypnosis Before External Cephalic Version (ECV)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014