Clinical Hypnosis Before External Cephalic Version (ECV)

March 26, 2012 updated by: PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospital

Clinical Hypnosis Versus Neuro-linguistic Programming Before External Cephalic Version (ECV) - a Prospective Off-centre Randomised Controlled Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

716

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 50690
        • Recruiting
        • Department of obstetrics and gynaecology, Johann Wolfgang Goethe University
        • Contact:
          • Joscha Reinhard, Priv.-Doz. Dr. MBBS BSc(Hon)
          • Phone Number: +49-(0)-157 76400061
          • Email: Joscha.Reinhard@kgu.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • multiples
  • cannot understand German language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Questionnaire
Time Frame: before and 30 minutes after ECV
before and 30 minutes after ECV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

March 24, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

March 27, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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