NCT01564004

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
716

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 27, 2012

Status Verified

March 1, 2012

Enrollment Period

3 years

First QC Date

March 24, 2012

Last Update Submit

March 26, 2012

Conditions

Breech Presentation at Term

Keywords

breech presentation at termpregnancyexternal cephalic version (ECV)clinical hypnosisneuro-linguistic programming (NLP)

Outcome Measures

Primary Outcomes (1)

  • Successful ECV

    Rate of cephalic presentation three hours after external cephalic version.

    3 hours after ECV treatment

Secondary Outcomes (1)

  • Questionnaire

    before and 30 minutes after ECV

Study Arms (2)

Clinical hypnosis

EXPERIMENTAL

20 minutes tape recorded clinical hypnosis intervention

Other: Clinical hypnosis or neuro-linguistic programming

Neuro-linguistic programming

ACTIVE COMPARATOR

20 minutes tape recording of nouro-linguistic programming intervention

Other: Clinical hypnosis or neuro-linguistic programming

Interventions

Clinical hypnosis or neuro-linguistic programmingOTHER

20 minutes tape recording intervention

Clinical hypnosisNeuro-linguistic programming

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • multiples
  • cannot understand German language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of obstetrics and gynaecology, Johann Wolfgang Goethe University

Frankfurt am Main, Hesse, 50690, Germany

RECRUITING

MeSH Terms

Interventions

HypnosisNeurolinguistic Programming

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesModels, NeurologicalModels, BiologicalModels, TheoreticalInvestigative TechniquesModels, PsychologicalPsycholinguisticsBehavioral Sciences

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 24, 2012

First Posted

March 27, 2012

Study Start

February 1, 2011

Primary Completion

February 1, 2014

Study Completion

September 1, 2014

Last Updated

March 27, 2012

Record last verified: 2012-03

Locations

DE(1)