Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-28 @ 11:01 PM
Study NCT ID:
NCT01564004
Status:
UNKNOWN
Last Update Posted:
2012-03-27
First Post:
2012-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Hypnosis Before External Cephalic Version (ECV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'D020557', 'term': 'Neurolinguistic Programming'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D008959', 'term': 'Models, Neurological'}, {'id': 'D008954', 'term': 'Models, Biological'}, {'id': 'D008962', 'term': 'Models, Theoretical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008960', 'term': 'Models, Psychological'}, {'id': 'D011578', 'term': 'Psycholinguistics'}, {'id': 'D001525', 'term': 'Behavioral Sciences'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 716}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-26', 'studyFirstSubmitDate': '2012-03-24', 'studyFirstSubmitQcDate': '2012-03-26', 'lastUpdatePostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful ECV', 'timeFrame': '3 hours after ECV treatment', 'description': 'Rate of cephalic presentation three hours after external cephalic version.'}], 'secondaryOutcomes': [{'measure': 'Questionnaire', 'timeFrame': 'before and 30 minutes after ECV'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breech presentation at term', 'pregnancy', 'external cephalic version (ECV)', 'clinical hypnosis', 'neuro-linguistic programming (NLP)'], 'conditions': ['Breech Presentation at Term']}, 'descriptionModule': {'briefSummary': 'Does clinical hypnosis or neuro-linguistic programming improve the success rate of external cephalic version?', 'detailedDescription': 'Prospective off-center randomisation of clinical hypnosis or neuro-linguistic programming intervention prior to a external cephalic version treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton\n* breech presentation\n* gestation age above 36 weeks + 6 days\n\nExclusion Criteria:\n\n* multiples\n* cannot understand German language'}, 'identificationModule': {'nctId': 'NCT01564004', 'briefTitle': 'Clinical Hypnosis Before External Cephalic Version (ECV)', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Clinical Hypnosis Versus Neuro-linguistic Programming Before External Cephalic Version (ECV) - a Prospective Off-centre Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '12/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical hypnosis', 'description': '20 minutes tape recorded clinical hypnosis intervention', 'interventionNames': ['Other: Clinical hypnosis or neuro-linguistic programming']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neuro-linguistic programming', 'description': '20 minutes tape recording of nouro-linguistic programming intervention', 'interventionNames': ['Other: Clinical hypnosis or neuro-linguistic programming']}], 'interventions': [{'name': 'Clinical hypnosis or neuro-linguistic programming', 'type': 'OTHER', 'description': '20 minutes tape recording intervention', 'armGroupLabels': ['Clinical hypnosis', 'Neuro-linguistic programming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50690', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joscha Reinhard, Priv.-Doz. Dr. MBBS BSc(Hon)', 'role': 'CONTACT', 'email': 'Joscha.Reinhard@kgu.de', 'phone': '+49-(0)-157 76400061'}], 'facility': 'Department of obstetrics and gynaecology, Johann Wolfgang Goethe University', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'PD Dr. med. Joscha Reinhard, MBBS BSc(Hon)', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}