Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT02899494
Status:
COMPLETED
Last Update Posted:
2019-08-15
First Post:
2016-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the "Adjusted Vocal Expression" Method on the Satisfaction of Parturients About Their Childbirth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064186', 'term': 'Prenatal Education'}, {'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D010353', 'term': 'Patient Education as Topic'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Childbirth Perception Questionnaire (CPQ) score', 'timeFrame': '5 months', 'description': 'French adaptation of CPQ score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'To emit voluntarily sounds mastered during the childbirth is a practice found in certain cultures of country of Africa or Muslim or gypsy traditions. Today, because of the medical coverage and because of the childbirth in a hospital environment, this tradition is not anymore transmitted.\n\nThe emission of a sound vibration conjugated to a positive intention managed during the childbirth was experimented with around thirty mothers. In the term of this pilot study, most of the women expressed one felt very positive towards the new method, in particular when they compared it with a previous childbirth where this method was not used.\n\nDuring these childbirths, the midwives also indicated a shortening of the working time.\n\nThe present study aim essentially is to confirm the positive effect of the method on the felt of the childbirth.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women of more than 18 years old\n* Primipara\n* Patients joining the antenatal classes dispensed by the midwives.\n* Patients affiliated to a national insurance scheme or benefiting from such a diet\n* Patients having given a written consent form\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02899494', 'acronym': 'NaitreEnchan', 'briefTitle': 'Effect of the "Adjusted Vocal Expression" Method on the Satisfaction of Parturients About Their Childbirth', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Effect of the "Adjusted Vocal Expression" Method on the Satisfaction of Parturients About Their Childbirth (NaîtreEnchanté)', 'orgStudyIdInfo': {'id': '2012/10'}, 'secondaryIdInfos': [{'id': '2012-A00716-37', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A', 'description': 'Antenatal classes', 'interventionNames': ['Other: Antenatal classes']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Physical and psychic preparation', 'interventionNames': ['Other: Physical and psychic preparation']}], 'interventions': [{'name': 'Antenatal classes', 'type': 'OTHER', 'armGroupLabels': ['Group A']}, {'name': 'Physical and psychic preparation', 'type': 'OTHER', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84123', 'city': 'Pertuis', 'country': 'France', 'facility': 'Maternité Catherine BARET de Pertuis', 'geoPoint': {'lat': 43.69415, 'lon': 5.50291}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Jean-Marc AYOUBI, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Foch'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}