Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT01758133
Status:
UNKNOWN
Last Update Posted:
2013-01-01
First Post:
2012-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Medical Clown Activity on Milk Production of Mothers of Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-24', 'studyFirstSubmitDate': '2012-12-24', 'studyFirstSubmitQcDate': '2012-12-24', 'lastUpdatePostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of breast milk produced', 'timeFrame': 'One week', 'description': 'Mothers who have either been exposed or not exposed to medical clown activities will pump their breast milk. The milk will be measured and the two groups production will be compared.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Milk']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether medical clown activity enables relaxation of mothers of premature infants, and as a result increases their breast milk production.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Mothers of premature infants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nursing mothers of infants born less than 34th week\n\nExclusion Criteria:\n\n* Sick mothers\n* Take medication forbidden during nursing'}, 'identificationModule': {'nctId': 'NCT01758133', 'briefTitle': 'Influence of Medical Clown Activity on Milk Production of Mothers of Premature Infants', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': '006612-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mothers exposed to medical clowns', 'description': 'Mothers of premature infants who have been exposed to medical clown activities', 'interventionNames': ['Behavioral: Exposure to medical clown activities']}, {'label': 'Mothers not exposed to medical clown activity'}], 'interventions': [{'name': 'Exposure to medical clown activities', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Mothers exposed to medical clowns']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Ramit Magen-Rimon, MD', 'role': 'CONTACT', 'email': 'ramit.magen@gmail.com', 'phone': '972-54-3064660'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}