Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT01566058
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2012-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and Mother-child Relationships
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-29', 'studyFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2012-03-28', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire HADS', 'timeFrame': 'Day 3 post-partum', 'description': 'Score ranging from 0 - 21'}], 'secondaryOutcomes': [{'measure': 'Questionnaire HADS', 'timeFrame': 'baseline; day 0', 'description': 'score ranging from 0 to 21'}, {'measure': 'Questionnaire HADS', 'timeFrame': 'Day 1 post partum', 'description': 'score ranging from 0 to 21'}, {'measure': 'Questionnaire HADS', 'timeFrame': 'Day 7 post partum', 'description': 'score ranging from 0 to 21'}, {'measure': 'Questionnaire HADS', 'timeFrame': 'Day of hospital discharge for the baby (expected average of 4 weeks)', 'description': 'score ranging from 0 to 21'}, {'measure': 'Questionnaire PPQ (post traumatic stress disorder)', 'timeFrame': '6 months post partum', 'description': 'score ranging from 0 to 14'}, {'measure': 'Questionnaire PPQ (post traumatic stress disorder)', 'timeFrame': '12 months post partum', 'description': 'score ranging from 0 to 14'}, {'measure': 'Massie Campbell scale for mother-child relationships', 'timeFrame': 'Day of hospital discharge for the baby (expected average of 4 weeks)'}, {'measure': 'Massie Campbell scale for mother-child relationships', 'timeFrame': '6 months post partum'}, {'measure': 'Massie Campbell scale for mother-child relationships', 'timeFrame': '12 months post partum'}, {'measure': 'Number of infant cardiovascular events', 'timeFrame': 'base line to day of hospital discharge for the baby (expected average of 4 weeks)', 'description': 'includes bradycardia \\< 100/min and O2 saturation \\< 60%'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post partum', 'mother-child relationships'], 'conditions': ['Stress Disorders, Post-Traumatic', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the degree of maternal anxiety at Day 3 postpartum in mothers who did or did not have access to a video communication system (BB-Box system) from the time of initial separation with their baby.', 'detailedDescription': 'The secondary objectives of the study are to compare the following between the two arms of the study:\n\nA. The degree of postpartum maternal anxiety at day 1, day 7 and at hospital discharge. Anxiety will be compared point by point but also via kinetics.\n\nB. The incidence maternal post traumatic stress disorder at 6 and 12 months.\n\nC. The incidence of mother-child relationship disorders at 6 and 12 months.\n\nD. Infant vital signs during the hospital stay.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is available for 12 months of follow up\n* The patient has given birth this day to a premature child (\\< 36 weeks of gestation and/or \\< 2 kg birthweight)\n* Separation of child and mother since birth\n\nExclusion Criteria:\n\n* The patient or baby is participating in another study, excepting the studies "OASIS" or "PROM8736"\n* The patient or baby is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient or father refuses to sign the consent\n* It is impossible to correctly inform the patient\n* Preexisting maternal psychiatric pathology\n* Major or lethal poly-malformation syndrome\n* Severe pathologies that threaten child survival: pulmonary hypertension, septic shock, anoxic-ischemic brain\n* Any emergency situation preventing patient involvement\n* Mother and/or child not hospitalized at the Nîmes University Hospital\n* Death of the patient or child during the study'}, 'identificationModule': {'nctId': 'NCT01566058', 'acronym': 'BBBox', 'briefTitle': 'Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and Mother-child Relationships', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Pilot Study Evaluating the Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and the Establishment of a Mother-child Relationship in the Context of a Premature Birth', 'orgStudyIdInfo': {'id': 'LOCAL/2011/FBC-01'}, 'secondaryIdInfos': [{'id': '2012-A00327-36', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With BB Box', 'description': 'The mothers in this arm of the study will have access to a "BB Box" video system to maintain contact with their premature baby.', 'interventionNames': ['Device: BB Box available']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Without BB Box', 'description': 'The mothers in this arm of the study will not have access to a "BB Box" video system to maintain contact with their premature baby. (Standard care)', 'interventionNames': ['Other: No BB Box']}], 'interventions': [{'name': 'BB Box available', 'type': 'DEVICE', 'description': 'The BB Box video system is provided to the mother during the hospitalisation of her premature baby.', 'armGroupLabels': ['With BB Box']}, {'name': 'No BB Box', 'type': 'OTHER', 'otherNames': ['Standard care'], 'description': 'The BB Box video system is not provided to the mother during the hospitalisation of her premature baby.', 'armGroupLabels': ['Without BB Box']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Fernando Benito-Castro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}