Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT05766202
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2023-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The MOTIVE (Multiparas Overcoming Childbirth Fear Through Intervention and Empowerement) Feasibility Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2023-03-01', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Fear of Childbirth from baseline to pregnancy week 36 to 8 weeks after birth', 'timeFrame': 'Baseline, week 36 of pregnancy and 8 weeks after birth', 'description': 'The FOBS (Fear of Birth scale) is a validated, self-reported instrument assessing fear of childbirth. Possible scores range from 0 (no fear) to 100 (worst possible fear). Change= (week 36 score - baseline score and 8 weeks after birth - baseline).'}], 'secondaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'Baseline, week 36 of pregnancy and 8 weeks after birth', 'description': 'EPDS (Edinburgh postnatal depression scale) is a validated, self-reported instrument assessing depression.Change= (week 36 score - baseline score and 8 weeks after birth - baseline). Possible scores range from 0 to 30 points. A higher score pointing towards a worse outcome.'}, {'measure': 'Anxiety', 'timeFrame': 'Baseline, week 36 of pregnancy and 8 weeks after birth', 'description': 'HADS-A (Hospital Anxiety and depression scale - anxiety) is a validated, self-reported instrument assessing anxiety. Change= (week 36 score - baseline score and 8 weeks after birth - baseline).Possible scores range from 0 to 21 points. A higher score pointing towards a worse outcome.'}, {'measure': 'Childbirth experience', 'timeFrame': 'Only one measurement point, at 8-weeks after birth.', 'description': 'CPS (Childbirth perception scale) is a validated, self-reported instrument assessing childbirth experience. Possible scores range from 0 to 48 points. A higher score pointing towards a worse outcome.'}, {'measure': 'Pregnancy related anxiety', 'timeFrame': 'Baseline and week 36 of pregnancy', 'description': 'PRAQ-R2 (Pregnancy Related Anxiety Questionnaire for multiparas) is a validated, self-reported instrument assessing pregnancy related anxiety. Possible scores range from 10 to 50 points. A lower score pointing towards a worse outcome.'}, {'measure': 'Maternal childbirth experience', 'timeFrame': 'Only one measurement point, at 8-weeks after birth.', 'description': 'VAS (the visual analogue scale) is a ten-point horizontal line with verbal anchors at the extremes of the scale, where higher scores mean better outcomes. The minimum value is 1, and maximum value is 10. VAS has been used to measure the childbirth experience or satisfaction with the childbirth experience in various studies. In addition, VAS has been successfully tested against more detailed measurement instruments, such as the childbirth experience questionnaire (CEQ) and the Wijma Delivery Expectations / Experience Questionnaire (WDEQ-B).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multipara', 'Psychoeducation', 'Prenatal class', 'Midwife', 'Psychiatric nurse'], 'conditions': ['Fear of Childbirth', 'Anxiety', 'Depression']}, 'referencesModule': {'references': [{'pmid': '40405826', 'type': 'DERIVED', 'citation': 'Sandstrom L, Kaunonen M, Huhtala H, Aho AL. Evaluating a Group-Based Intervention Addressing Fear of Childbirth in Multiparous Pregnant Women: A Mixed Methods Feasibility Study. J Adv Nurs. 2025 May 23. doi: 10.1111/jan.17073. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to develop and pilot an intervention for the treatment of fear of childbirth for multiparas and to evaluate the feasibility of the intervention in the treatment of fear of childbirth in multiparas.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years of age\n* understands finnish language\n* has self reported fear of childbirth\n* is a multipara\n* under 35 weeks pregnant\n* willingness to participate in the study\n\nExclusion Criteria:\n\n* openly psychotic\n* at risk of suicide\n* serious substance abuse problems'}, 'identificationModule': {'nctId': 'NCT05766202', 'acronym': 'MOTIVE', 'briefTitle': 'The MOTIVE (Multiparas Overcoming Childbirth Fear Through Intervention and Empowerement) Feasibility Trial', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University'}, 'officialTitle': 'The Development and Feasibility of Fear of Childbirth Intervention Aiming to Reduce Fear in Pregnant Multiparas: a Mixed Methods Study', 'orgStudyIdInfo': {'id': 'ETL-R22124H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pilot intervention for multiparas with fear of childbirth', 'description': 'A group intervention with four meetings and one telephone call.', 'interventionNames': ['Other: An group intervention for multiparas with fear of childbirth']}], 'interventions': [{'name': 'An group intervention for multiparas with fear of childbirth', 'type': 'OTHER', 'description': 'The intervention consists of 4 group meetings, three during pregnancy and once after giving birth. It also includes a phone call.', 'armGroupLabels': ['Pilot intervention for multiparas with fear of childbirth']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hämeenlinna', 'country': 'Finland', 'facility': 'Kanta-Hämeen Keskussairaala', 'geoPoint': {'lat': 60.99596, 'lon': 24.46434}}], 'overallOfficials': [{'name': 'Laura Sandström, MHSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}, {'name': 'Metropolia University of Applied Sciences', 'class': 'OTHER'}, {'name': 'Kanta-Häme Central Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Laura Sandström', 'investigatorAffiliation': 'Tampere University'}}}}