Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-07 @ 6:12 AM
Study NCT ID:
NCT04109651
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2019-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Nursing Interventions on Maternal Attachment, Parental Self-efficacy and Infant Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-08-12', 'releaseDate': '2022-03-30'}, {'resetDate': '2023-07-10', 'releaseDate': '2022-08-16'}, {'resetDate': '2024-05-02', 'releaseDate': '2023-11-13'}, {'resetDate': '2024-09-13', 'releaseDate': '2024-05-03'}, {'resetDate': '2024-10-11', 'releaseDate': '2024-09-24'}, {'resetDate': '2025-02-27', 'releaseDate': '2025-02-07'}], 'estimatedResultsFirstSubmitDate': '2022-03-30'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The last data were collected nurses from primary health center (not researher) who did not know anything about participants of experiment and control group.\n\nData recorded on the computer by the assistant investigator without specifying the experiment and control group.\n\nThe experimental and control groups codified by the co-investigator. The analysis of the data encoded by the groups was done by a statistical expert. Data collectors, statistical analyzes and report writing were blinded.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional (Clinical Trial)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-26', 'studyFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2019-09-26', 'lastUpdatePostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'infant development level', 'timeFrame': 'At the end of 7 month', 'description': 'infant development at a high level'}], 'secondaryOutcomes': [{'measure': 'Maternal attachment scores', 'timeFrame': 'At the end of 7 month', 'description': 'Mother will increase infant attachment level'}, {'measure': 'Parental self-efficacy scales scores', 'timeFrame': 'At the end of 7 month', 'description': 'Mother self-efficacy level will increase'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Nurse's Role", 'Parenting', 'Self Efficacy', 'Development, Child', 'Attachment']}, 'descriptionModule': {'briefSummary': "The aim of this study was to determine the effects of Meleis 'Transition Theory based health improvement monitoring program on infants' development, maternal attachment and parental self-efficacy in 36-40 weeks of gestation and in the first and fourth months after birth. Sample was 64 (experimental group:32; control group: 32), alfa=0,05 and power=0.80 at the end of study. The experimental group received nursing interventions based on Meleis' Transition Theory, while the control group received routine primary health care. Data were collected 3 times: pretest, 3 and 7 months after intervention (for experimental group) and 3 and 7 months after pretest (for control group).", 'detailedDescription': "Motherhood is one of the most important milestones in a woman's life, and at the same time the beginning of a process in which very important responsibilities are undertaken. The mother needs knowledge, skills and energy to fulfill her new responsibilities. The development of motherhood identity is the process of learning motherhood behaviors of women. This process starts with the recognition of pregnancy, develops during pregnancy and continues after birth. Transition Theory is a suitable tool for nurses to understand the transition to parenting, a developmental type of transition. Appropriate nursing interventions tailored to the needs of pregnant women and women who have just given birth are needed. Targeted / predicted change in the large / large effect size of the mothers in the experimental group (effect size 0.80, 80% of the standard deviation) with the Health Promotion Monitoring Program, the sample calculation with 5% alpha error and 80% power was the minimum for each group. It was determined that a total of 52 people (26 \\*) should be recruited (G \\* Power 3.1.9.2). It was decided to include at least 32 people in each working group with a 20% surplus, considering that they might be lost in data collection. Women's experiences in transition to motherhood should be sought to propose, define, and explain professional interventions. In this study, a Health Promotion Program starting from 36-40 weeks of gestation until the sixth month of birth was administered to the mothers registered at the primary health care center in Karatay, Konya. In this study, the investigator planned to increase maternal infant attachment, to increase parental self-efficacy, to keep infant development at the best level, thus ensuring a healthy transition for the mother.\n\nDuration of intervention and collecting data for the study was 11 months. Data was collected using information form (21 item; information about participant, parents and infant), three scales (Turkish Version of Maternal Attachment Inventory; parental self-efficacy scale, Denver II development screening test). Scales validation and reliability studies were made for Turkish population."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having at least primary school graduation\n* 18 Years and older\n* Lack of any chronic disease\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Risk of preterm birth\n* Does not speak Turkish\n* Pregnant / mothers not attending at least one education and / or measurement\n* Want to leave the work\n* Presence of mental or physical illnesses such as postpartum depression during follow-up\n* Baby; Presence of congenital and / or metabolic disease during prenatal and postnatal postnatal follow-up'}, 'identificationModule': {'nctId': 'NCT04109651', 'briefTitle': 'The Effect of Nursing Interventions on Maternal Attachment, Parental Self-efficacy and Infant Development', 'organization': {'class': 'OTHER', 'fullName': 'KTO Karatay University'}, 'officialTitle': 'Influence of Nursing Intervention on Mother and Infant, Materna Attachment, Parental Self-efficacy, Infant Development', 'orgStudyIdInfo': {'id': 'KaratayU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nursing İntervention', 'description': 'Intervention: Other: Nursing intervention', 'interventionNames': ['Other: Nursing intervention']}, {'type': 'OTHER', 'label': 'No Intervention: Control Group', 'description': 'Receive routine nursing care', 'interventionNames': ['Other: Nursing intervention']}], 'interventions': [{'name': 'Nursing intervention', 'type': 'OTHER', 'otherNames': ['No Intervention: Control Group'], 'description': "Nursing Intervention: This intervention was planned based on Meleis' Transition Theory. So it includes individual counseling and training.\n\nIn the Health Promotion Monitoring Program; three training modules and one reminder module were implemented and telephone counseling was provided. Various training tools were used in these trainings. Three different power point presentations were made during the training sessions. Illustrated printed training material was used. At the end of the training, training booklet was given to the participants.", 'armGroupLabels': ['No Intervention: Control Group', 'Nursing İntervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Kto Karatay University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'FATMA TAŞ ARSLAN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SELÇUK UNİVERSİTY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I do not plan to share any data of participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KTO Karatay University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching a-Assistant', 'investigatorFullName': 'Figen Türkdüdükçü', 'investigatorAffiliation': 'KTO Karatay University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-03-30', 'type': 'RELEASE'}, {'date': '2022-08-12', 'type': 'RESET'}, {'date': '2022-08-16', 'type': 'RELEASE'}, {'date': '2023-07-10', 'type': 'RESET'}, {'date': '2023-11-13', 'type': 'RELEASE'}, {'date': '2024-05-02', 'type': 'RESET'}, {'date': '2024-05-03', 'type': 'RELEASE'}, {'date': '2024-09-13', 'type': 'RESET'}, {'date': '2024-09-24', 'type': 'RELEASE'}, {'date': '2024-10-11', 'type': 'RESET'}, {'date': '2025-02-07', 'type': 'RELEASE'}, {'date': '2025-02-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Figen Turk Dudukcu, Teaching a-Assistant, KTO Karatay University'}}}}