Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-29 @ 9:00 PM
Study NCT ID:
NCT05438056
Status:
UNKNOWN
Last Update Posted:
2022-07-01
First Post:
2022-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Mobile Application Developed for Home Care of Preterm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled interventional research'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-06-24', 'lastUpdatePostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'baby care knowledge and skills form', 'timeFrame': 'up to 14 months', 'description': 'Form that measuring baby care knowledge and skills. The unabridged name of the form is baby care knowledge and skills form. Since the form created by the researcher has not been finalized, the lowest and highest scores to be obtained from the form are not certain. A high score indicates a high level of knowledge and skill of the mother.'}], 'primaryOutcomes': [{'measure': 'parent self-efficacy scale', 'timeFrame': 'up to 10 months', 'description': "scale that measures mother's self-efficacy for baby care.The unabridged name of the scale is parent self-efficacy scale. The lowest score obtained from the scale is 18, the highest score is 90. low score indicates high self-efficacy"}, {'measure': 'parent self-efficacy scale', 'timeFrame': 'up to 14 months', 'description': "scale that measures mother's self-efficacy for baby care.The unabridged name of the scale is parent self-efficacy scale. The lowest score obtained from the scale is 18, the highest score is 90. low score indicates high self-efficacy."}], 'secondaryOutcomes': [{'measure': 'maternal attachment scale', 'timeFrame': 'up to 10 months', 'description': 'scale that measuring mother-infant attachment. The unabridged name of the scale is maternal attachment scale. The lowest score obtained from the scale is 26, the highest score is 104. A high score indicates high maternal attachment.'}, {'measure': 'maternal attachment scale', 'timeFrame': 'up to 14 months', 'description': 'scale that measuring mother-infant attachment. The unabridged name of the scale is maternal attachment scale. The lowest score obtained from the scale is 26, the highest score is 104. A high score indicates high maternal attachment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mothers, premature, mobile application, education, home care'], 'conditions': ['Mother', 'Premature', 'Education', 'Home Care', 'Mobile Application']}, 'descriptionModule': {'briefSummary': "mobile application will be developed to support the post-discharge home care of mothers of premature babies. With the developed mobile application, the effect of the education given to the mothers on the knowledge and skills of infant care, mother-infant attachment, and the mother's self-efficacy will be evaluated.", 'detailedDescription': 'This research aims to examine the effect of the mobile application developed for the home care of the babies of the mothers of premature babies on their baby care knowledge and skills, mother-infant attachment and mother self-efficacy. A mobile application will be developed to support mothers who care for their premature babies at home after discharge. The application will be installed on the phones of mothers whose babies are discharged from the neonatal intensive care unit. After the babies are discharged, mothers will be trained at home with a mobile application. Maternal self-efficacy and mother-infant supplementation will be measured when infants admitted the NICU and one month after discharge the NICU.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor mothers;\n\n* Being over the age of 18,\n* Having a premature baby\n* At least primary school graduate,\n* Smart mobile app can be installed have a phone,\n* Being able to understand and speak Turkish,\n* Residing in Ankara\n\nFor babies;\n\n* 32-37 weeks of gestation of the baby (middle and borderline premature)\n* Baby in neonatal intensive care unit to stay\n* Not having undergone a surgical operation,\n* Absence of physical anomalies\n\nExclusion Criteria:\n\nFor Mothers;\n\n* Diagnosed with postpartum depression\n* unwillingness to participate in the study\n\nFor babies;\n\n\\- Very small preterm (born below 28 weeks of gestation) and small preterm (between 28 and 31 weeks of gestation)'}, 'identificationModule': {'nctId': 'NCT05438056', 'briefTitle': 'The Effect of the Mobile Application Developed for Home Care of Preterm', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': "The Effect of the Mobile Application Developed for Home Care of the Premature Baby on the Mother's Baby Care Skills, Self-efficacy and Mother-infant Bonding", 'orgStudyIdInfo': {'id': 'AnkaraU06GKY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'providing training to mothers of premature babies with a mobile application', 'description': 'providing training with mobile application to mothers discharged home with their premature babies +standard education prior to discharge', 'interventionNames': ['Other: education with mobile application']}, {'type': 'NO_INTERVENTION', 'label': 'standard education prior to discharge control group; standard education prior to discharge', 'description': 'standard education prior to discharge'}], 'interventions': [{'name': 'education with mobile application', 'type': 'OTHER', 'description': 'providing training to mothers of premature babies with a mobile application', 'armGroupLabels': ['providing training to mothers of premature babies with a mobile application']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'When the study is completed and published, the score obtained from the parent self-efficacy scale and maternal attachment scale will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gülçin KORKMAZ YENİCE', 'investigatorAffiliation': 'Ankara University'}}}}