Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT04741867
Status:
UNKNOWN
Last Update Posted:
2021-02-05
First Post:
2021-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Education Based on Roy Adaptation Model for Infertile Individuals on Adaptation and Coping With Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 61}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Training effectiveness', 'timeFrame': '3 months', 'description': 'The education given will increase adaptation to infertility and coping with existing stress.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Education']}, 'descriptionModule': {'briefSummary': 'Psychosocial counseling applied together with infertility treatment programs makes infertile women more resistant to stress, increases the effectiveness of infertility treatments and encourages infertile patients to continue treatment by improving their mental health.\n\nIt appears that learning adaptation strategies in infertile couples is concurrent with health promotion. In addition to medical treatments, it is aimed to add training to be given in accordance with the Roy Adaptation model, to adapt to the process and infertility, and to control stress in infertile individuals in the management of the process.\n\nThe study was planned to examine the effect of education based on the roy adaptation model for infertile individuals on adaptation and coping with stress.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'infertile woman', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45age difference\n\nPrimary infertility\n\nExclusion Criteria:\n\n\\- Secondery infertility'}, 'identificationModule': {'nctId': 'NCT04741867', 'briefTitle': 'The Effect of Education Based on Roy Adaptation Model for Infertile Individuals on Adaptation and Coping With Stress', 'organization': {'class': 'OTHER', 'fullName': 'Gaziantep Islam Science and Technology University'}, 'officialTitle': 'Hasan Kalyoncu University Health Sciences Institute', 'orgStudyIdInfo': {'id': 'Hasan Kalyoncu Unıversity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'receiving health education', 'interventionNames': ['Other: Education']}, {'type': 'EXPERIMENTAL', 'label': 'Level of compliance', 'interventionNames': ['Other: Education']}, {'type': 'EXPERIMENTAL', 'label': 'Coping with stress', 'interventionNames': ['Other: Education']}], 'interventions': [{'name': 'Education', 'type': 'OTHER', 'description': 'Patients will be educated to determine their level of coping with stress and their adaptation.', 'armGroupLabels': ['Coping with stress', 'Level of compliance', 'receiving health education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Hasan Kalyoncu Üniversitesi', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}], 'centralContacts': [{'name': 'Ayşe Duygu Özbaş', 'role': 'CONTACT', 'email': 'duyguyildirim75@gmail.com', 'phone': '905337625707'}], 'overallOfficials': [{'name': 'Ayşe Duygu Özbaş', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasan Kalyoncu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziantep Islam Science and Technology University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor', 'investigatorFullName': 'Ayşe Duygu Özbaş', 'investigatorAffiliation': 'Gaziantep Islam Science and Technology University'}}}}