Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT06095869
Status:
UNKNOWN
Last Update Posted:
2023-10-23
First Post:
2023-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Progressive Relaxation Exercises,Breastfeeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'change in breastfeeding status', 'timeFrame': 'in the first two weeks postpartum, in the 1st and 2nd months after birth', 'description': 'To evaluate the breastfeeding status of mothers, a form evaluating the breastfeeding status prepared by the World Health Organization in 1991 was used.'}, {'measure': 'satisfaction rating', 'timeFrame': 'postpartum 4th month', 'description': 'A satisfaction scale was applied to evaluate the satisfaction of mothers with the interventions applied.This form, prepared by the researcher within the scope of the literature; It consists of five questions that evaluate how effective the application is for mothers in the PGE and GFM groups, how satisfied they are with the application, and whether they would recommend it to other mothers.'}], 'primaryOutcomes': [{'measure': 'Change in breastfeeding self-efficacy score averages change in breastfeeding self-efficacy scores', 'timeFrame': 'in the first two weeks postpartum, in the 1st and 2nd months after birth', 'description': 'To determine the breastfeeding self-efficacy score averages, the breastfeeding self-efficacy scale average scores were compared, and the breastfeeding self-efficacy scale was applied to the mothers.The scale assessing breastfeeding self-efficacy is a 5-point Likert type (1 = Not at all sure, 2 = Very unsure, 3 = Sometimes sure, 4 = Sure, 5 = Very sure). All items of the scale have a positive meaning. The highest score that can be obtained from the scale is 70 and the lowest score is 14. The scale has no cut-off point. Increasing scores on the scale indicate high breastfeeding self-efficacy.'}], 'secondaryOutcomes': [{'measure': 'change in maternal attachment score averages', 'timeFrame': 'postpartum 1st month and 2nd months after birth', 'description': 'To determine the maternal attachment mean scores, the maternal attachment mean scores were compared and the maternal attachment scale was applied to the mothers.Each item ranges from "always" to "never" and is a 4-point Likert-type scale. It is calculated as always (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points and never (d) = 1 point, and each item contains direct expressions. The lowest score obtained from the scale varies between 26 and the highest score 104. The higher the score obtained from the scale, the higher the maternal attachment is considered to be.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Progressive Relaxation Exercises']}, 'descriptionModule': {'briefSummary': "OBJECTIVE: The research was conducted to examine the effects of progressive relaxation exercises on mothers' breastfeeding status, self-efficacy and maternal attachment level.", 'detailedDescription': "may 2022 and November 2022. The sample of the study consisted of 114 mothers who were breastfeeding in the postpartum period. In the study, 38 breastfeeding mothers were included in the PGE, GFM and control groups. Breastfeeding mothers in the PGE group were given a PGE application 3 days a week before going to bed and for 4 weeks, accompanied by a training CD prepared by the Turkish Psychological Association, under the supervision of the researcher. On the other hand, the breastfeeding mothers in the GFM group were listened to the relaxation background music included in the Progressive Relaxation Exercise CD 3 days a week before going to bed and for 4 weeks. Mothers in the control group received routine care practices applied in the clinic. The mothers in the control group did not receive any intervention and only measurement tools were applied. 'Personal Information Form', 'Breastfeeding Self-Efficacy Scale' and 'Maternal Attachment Scale', 'Visual Analog Scale', 'Breastfeeding Classification' were used to collect data. Standard Deviation, Mean, Frequency and Chi-square tests were used to evaluate the data. Analysis of variance was used for repetitive measurements for the evaluation of breastfeeding self-efficacy and maternal attachment level within the group, and one-way analysis of variance was used for the evaluation between groups."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:Mothers over the age of 18,\n\n* At least primary school graduate, able to read and understand Turkish,\n* Has a phone and internet\n* Has an only and healthy baby,\n* Does not have a condition that prevents him from doing PGE,\n* The baby was born between 2500-4000 g,\n* Those who live within the provincial borders of Uşak,\n* No hearing problem,\n* Mothers of babies who do not have sucking problems (cleft palate-lip, frenilium, galactosemia, prematurity),\n* Mothers who do not have any health problems affecting breastfeeding (mastitis, breast abscess, nipple crack, candida albicans, flat and sunken nipples, Wilson's disease in the mother, an active disease of the mother that prevents breastfeeding, and drug use),\n* Mothers without musculoskeletal disorders, The mothers who volunteered to participate in the study.\n\nExclusion Criteria:\n\n* Practicing relaxation exercises before\n* Mothers using chronic opioids, antidepressants and psychoactive drugs."}, 'identificationModule': {'nctId': 'NCT06095869', 'briefTitle': 'Progressive Relaxation Exercises,Breastfeeding', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Ege University Faculty of Health Sciences Midwifery Department', 'orgStudyIdInfo': {'id': 'EGE-C-GOK-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'progressive relaxation exercise group', 'description': 'intervention group with progressive relaxation exercise', 'interventionNames': ['Other: progressive relaxation exercise', 'Other: relaxation background music', 'Other: control group']}, {'type': 'EXPERIMENTAL', 'label': 'relaxation background music group', 'description': 'intervention group with relaxation background music', 'interventionNames': ['Other: progressive relaxation exercise', 'Other: relaxation background music', 'Other: control group']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'group receiving routine health protocol and no intervention', 'interventionNames': ['Other: progressive relaxation exercise', 'Other: relaxation background music', 'Other: control group']}], 'interventions': [{'name': 'progressive relaxation exercise', 'type': 'OTHER', 'description': 'Breastfeeding mothers in the progressive relaxation exercise group were applied gradual relaxation exercise before going to bed 3 days a week and for 4 weeks, under the supervision of the researcher, accompanied by a training CD prepared by the Turkish Psychologists Association.', 'armGroupLabels': ['control group', 'progressive relaxation exercise group', 'relaxation background music group']}, {'name': 'relaxation background music', 'type': 'OTHER', 'description': 'In the relaxation background music group, breastfeeding mothers were listened to relaxation background music on the Progressive Relaxation Exercise CD before going to bed 3 days a week and for 4 weeks.', 'armGroupLabels': ['control group', 'progressive relaxation exercise group', 'relaxation background music group']}, {'name': 'control group', 'type': 'OTHER', 'description': 'Mothers in this group received routine care practices in the clinic. No intervention was made to the mothers in the control group, only data collection tools were applied.', 'armGroupLabels': ['control group', 'progressive relaxation exercise group', 'relaxation background music group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'çiğdem gök', 'role': 'CONTACT', 'email': 'akinakinanadolu_u@hotmail.com', 'phone': '05446293395'}], 'facility': 'Ege University Faculty of Health Sciences Midwifery Department', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'çiğdem gök', 'role': 'CONTACT', 'email': 'akinakinanadolu_u@hotmail.com', 'phone': '05446293395'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'specialist midwife', 'investigatorFullName': 'çigdem gök', 'investigatorAffiliation': 'Ege University'}}}}