Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-17 @ 6:15 PM
Study NCT ID:
NCT06769958
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2024-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Reflexology on Pain, Comfort and Breastfeeding Self-Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-12-31', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'pre-test post-test (approximately eight months), reduce pain', 'description': 'min-max (0-10), an increased score is a bad result'}, {'measure': 'Postpartum Comfort Scale', 'timeFrame': 'pre-test post-test (approximately eight months), Increasing Postpartum Comfort', 'description': 'min-max (34-170), increased score is a good result'}, {'measure': 'Breastfeeding Self-Efficacy Scale', 'timeFrame': 'pre-test post-test (approximately eight months), Increasing breastfeeding self-efficacy', 'description': 'min-max (14-70), increased score is a good result'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reflexology']}, 'descriptionModule': {'briefSummary': 'This study was conducted to determine the effects of reflexology applied to mothers with headache due to spinal anesthesia after Cesarean delivery on pain, comfort and breastfeeding self-efficacy levels. The study, which was conducted with a single-blind, randomized controlled experimental design, was conducted between April 2024 and August 2024 at the Department of Obstetrics and Pediatrics, SBU Van Training and Research Hospital with mothers who had cesarean delivery under spinal anesthesia and had postpartum headache (Intervention group=30, Control group=30). Foot reflexology was applied to the mothers in the intervention group for a total of 30 minutes, 15 minutes on each foot. The control group was not subjected to any intervention other than routine nursing practices. Personal Information Form, Visual Analog Scale (VAS), Postpartum Comfort Scale (PPSC) and Breastfeeding Self-Efficacy Scale (BSSE) were used as data collection tools.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older,\n* performing SD under spinal anesthesia,\n* experiencing postpartum headaches,\n* Caesarean section performed at 37-42 weeks of gestation,\n* giving only one live birth,\n* open to written or oral communication,\n* at least a primary school graduate,\n* no complications during pregnancy,\n* mothers who agreed to participate in the study\n\nExclusion Criteria:\n\n* Performing a cesarean section at periods other than 37-42 weeks of gestation,\n* caesarean section under general anesthesia,\n* have health problems such as fractures, dislocations, phlebitis, arthritis, burns, wounds, eczema, fungus or inflammation in the foot tissue,\n* with disease of the cardiovascular system,\n* with chronic diseases such as hypertension or diabetes mellitus,\n* Postpartum controlled analgesia administered,\n* mothers with psychiatric diagnoses such as anxiety and depression'}, 'identificationModule': {'nctId': 'NCT06769958', 'briefTitle': 'The Effect of Reflexology on Pain, Comfort and Breastfeeding Self-Efficacy', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'The Effect of Reflexology on Pain, Comfort and Breastfeeding Self-Efficacy in Post-Cesarean Headache Due to Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'Reflexology'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reflexology', 'interventionNames': ['Behavioral: Reflexology']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Reflexology', 'type': 'BEHAVIORAL', 'description': 'Reflexology application', 'armGroupLabels': ['Reflexology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65000', 'city': 'Van', 'state': 'Tuşba', 'country': 'Turkey (Türkiye)', 'facility': 'Van Yüzüncü Yıl University', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'Veysel Can', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}