Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT06628960
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Su Jok Therapy on Breastfeeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-10-03', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breastfeeding Self-Efficacy Scale', 'timeFrame': 'pre-test', 'description': 'It was developed by Dennis (2003). Its Turkish validity and reliability was conducted by Aluş Tokat et al. (2010). The scale consists of 14 items and is in five-point Likert type. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.'}, {'measure': 'Breastfeeding Self-Efficacy Scale', 'timeFrame': '3rd day after caesarean section', 'description': 'It was developed by Dennis (2003). Its Turkish validity and reliability was conducted by Aluş Tokat et al. (2010). The scale consists of 14 items and is in five-point Likert type. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.'}, {'measure': 'Breastfeeding Self-Efficacy Scale', 'timeFrame': '10th day after caesarean section', 'description': 'It was developed by Dennis (2003). Its Turkish validity and reliability was conducted by Aluş Tokat et al. (2010). The scale consists of 14 items and is in five-point Likert type. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.'}, {'measure': 'Breastfeeding Charting System: LATCH', 'timeFrame': 'pre-test', 'description': 'It was developed by Jensen et al. (1994). Its Turkish validity and reliability was performed by Yenal and Okumuş (2003). LATCH includes five evaluation criteria and consists of the first letters of the English equivalents of these criteria. In the LATCH Scoring System, 0, 1 or 2 points are given for each criterion A minimum score of 0 and a maximum score of 10 can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.'}, {'measure': 'Breastfeeding Charting System: LATCH', 'timeFrame': '3rd day after caesarean section', 'description': 'It was developed by Jensen et al. (1994). Its Turkish validity and reliability was performed by Yenal and Okumuş (2003). LATCH includes five evaluation criteria and consists of the first letters of the English equivalents of these criteria. In the LATCH Scoring System, 0, 1 or 2 points are given for each criterion. A minimum score of 0 and a maximum score of 10 can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.'}, {'measure': 'Breastfeeding Charting System: LATCH', 'timeFrame': '10th day after caesarean section', 'description': 'It was developed by Jensen et al. (1994). Its Turkish validity and reliability was performed by Yenal and Okumuş (2003). LATCH includes five evaluation criteria and consists of the first letters of the English equivalents of these criteria. In the LATCH Scoring System, 0, 1 or 2 points are given for each criterion. A minimum score of 0 and a maximum score of 10 can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.'}, {'measure': 'Inadequate Milk Perception Scale', 'timeFrame': 'pre-test', 'description': 'The scale developed by McCarter-Spaulding and Kearney in 2001 consists of 6 questions to determine inadequate perception of breast milk. The first question questioning whether the mother perceives her milk as sufficient or not is in the form of \'yes\' or \'no\'. The other 5 questions aim to measure the perception of inadequacy of milk and are scored between 0-10. \'0\' indicates that milk is perceived as completely inadequate and "10" indicates that milk is perceived as completely adequate. The scale is scored between 0-50. A high score indicates an increased perception of milk sufficiency.'}, {'measure': 'Inadequate Milk Perception Scale', 'timeFrame': '3rd day after caesarean section', 'description': 'The scale developed by McCarter-Spaulding and Kearney in 2001 consists of 6 questions to determine inadequate perception of breast milk. The first question questioning whether the mother perceives her milk as sufficient or not is in the form of \'yes\' or \'no\'. The other 5 questions aim to measure the perception of inadequacy of milk and are scored between 0-10. \'0\' indicates that milk is perceived as completely inadequate and "10" indicates that milk is perceived as completely adequate. The scale is scored between 0-50. A high score indicates an increased perception of milk sufficiency.'}, {'measure': 'Inadequate Milk Perception Scale', 'timeFrame': '10th day after caesarean section', 'description': 'The scale developed by McCarter-Spaulding and Kearney in 2001 consists of 6 questions to determine inadequate perception of breast milk. The first question questioning whether the mother perceives her milk as sufficient or not is in the form of \'yes\' or \'no\'. The other 5 questions aim to measure the perception of inadequacy of milk and are scored between 0-10. \'0\' indicates that milk is perceived as completely inadequate and "10" indicates that milk is perceived as completely adequate. The scale is scored between 0-50. A high score indicates an increased perception of milk sufficiency.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Su Jok therapy', 'cesarean section', 'breastfeeding'], 'conditions': ['Breastfeeding']}, 'descriptionModule': {'briefSummary': "There are many alternative methods to increase breast milk. In the literature, studies on Su Jok therapy applications are limited and no studies on increasing breast milk have been found. In Korean language, 'Su' means hand and 'Jok' means foot. Su Jok therapy is defined as a modern acupressure/acupuncture interpretation that utilises the body's independent communication systems on the hands and feet by applying various techniques such as massage, moxa (heating), needles, magnets and seeds to the reflection points on the hands and feet. Su Jok is an integrated therapy that incorporates many tried and trusted methods of oriental medicine", 'detailedDescription': "There are many alternative methods to increase breast milk. In the literature, studies on Su Jok therapy applications are limited and no studies on increasing breast milk have been found. In Korean language, 'Su' means hand and 'Jok' means foot. Su Jok therapy is defined as a modern acupressure/acupuncture interpretation that utilises the body's independent communication systems on the hands and feet by applying various techniques such as massage, moxa (heating), needles, magnets and seeds to the reflection points on the hands and feet. Su Jok is an integrated therapy that incorporates many tried and trusted methods of oriental medicine."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'primiparous women giving birth by caesarean section, women aged 19-35, breastfeeding women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primiparous women giving birth by caesarean section,\n* women aged 19-35,\n* breastfeeding women\n\nExclusion Criteria:\n\n* those who refused to participate in the research'}, 'identificationModule': {'nctId': 'NCT06628960', 'acronym': 'Sujok', 'briefTitle': 'Effect of Su Jok Therapy on Breastfeeding', 'organization': {'class': 'OTHER', 'fullName': 'University of Gaziantep'}, 'officialTitle': 'The Effect of Su Jok Therapy on Breastfeeding Success, Breastfeeding Self-Efficacy and Perception of Insufficient Milk After Caesarean Section in Primiparas', 'orgStudyIdInfo': {'id': 'MAUN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'su jok therapy;', 'description': 'su jok therapy; application of seeds placed at certain points on the palm of the hand every day for the first ten days after birth, every day to be kept in the hand for 2 hours.', 'interventionNames': ['Behavioral: Su Jok Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'control group, Su Jok will not be applied'}], 'interventions': [{'name': 'Su Jok Therapy', 'type': 'BEHAVIORAL', 'description': 'Su Jok Therapy', 'armGroupLabels': ['su jok therapy;']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Sanliurfa', 'state': 'Eyalet/Yerleşke', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'AYŞEGÜL KILIÇLI', 'role': 'CONTACT', 'email': 'aysegul_ay_9@hotmail.com', 'phone': '04143186000'}], 'facility': 'Şanlıurfa training and research hospital', 'geoPoint': {'lat': 37.16708, 'lon': 38.79392}}], 'centralContacts': [{'name': 'AYŞEGÜL KILIÇLI, Assisstan. Prof. PhD.', 'role': 'CONTACT', 'email': 'aysegul_ay_9@hotmail.com', 'phone': '(0436) 212 06 70'}, {'name': 'aycan şahin, PhD.', 'role': 'CONTACT', 'email': 'aysegul_ay_9@hotmail.com', 'phone': '(0436) 212 0000'}], 'overallOfficials': [{'name': 'AYŞEGÜL KILIÇLI, Assisstan. Prof. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muş Alparslan University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '15 October 2024- 15 October 2025', 'ipdSharing': 'YES', 'description': 'All', 'accessCriteria': '15 October 2024- 15 October 2025'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aysegul Kilicli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Gaziantep University', 'investigatorFullName': 'Aysegul Kilicli', 'investigatorAffiliation': 'University of Gaziantep'}}}}