Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-05 @ 12:49 AM
Study NCT ID:
NCT06896851
Status:
COMPLETED
Last Update Posted:
2025-03-26
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Su Jok on Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004412', 'term': 'Dysmenorrhea'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assesment', 'timeFrame': '" Every hour until 4 hours after the onset of pain on the first day of the cycle (each cycle is 28-35 days) and it will be for 3 cycle.', 'description': 'Pain assessment is made with Visual Analog Scale(0-10 points, high score means pain severity is high) in three menstrual cycles (up to 105 days).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dysmenorrhea', 'pain', 'su jok'], 'conditions': ['Dysmenorrhea']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the effect of Su Jok application in reducing menstrual pain.The main question it aims to answer is\n\n-Is Su Jok practice effective in reducing the severity of dysmenorrhea? The researcher will perform a sham application to see the effect of the application.\n\nParticipants will perform the application on the first day they have pain during their 3 menstrual cycles. They will evaluate and record their pain with VAS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* regular menstrual cycles (21-35 days)\n* have abdominal pain in the last three cycles\n* Those who want to participate in the study as a volunteer\n\nExclusion Criteria:\n\n* have any health problems that may affect the menstrual cycle (ovarian cysts, etc.\n* use hormonal medications'}, 'identificationModule': {'nctId': 'NCT06896851', 'briefTitle': 'The Effect of Su Jok on Dysmenorrhea', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Medipol University'}, 'officialTitle': 'The Effect of Su Jok on Dysmenorrhea:Randomized Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '14.2024fbu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Su Jok Group', 'description': 'Sujok is applied with black pepper seeds to the appropriate point on the hand.', 'interventionNames': ['Other: Su Jok']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo Control Group', 'description': 'Black pepper seeds are applied to the sham point.', 'interventionNames': ['Other: Sham point using']}], 'interventions': [{'name': 'Su Jok', 'type': 'OTHER', 'description': 'a type of acupressure includs hand massage', 'armGroupLabels': ['Su Jok Group']}, {'name': 'Sham point using', 'type': 'OTHER', 'description': 'unrelated point using for acupressing', 'armGroupLabels': ['Placebo Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34758', 'city': 'Istanbul', 'state': 'Ataşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Fenerbahçe University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data can be shared when the research is accepted for publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Proffesor', 'investigatorFullName': 'Hülya Elmalı Şimşek', 'investigatorAffiliation': 'Ankara Medipol University'}}}}