Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT03586804
Status:
UNKNOWN
Last Update Posted:
2018-07-16
First Post:
2018-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postural Sway at Menstrual Cyclus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-12', 'studyFirstSubmitDate': '2018-07-06', 'studyFirstSubmitQcDate': '2018-07-12', 'lastUpdatePostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Postural sway score', 'timeFrame': 'First evaluation: at first minute. Second evauation: Change baseline postural sway score at 15th minutes. Third evaluation: Change baseline postural sway score at 30th minutes.', 'description': 'Postural sway is a swing of the body while a person is standing in upright position.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['menstrual', 'postural sway', 'dual task'], 'conditions': ["Women's Health: Endometriosis"]}, 'descriptionModule': {'briefSummary': 'The study was planned with the aim of comparison of postural sway responses at menstrual cycles in women with and without the dysmenorrheal syndrome.\n\nWomen will stand on a postural sway evaluation system on the first day of the menstrual cycles and a well-being day which they will select. Every participant will be evaluated same tool. They will be assessed for three times at every session: 1st evaluation will be performed at the normal standing position. 2nd evaluation will be performed at the normal standing position while individuals saying the numbers from 200 to 1. 3rd evaluation will be performed at the normal standing position while individuals holding the mini blocks on their hands.', 'detailedDescription': 'The study was planned with the aim of comparison of postural sway responses at menstrual cycles in women with and without the dysmenorrheal syndrome.\n\nWomen will stand on a postural sway evaluation system on the first day of the menstrual cycles and a well-being day which they will select. Every participant will be evaluated with the same tool. They will be assessed for three times at every session: 1st evaluation will be performed at the normal standing position. 2nd evaluation will be performed at the normal standing position while individuals saying the numbers from 200 to 1. 3rd evaluation will be performed at the normal standing position while individuals holding the mini blocks on their hands.\n\nResults will be compared for menstrual cycles and well-being day in women with and without pain at menstrual cycles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with and without pain at menstrual cycles', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have dysmenorrheal syndrome\n* Have menstrual cycle without pain\n\nExclusion Criteria:\n\n* Have another health problem (systemic, neurologic, orthopedic or psychiatric)'}, 'identificationModule': {'nctId': 'NCT03586804', 'briefTitle': 'Postural Sway at Menstrual Cyclus', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Comparison of Postural Sway Responses at Menstrual Cyclus in Women With and Without Dysmenorrheal Syndrome', 'orgStudyIdInfo': {'id': 'TU-216'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women without dysmenorrheal syndrome', 'description': 'women without dysmenorrheal syndrome', 'interventionNames': ['Other: dual task']}, {'label': 'women with dysmenorrheal syndrome', 'description': 'women with dysmenorrheal syndrome', 'interventionNames': ['Other: dual task']}], 'interventions': [{'name': 'dual task', 'type': 'OTHER', 'description': 'mental and motor tasks will be performed while standing. Motor task: holding mini blocks Mental task: Counting the numbers from 200 to 1', 'armGroupLabels': ['women with dysmenorrheal syndrome', 'women without dysmenorrheal syndrome']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof,PhD', 'investigatorFullName': 'hhotaman', 'investigatorAffiliation': 'Hacettepe University'}}}}