Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-31 @ 5:53 PM
Study NCT ID:
NCT06558266
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2024-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mental Imagery in Menstrual Cycle Phases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-08-15', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Imagery Skill', 'timeFrame': 'In 1 month period', 'description': "The Vividness of Movement Imagery Questionnaire-2 will be used to assess the vividness of participants' movement imagery ability. In the questionnaire, a total of 12 different actions are imagined, and the questionnaire has three subscales (Internal Visual Imagery, External Visual Imagery, and Kinesthetic Imagery). A 5-point Likert scale (1: Perfectly clear and vivid as a normal vision - 5: No image at all: Only know you are thinking of the movement) is used to score each action, and the total score for each subscale ranges from 1 to 60."}], 'secondaryOutcomes': [{'measure': 'Menstrual Symptoms', 'timeFrame': 'at baseline', 'description': "The Menstruation Symptom Scale is one of the scales that evaluates the symptoms experienced due to menstruation in detail. It is a five-point Likert-type scale consisting of twenty-four items. Participants are asked to give a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. The MSÖ score is calculated by taking the total score average of the items in the scale. An increase in the score average indicates an increase in the severity of menstrual symptoms. The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints', 'Menstrual Pain' and 'Abdominal Pain'. The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the sub-dimensions."}, {'measure': 'Menstrual Pain', 'timeFrame': 'at baseline', 'description': 'The numbered classification scale-11 (NSS-11) (0-10) will be used to evaluate menstrual pain. It is a practical and simple method recommended to evaluate the severity and variations of menstrual pain. The participant will be asked to give a score between 0-10 for the severity of pain they perceive/feel during menstruation. "0 means no complaints", "10 means very severe complaints"'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menstruation', 'Mental Imagery', 'Menstrual Cycles']}, 'descriptionModule': {'briefSummary': 'Hormonal fluctuations occur during the menstrual cycle and can affect cognition. For example, an increase in estrogen levels has been reported to temporarily enhance auditory perception of newly formed stimuli. It has been suggested that fluctuations in hormone levels can alter cognitive performance throughout the menstrual cycle because these fluctuations impact the neurobiology of the brain regions involved in cognition and emotion processing. Mental imagery (MI) refers to the mental process in which an individual imagines performing a movement without actually executing the movement. The effects of hormonal fluctuations on cognitive-perceptual skills have been mentioned above. In light of the above information, this study was planned to examine the relationship between menstrual symptom characteristics and mental imagery ability and to compare women s mental imagery abilities according to the phases of the menstrual cycle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The universe of the study consists of female students studying at Izmir University of Economics. With the permission of the Dean of the Faculty of Health Sciences of Izmir University of Economics, an announcement e-mail will be sent to all female students to inform them about the study and a list of volunteers will be created via the participation link. 151 female students who meet the study criteria will be included with the systematic sampling method. An "Informed Volunteer Consent Form" will be obtained from individuals who accept to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* Being a woman between the ages of 18-25,\n* Having a regular menstrual cycle,\n* Being a volunteer Exclusion criteria\n* Using neuropsychiatric medication that may affect perception and cognitive skills.\n\nPeople who do not participate in any of the four assessments will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06558266', 'briefTitle': 'Mental Imagery in Menstrual Cycle Phases', 'organization': {'class': 'OTHER', 'fullName': 'Izmir University of Economics'}, 'officialTitle': 'Comparison of Mental Imagery Ability According to Menstrual Cycle Phases', 'orgStudyIdInfo': {'id': 'B.30.2.İEÜSB.0.05.05-20-291'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'menstrual cycle monitoring group', 'description': 'Female students between 18-25 with regular menstrual cycles', 'interventionNames': ['Other: Since this was an observational study, no intervention was performed.']}], 'interventions': [{'name': 'Since this was an observational study, no intervention was performed.', 'type': 'OTHER', 'description': 'Since it is an observational study, only evaluation will be made. Each participant s mental imagery ability will be evaluated with the Movement Imagery Vividness Questionnaire-2 four times, follicular phase, ovulation, luteal phase and menstrual phase. In addition, the pain intensity experienced during menstruation will be evaluated with the Numerical Classification Scale-11, and the symptoms experienced due to menstruation will be evaluated with the Menstruation Symptom Scale.', 'armGroupLabels': ['menstrual cycle monitoring group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35330', 'city': 'Izmir', 'state': 'İzmir', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir University of Economics', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Seda Yakıt Yeşilyurt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izmir University of Economics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir University of Economics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'Seda Yakit Yesilyurt', 'investigatorAffiliation': 'Izmir University of Economics'}}}}