Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 4:51 AM
Study NCT ID:
NCT07037667
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Management of PMS Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026241', 'term': 'Exercise Movement Techniques'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in premenstrual anxiety', 'timeFrame': '12 weeks following end of treatment', 'description': 'State-Trait- Anxiety Inventory for adults (STAI-AD)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Premenstrual', 'Anxiety', 'Pilates exercises'], 'conditions': ['Premenstrual Anxiety']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine the effect of Pilates exercises in management of premenstrual anxiety in adult virgin females.The main question it aims to answer is :\n\nDo Pilates exercises have an effect on premenstrual anxiety? Researcher will compare the effect of Pilates exercises to dietary recommendations as healthy snacks rich in magnesium and vitamin B-6 to see if Pilates exercises have an effect on premenstrual anxiety.\n\nParticipants will :\n\nDo Pilates exercises two times per week for 12 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants are virgins.\n* All of them suffering from moderate and severe premenstrual anxiety.\n* Their BMI is less than 30 km/m2\n* The regularity of their menstrual cycle is 28-35 days.\n\nExclusion Criteria:\n\n* Smoking.\n* Taking any medications for anxiety.\n* Irregular menstruation.'}, 'identificationModule': {'nctId': 'NCT07037667', 'briefTitle': 'New Management of PMS Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Pilates Exercises in Management of Premenstrual Anxiety', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental group', 'description': 'This group will do Pilates exercises as single leg lift 10 rep and one leg circle 5 times in each direction for 15 minutes 2 times per week for 12 weeks and receives dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6.', 'interventionNames': ['Other: Pilates exercises', 'Other: Dietary recommendations']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'This group will receive dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6.', 'interventionNames': ['Other: Dietary recommendations']}], 'interventions': [{'name': 'Pilates exercises', 'type': 'OTHER', 'description': 'Single leg lifts:The participant is in supine lying position with knees bent and feet parallel and hip-width apart. Head, neck and shoulders totally relaxed and arm extended and relaxed beside the body. Then the participant is asked to inhale first without moving her leg then exhale while bringing one leg up towards chest , drawing her pelvic floor and abdominals up and in like gently tightening a belt and maintaining 90 degrees angle at the knee and then put her leg down while inhaling. One leg circle:The participant is in supine lying position with one leg raised towards the ceiling and the other leg on the floor and both knees slightly bent.Then the participant is asked to inhale first without moving her leg and to make sure to use the abdominal muscles to try to maintain a neutral pelvis while doing the exercise then makes a small circle while exhaling and inhale when she completes the circle and reaches the starting position.', 'armGroupLabels': ['Experimental group']}, {'name': 'Dietary recommendations', 'type': 'OTHER', 'description': 'Dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6.', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damanhūr', 'country': 'Egypt', 'facility': 'Elbeheira governorate', 'geoPoint': {'lat': 27.38333, 'lon': 30.95}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's degree student", 'investigatorFullName': 'Summer Kamal Abbas Mabrouk', 'investigatorAffiliation': 'Cairo University'}}}}