Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 5:03 PM
Study NCT ID:
NCT05569694
Status:
UNKNOWN
Last Update Posted:
2023-07-24
First Post:
2022-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Movement-Based Pelvic Health Education for Women in Underserved Communities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2022-10-04', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge Acquisition', 'timeFrame': '1 month', 'description': "Participants complete a questionnaire pre, post, and one-month following the intervention. The questionnaire includes true/false questions: 10 general knowledge, 10 underactive pelvic floor, 10 overactive pelvic floor. The more correct answers the participant submits, the higher the score. Answer options: True, False, I don't know."}], 'secondaryOutcomes': [{'measure': 'Exercise Adherence', 'timeFrame': '1 month', 'description': 'Participants complete a questionnaire pre-session and one-month following the intervention. The questionnaire included questions related to the number of times per week the participant implemented pelvic floor movements and options were:\n\nNever less than once a week about once a week 2 or 3 times a week at least once a day twice on most days twice each day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Women's health", 'Community education', 'Underserved population'], 'conditions': ['Pelvic Floor Muscle Weakness', 'Pelvic Pain']}, 'descriptionModule': {'briefSummary': "It is essential to provide the community with evidenced-based care to optimize healthcare outcomes; more specifically, women in underserved communities undergoing health disparities in rehabilitation. To address this issue, a movement-based pelvic health education course was developed to assess women's knowledge and adherence of the exercises in an underserved region in Western Arkansas.The purpose of this research was to determine the effectiveness of a single movement-based pelvic health education session on general pelvic health knowledge, underactive pelvic floor, and overactive pelvic floor knowledge and adherence to performing pelvic exercises in women."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* female-identifying\n* ability to speak English or provide own translator\n* ability to complete the questionnaires\n* clearance from physician if pregnant\n* access to internet\n\nExclusion Criteria:\n\n-Experiencing pelvic pain and/or pregnant and does not have physician clearance to participate'}, 'identificationModule': {'nctId': 'NCT05569694', 'acronym': 'PHEd', 'briefTitle': 'Movement-Based Pelvic Health Education for Women in Underserved Communities', 'organization': {'class': 'OTHER', 'fullName': 'Arkansas Colleges of Health Education'}, 'officialTitle': 'Pelvic Health Education for Women in Underserved Communities', 'orgStudyIdInfo': {'id': 'Kendrick PH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Women in the Community', 'description': 'Movement-Based pelvic health education', 'interventionNames': ['Other: Movement-based pelvic health education']}], 'interventions': [{'name': 'Movement-based pelvic health education', 'type': 'OTHER', 'description': 'A single virtual education session led by a physical therapist trained in pelvic health. The virtual course was approximately one hour and included movement-based education through various positions, exercises, and movements with explanations for each pose as it relates to pelvic health.', 'armGroupLabels': ['Women in the Community']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Colleges of Health Education', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arkansas Colleges of Health Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Physical Therapy', 'investigatorFullName': 'Alexis Kendrick', 'investigatorAffiliation': 'Arkansas Colleges of Health Education'}}}}