Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT07106905
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2025-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Back Pain in Mothers of Children With Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '. Beck Depression Inventory', 'timeFrame': 'Baseline', 'description': 'It is a scale consisting of 21 items that measures depressive symptoms. A maximum of 63 points can be obtained, with higher scores indicating an increase in depression.'}, {'measure': 'Physical Workload Questionnaire', 'timeFrame': 'Baseline', 'description': 'A 19-item Likert scale with scores ranging from 0 to 4, developed to identify the load on the lumbar region during work activities. Higher scores indicate increased work load.'}, {'measure': 'Handgrip strength measurement', 'timeFrame': 'Baseline', 'description': 'This measurement was performed on the dominant hand while the participant was seated in a chair in the standard position defined by the American Hand Therapy Association. They were asked to squeeze the dynamometer as hard as possible. The average of three measurements taken at 30-second intervals was recorded in pounds.'}], 'secondaryOutcomes': [{'measure': '1-10 Numerical Pain Rating Scale (NPRS)', 'timeFrame': 'Baseline', 'description': 'The NPRS was used to determine the severity of low back pain reported at the time of assessment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Mothers of children with disabilities.', 'Handgrip strength', 'Physical workload', 'Depression'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This is a cross-sectional study that aims to determine the prevalence of low back pain in mothers of children with disabilities following the COVID-19 pandemic and to describe its relationship with exposure to the virus, handgrip strength, physical workload, and depression.', 'detailedDescription': 'Low back pain is a very common problem in mothers of children with disabilities. Musculoskeletal pain have been on the rise with COVID-19 but the effects of the pandemic on the prevalence of low back pain in mothers of children with disabilities have not been investigated. The relationship between handgrip strength and low back pain is well known. There are limited studies investigating handgrip strength or muscle strength in mothers of children with disabilities, and no studies examining the relationship between handgrip strength and low back pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mothers of Children with Disabilities', 'genderDescription': 'Mothers of Children with Disabilities', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteering to participate in the study\n* Having a disabled child\n* Being responsible for the care of a disabled child\n* Having provided care for a disabled child for at least one year\n\nExclusion Criteria:\n\n* Having more than one disabled child and being responsible for their care\n* Having previously undergone surgery on the lower back\n* Having a previous upper extremity disorder\n* Receiving psychological treatment or medication\n* Being pregnant or having recently given birth\n* Having a recent history of trauma to the musculoskeletal system\n* Having a defined chronic illness'}, 'identificationModule': {'nctId': 'NCT07106905', 'briefTitle': 'Low Back Pain in Mothers of Children With Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'Relationships Between Handgrip Strength, Physical Workload, Depression, and Low Back Pain in Mothers of Children With Disabilities Following COVID-19 Pandemic', 'orgStudyIdInfo': {'id': 'SCU-FTR-SBF-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mothers of children with disabilities', 'interventionNames': ['Other: Measurements']}], 'interventions': [{'name': 'Measurements', 'type': 'OTHER', 'description': 'These measurements are used in other clinical applications. However, the effectiveness of these measurements in discriminating the presence of low back pain in mothers of children with disabilities over the past year has been identified.', 'armGroupLabels': ['Mothers of children with disabilities']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58140', 'city': 'Sivas', 'country': 'Turkey (Türkiye)', 'facility': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Sivas Cumhuriyet University', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selvin BALKİ', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cumhuriyet University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Ph.D.', 'investigatorFullName': 'Selvin BALKİ', 'investigatorAffiliation': 'Cumhuriyet University'}}}}