Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT04543435
Status:
COMPLETED
Last Update Posted:
2021-01-08
First Post:
2020-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Pain Coping Methods and Related Factors in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-07', 'studyFirstSubmitDate': '2020-09-02', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'McGill Pain Questionnaire', 'timeFrame': '15 minutes', 'description': 'This tool is used for assesment of pain, namely; body part of pain, timeframe, characteristic and severity of pain. As score increases, pain condition worsens.'}, {'measure': 'Pain Coping Inventory (PCI)', 'timeFrame': '10 minutes', 'description': 'This tool is used for assessment of pain coping strategies. The higher score received means that coping strategy is used more.'}, {'measure': 'Timed up and go test', 'timeFrame': '5 minutes', 'description': 'This tool is used for assessment of functional mobility. The duration to complete the task (in seconds) is used as a score. As the score increase, the functional mobility decrease.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postmenopausal', 'pain coping'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Musculoskeletal pain (MSP) reflects of musculoskeletal conditions related to tissues such as tendons, muscles, ligaments, nerves, and other joint structures. Coping strategies with pain are used to manage the pain and its impacts. The present study aimed to compare active and passive coping strategies used and pain severity in postmenopausal women according to their demographic characteristics. Also, the relationship between pain and coping strategies in postmenopausal women with cMSP will be examined.', 'detailedDescription': 'Musculoskeletal pain (MSP) reflects of musculoskeletal conditions related to tissues such as tendons, muscles, ligaments, nerves, and other joint structures. If MSP lasts for longer than three months, it becomes chronic. The prevalence of chronic MSP (cMSP) increases with aging and its ratio changes between 35,7% and 49,8%. The previous studies demonstrated the differences in the prevalence of cMSP between men and women. According to most of the studies, older women adults are more vulnerable to experience than men due to some differences in perception of pain such as biological characteristics, their roles in daily life, beliefs or coping strategies with pain.\n\nOestrogen has a prominent role in the physiology of muscles, tendons, ligaments, and bones. The decline of this sex hormone during menopause transition could lead to MSP, particularly in the postmenopausal period. Indeed, an increasing rate of cMSP in postmenopausal women has been reported.\n\nCoping strategies with pain are used to manage the pain and its impacts. Coping with pain requires the self-regulation of individuals using cognitive and behavioral reactions. Dealing with cMSP is a process that can need the making of changes in daily life and activities This study aimed to compare active and passive coping strategies being used and pain severity in postmenopausal women according to their age, marital status, educational status, and exercise habits. Also, subdomains of strategies and subdomains of pain and the relationship between pain and coping strategies in postmenopausal women with cMSP will be examined.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presented to a rehabilitation clinic with complaints of pain in anywhere of their body and who are volunteer for the study will be included. Informed consent will be signed by the participants.', 'genderDescription': 'Postmenopausal women will be included.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* complaints of pain in anywhere of their body.\n* presenting at least 1 year of amenorrhea\n* being between the ages of 50-69 years.\n\nExclusion Criteria:\n\n* have rheumatological, orthopedic and neurological diseases,\n* have compression fractures, malignancies,\n* have a chronic disease that will lead to secondary osteoporosis,\n* have a drug use that will lead to secondary osteoporosis'}, 'identificationModule': {'nctId': 'NCT04543435', 'briefTitle': 'Investigation of Pain Coping Methods and Related Factors in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'European University of Lefke'}, 'officialTitle': 'Investigation of Pain Coping Methods and Related Factors in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'ÜEK/47/01/12/1920/05'}}, 'contactsLocationsModule': {'locations': [{'city': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'European University of Lefke', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'overallOfficials': [{'name': 'Beliz B Kaygısız, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European University of Lefke'}, {'name': 'Nuray Elibol', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ege University'}, {'name': 'Sevim Acaröz Candan', 'role': 'STUDY_CHAIR', 'affiliation': 'Ordu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European University of Lefke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}