Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT06744634
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coping Strategies with Pain Among Older People
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': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 336}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A semi-structure questionnaire', 'timeFrame': '1 week', 'description': 'Four main themes were\n\nidentified: (i) the factors affecting pain such as increasing and decreasing factors in ageing; (ii) the coping strategies with pain in ageing; (iii) the management strategies in ageing; (iv) the health related quality of life related pain in ageing'}, {'measure': 'Visuel analog scale', 'timeFrame': '1 week', 'description': 'The VAS is a tool for measuring subjective experiences like pain, discomfort, or other sensations, commonly used with older adults in clinical settings. It helps assess pain intensity, especially in those with communication challenges due to cognitive decline or sensory impairment. VAS is useful for evaluating pain severity in conditions like osteoarthritis, neuropathy, post-surgical pain, and cancer-related pain In this study, participants will rate their pain on an 11-point scale, from 0 (no pain) to 10 (worst pain imaginable). Scores were categorized as severe (7-10), moderate (4-6,9), mild (1-3,9), or no pain (0)'}], 'secondaryOutcomes': [{'measure': 'CDC Health related Quality of Life-4', 'timeFrame': '1 week', 'description': 'develop to assess a person s sense of well-being through four questions. A core set of these measures (the CDC HRQOL-4) asks about self-rated general health and the number of recent days when a person is physically unhealthy, mentally unhealthy, or limited in usual activities.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aged', 'Coping Strategy', 'Health-Related Quality of Life'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Chronic musculoskeletal pain is common among older adults. This study aimed to identify and describe the characteristics of chronic musculoskeletal pain, pain management and coping strategies among older adults from Turkey, Croatia and Romania. The study also aimed to explore cultural differences in pain experience and management.\n\nMethods:\n\n337 older adults with chronic pain participate 100 from Turkey, 131 from Croatia and 106 from Romania. Semi-structured interviews will explore four main topics, including factors influencing pain, coping strategies, management strategies, and health-related quality of life.', 'detailedDescription': 'The questionnaire which was prepared by researchers will be performed by older adults. The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Geriatrics', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women and men aged between 65-85 years\n* living in their own homes or in a nursing home\n* older adults with chronic pain for at least 6 months,\n* independent in activities of daily living, and independent in walking (with or without assistive walking devices).\n\nExclusion Criteria:\n\n* Elderly adults with communication problems'}, 'identificationModule': {'nctId': 'NCT06744634', 'acronym': 'Pain', 'briefTitle': 'Coping Strategies with Pain Among Older People', 'organization': {'class': 'OTHER', 'fullName': 'Biruni University'}, 'officialTitle': 'An Analysis of Factors Associated with Chronic Musculoskeletal Pain, Pain Management Preferences, Coping Strategies and Health-related Quality of Life Among Older People: a Comparative Cross-Cultural Study of Turkey, Croatia and Romania', 'orgStudyIdInfo': {'id': 'Coping strategies'}, 'secondaryIdInfos': [{'id': 'Biruni U', 'type': 'REGISTRY', 'domain': 'Coping strategies with pain'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Romania Group', 'description': 'The structured questionnaire was performed by older adults from Romania', 'interventionNames': ['Other: Romania group']}, {'label': 'Turkey Group', 'description': 'The structured questionnaire was performed by older adults from Turkey', 'interventionNames': ['Other: Turkey Group']}, {'label': 'Croatia Group', 'description': 'The structured questionnaire was performed by older adults from Croatia', 'interventionNames': ['Other: Croatia Group']}], 'interventions': [{'name': 'Romania group', 'type': 'OTHER', 'description': 'The questionnaire which was prepared by researchers will be performed by older adults from Romania. The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire', 'armGroupLabels': ['Romania Group']}, {'name': 'Turkey Group', 'type': 'OTHER', 'description': 'The questionnaire which was prepared by researchers will be performed by older adults from Turkey The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire', 'armGroupLabels': ['Turkey Group']}, {'name': 'Croatia Group', 'type': 'OTHER', 'description': 'The questionnaire which was prepared by researchers will be performed by older adults from Croatia. The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire', 'armGroupLabels': ['Croatia Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34010', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Biruni University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biruni University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assis. Dr.', 'investigatorFullName': 'Eylül Pınar KISA', 'investigatorAffiliation': 'Biruni University'}}}}