Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT04742335
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2021-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Pain, Occupational Fatigue, Sleep and Quality of Life in Nurses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018771', 'term': 'Arthralgia'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nordic Musculoskeletal Questionnaire scores', 'timeFrame': '1 month', 'description': 'whether symptoms of pain, pain and discomfort have been experienced in the neck, shoulder, elbow, hand-wrist, waist, back, hip-thigh, knee-foot-ankle regions during the last 12 months and whether ordinary indoor and outdoor activities are hampered by these symptoms and whether there has been pain in the mentioned body areas for the last 7 days.'}, {'measure': 'Occupational Fatigue Exhaustion Recovery Scale scores', 'timeFrame': '1 month', 'description': 'İt evaluates chronic fatigue, acute fatigue and recovery.'}, {'measure': 'Sleep Hygiene Index score', 'timeFrame': '1 month', 'description': 'It evaluates sleep hygiene.'}, {'measure': 'WHOQOL-BREF-TR scores', 'timeFrame': '1 month', 'description': 'It evaluates the well-being of individuals in physical health, psychological status, social relations and environmental conditions and their general quality of life and health status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain in A Joint, Multiple Sites']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the pain, occupational fatigue, sleep and quality of life in nurses and the relationships between them. 102 participants working as nurses were included in the study. Data on age, gender, height, weight, working year in the profession, weekly working hours, hand dominance, diagnosed diseases and marital status of the participants were collected. Subsequently, the questions included in the Nordic musculoskeletal questionnaire, occupational fatigue / burnout / recovery scale (OFER), sleep hygiene index (SHI) and World Health Organization quality of life scale (WHOQOL-BREF) questionnaires were answered by the participants.', 'detailedDescription': 'Nordic Musculoskeletal Questionnaire: It is a scale that evaluates whether symptoms of pain, pain and discomfort have been experienced in the neck, shoulder, elbow, hand-wrist, waist, back, hip-thigh, knee-foot-ankle regions during the last 12 months and whether ordinary indoor and outdoor activities are hampered by these symptoms and whether there has been pain in the mentioned body areas for the last 7 days. It consists of 27 items and each item is answered as yes / no.\n\nOccupational Fatigue Exhaustion Recovery Scale: It is a scale developed to measure occupational fatigue. It consists of 15 items in total and 3 sub-dimensions evaluating chronic fatigue (questions 1-5), acute fatigue (questions 6-10) and recovery (questions 11-15). Each item is scored between 0-6 points (0 = Strongly Disagree, 1 = Disagree, 2 = Somewhat Disagree, 3 = Neither agree nor disagree, 4 = slightly agree, 5 = Agree, 6 = Strongly Agree) by the participants. High scores in the chronic and acute fatigue sub-dimensions mean higher occupational fatigue, and higher scores in the recovery sub-dimension mean better recovery between working periods.\n\nSleep Hygiene Index: It is a scale that evaluates sleep hygiene. The frequencies of sleep hygiene-related behaviors are questioned in a total of 13 items with a Likert-type scale where each item is scored between 0 and 4 (0 = never, 1 = rarely, 3 = sometimes, 4 = often, 5 = always). Higher scores indicate worse sleep hygiene.\n\nWHOQOL-BREF-TR: It is a scale that evaluates the well-being of individuals in 4 sub-areas in which physical health, psychological status, social relations and environmental conditions are questioned, and their general quality of life and health status with one question. Each item is scored on a 1-5 Likert-type scale. Sub-domain scores represent the quality of life in their field independently of each other. Higher scores indicate better quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '102 volunteer nurses over 18 years old.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over 18 years old\n* Working as a nurse\n\nExclusion Criteria:\n\n* Being under the age of 18\n* Having a history of serious trauma and orthopedic surgery in the last 1 year\n* Having a chronic severe internal and neurological disease'}, 'identificationModule': {'nctId': 'NCT04742335', 'briefTitle': 'Assessment of Pain, Occupational Fatigue, Sleep and Quality of Life in Nurses', 'organization': {'class': 'OTHER', 'fullName': 'Ufuk University'}, 'officialTitle': 'Assessment of Pain, Occupational Fatigue, Sleep and Quality of Life in Nurses', 'orgStudyIdInfo': {'id': '2020-3-17'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'Survey will be applied to the participants.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'Ankara', 'state': 'Çankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Ufuk University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ufuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor Lecturer', 'investigatorFullName': 'Elzem Bolkan Günaydın', 'investigatorAffiliation': 'Ufuk University'}}}}