Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-20 @ 6:01 PM
Study NCT ID:
NCT03969667
Status:
COMPLETED
Last Update Posted:
2020-05-26
First Post:
2019-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Turkish Version of the Chalder Fatigue Scale: An Investigation of Its Psychometric Properties in Healthy Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-21', 'size': 84636, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-21T11:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 353}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-21', 'studyFirstSubmitDate': '2019-05-29', 'studyFirstSubmitQcDate': '2019-05-29', 'lastUpdatePostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Turkish Version of the Chalder Fatigue Scale', 'timeFrame': 'About 2-3 minutes', 'description': 'The Chalder Fatigue Scale has a 7-item physical fatigue subscale and 4 items of mental fatigue subscale. The scale evaluates the severity of physical and mental fatigue over the last month. Each item is scored 0-3 (0=less than usual, 3=much more than usual), yielding a total between 0 and 33.'}, {'measure': 'The Turkish Version of the Checklist Individual Strength Fatigue Scale', 'timeFrame': 'About 3-4 minutes', 'description': 'The scale evaluates fatigue over the past two weeks.The questionnaire consists of 20 items with a 7-point Likert scale scoring. A total score is derived by summation of the item scores (20-140). There are four subscales; Fatigue Severity, measuring the subjective experience of fatigue (8 items); Concentration, measuring concentration problems (5 items); Motivation, measuring reduced motivation (4 items) and Activity, measuring the reduction of activities (3 items).'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale to Evaluate Physical and Mental Fatigue', 'timeFrame': 'About 1 minutes', 'description': 'Self reported physical and mental fatigue severity over the last month. It is scored 0=no fatigue; 10= tired as bad as can be'}, {'measure': 'The Turkish Version of the Pittsburgh Sleep Quality Index', 'timeFrame': 'About 2-3 minutes', 'description': "The scale assesses sleep quality over a 1-month period. The questionnaire consists of 19 self-rated questions and 5 questions that should be answered by roommates. The latter questions are used only for clinical information. The 19 questions are categorized into 7 components, graded on a score that ranges from 0 to 3. The scale's components are as follows: subjective sleep quality (C1), sleep latency (C2), sleep duration (C3), habitual sleep efficiency (C4), sleep disturbances (C5), use of sleeping medication (C6) and daytime dysfunction (C7). The sum of scores for these 7 components yields one global score, which ranges from 0 to 21, where the highest score indicates worst sleep quality."}, {'measure': 'The Turkish Version of the Beck Depression Inventory', 'timeFrame': 'About 4-5 minutes', 'description': 'It is a 21-item self-report questionnaire for assessing the severity of depressive symptoms over past week; the items comprise four ordinal categories (from 0 through 3). Absence (or "as usual") of depressive symptom in each item is scored as "0" and presence of symptom is scored between 1 and 3, with the higher score indicating more intense symptom severity. The possible total score ranges from 0 to 63.'}, {'measure': 'The Turkish Version of the Nottingham Health Profile', 'timeFrame': 'About 4-5 minutes', 'description': 'The scale measures subjective health status using 38 items that assess 6 subscales (physical mobility, pain, energy level, sleep, emotional reaction and social isolation); each question answered by (yes) or (no) with each question assigned a weighted value. Scores for each section can range from 0 "no problems" to 100 "all problems listed are present" where the sum of all weighted values in a given subscale adds up to 100.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fatigue', 'assessment', 'reliability', 'validity', 'Chalder Fatigue Scale', 'Turkish version', 'healthy young adults'], 'conditions': ['Fatigue', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '16544894', 'type': 'BACKGROUND', 'citation': 'Mota DD, Pimenta CA. Self-report instruments for fatigue assessment: a systematic review. Res Theory Nurs Pract. 2006 Spring;20(1):49-78. doi: 10.1891/rtnp.20.1.49.'}, {'pmid': '30839335', 'type': 'BACKGROUND', 'citation': 'Beydoun J, Nasrallah L, Sabrah T, Caboral-Stevens M. Towards a Definition of Caregiver Fatigue: A Concept Analysis. ANS Adv Nurs Sci. 2019 Oct/Dec;42(4):297-306. doi: 10.1097/ANS.0000000000000262.'}, {'pmid': '9117043', 'type': 'BACKGROUND', 'citation': 'Glaus A, Crow R, Hammond S. A qualitative study to explore the concept of fatigue/tiredness in cancer patients and in healthy individuals. Eur J Cancer Care (Engl). 1996 Jun;5(2 Suppl):8-23. doi: 10.1111/j.1365-2354.1996.tb00247.x.'}, {'pmid': '28806984', 'type': 'BACKGROUND', 'citation': 'Engberg I, Segerstedt J, Waller G, Wennberg P, Eliasson M. Fatigue in the general population- associations to age, sex, socioeconomic status, physical activity, sitting time and self-rated health: the northern Sweden MONICA study 2014. BMC Public Health. 2017 Aug 14;17(1):654. doi: 10.1186/s12889-017-4623-y.'}, {'pmid': '20630259', 'type': 'BACKGROUND', 'citation': 'Cella M, Chalder T. Measuring fatigue in clinical and community settings. J Psychosom Res. 2010 Jul;69(1):17-22. doi: 10.1016/j.jpsychores.2009.10.007. Epub 2009 Dec 11.'}, {'pmid': '18039594', 'type': 'BACKGROUND', 'citation': 'Zwarts MJ, Bleijenberg G, van Engelen BG. Clinical neurophysiology of fatigue. Clin Neurophysiol. 2008 Jan;119(1):2-10. doi: 10.1016/j.clinph.2007.09.126. Epub 2007 Nov 26.'}, {'pmid': '8463991', 'type': 'BACKGROUND', 'citation': 'Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP. Development of a fatigue scale. J Psychosom Res. 1993;37(2):147-53. doi: 10.1016/0022-3999(93)90081-p.'}, {'pmid': '11124735', 'type': 'BACKGROUND', 'citation': 'Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.'}, {'pmid': '15016573', 'type': 'BACKGROUND', 'citation': 'Dittner AJ, Wessely SC, Brown RG. The assessment of fatigue: a practical guide for clinicians and researchers. J Psychosom Res. 2004 Feb;56(2):157-70. doi: 10.1016/S0022-3999(03)00371-4.'}, {'pmid': '22324761', 'type': 'BACKGROUND', 'citation': 'Ergin G, Yildirim Y. A validity and reliability study of the Turkish Checklist Individual Strength (CIS) questionnaire in musculoskeletal physical therapy patients. Physiother Theory Pract. 2012 Nov;28(8):624-32. doi: 10.3109/09593985.2011.654321. Epub 2012 Feb 10.'}, {'pmid': '10826123', 'type': 'BACKGROUND', 'citation': 'Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.'}, {'pmid': '2231574', 'type': 'BACKGROUND', 'citation': 'Wood C, Magnello ME, Jewell T. Measuring vitality. J R Soc Med. 1990 Aug;83(8):486-9. doi: 10.1177/014107689008300803.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to adapt the Chalder Fatigue Scale to Turkish and to examine its psychometric properties in young adults. Within the scope of the study, firstly the Turkish version of the scale will be developed and then its reliability and validity will be examined in healthy young adults in Turkey.', 'detailedDescription': 'Fatigue is a subjective experience that can affect all individuals. It is a protective symptom against physical or psychological stress for healthy individuals. However, it can negatively affect the performance of individuals in activities of daily living. In the clinic, fatigue is assessed by self-reported scales. Different fatigue scales have some advantages and disadvantages compared to each other. Moreover, it is stated that only one scale cannot fully measure the fatigue of individuals in different health status, therefore different scales have been developed.Chalder Fatigue Scale (CFS) is an easy-to-understand, short, fast and useful fatigue scale that evaluates fatigue with two dimensions (physical and mental) and enable individuals to express perceived fatigue clearly. Psychometric properties of CFS have been investigated in general population and different disease groups but not in only healthy young adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample: The sample of the study consisted of healthy young adults, who could be announced / informed about the study and volunteered to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'The inclusion criteria for participants are: to be aged between 20 and 40 years old, volunteer to participate the study, able to read and speak Turkish.\n\nExclusion criteria are determined as individuals with known acute or chronic health conditions and illnesses and who had surgery in the past 6 months.\n\nFurther exclusion criteria are to take over-the-counter medication or food supplement, have abnormal body mass index (BMI) (lower 17 kg/m2 or higher 30 kg/m2), self reported depression as indicated by a score of \\> 21 on the Beck Depression Scale (BDS), pain as indicated by a score of \\> 0 on pain subscale of Nottingham Health Profile (NHP). Additionally, female participants were excluded if they use oral contraceptives, experience premenstrual syndrome or were pregnant within the last one year period.'}, 'identificationModule': {'nctId': 'NCT03969667', 'briefTitle': 'Turkish Version of the Chalder Fatigue Scale: An Investigation of Its Psychometric Properties in Healthy Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Turkish Version of the Chalder Fatigue Scale: An Investigation of Its Psychometric Properties in Healthy Young Adults', 'orgStudyIdInfo': {'id': 'GO 19/512'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy young adults', 'description': 'healthy young adults'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'state': 'Altındag', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Cigdem Ayhan, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}, {'name': 'Ridvan M Adin, R. A.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Ali N Ceren, R. A.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Ayla Fil Balkan, Asst. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Yeliz Salci, Asst. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Kadriye Armutlu, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate doctor', 'investigatorFullName': 'Cigdem Ayhan', 'investigatorAffiliation': 'Hacettepe University'}}}}