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出境医 / 临床实验 / Turkish Version of the Chalder Fatigue Scale: An Investigation of Its Psychometric Properties in Healthy Young Adults

Turkish Version of the Chalder Fatigue Scale: An Investigation of Its Psychometric Properties in Healthy Young Adults

Study Description
Brief Summary:
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.

Condition or disease
Fatigue Healthy

Detailed Description:
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.
Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 353 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Turkish Version of the Chalder Fatigue Scale: An Investigation of Its Psychometric Properties in Healthy Young Adults
Actual Study Start Date : May 15, 2019
Actual Primary Completion Date : January 10, 2020
Actual Study Completion Date : February 7, 2020
Arms and Interventions
Group/Cohort
healthy young adults
healthy young adults
Outcome Measures
Primary Outcome Measures :
  1. The Turkish Version of the Chalder Fatigue Scale [ Time Frame: About 2-3 minutes ]
    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.

  2. The Turkish Version of the Checklist Individual Strength Fatigue Scale [ Time Frame: About 3-4 minutes ]
    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).


Secondary Outcome Measures :
  1. Visual Analog Scale to Evaluate Physical and Mental Fatigue [ Time Frame: About 1 minutes ]
    Self reported physical and mental fatigue severity over the last month. It is scored 0=no fatigue; 10= tired as bad as can be

  2. The Turkish Version of the Pittsburgh Sleep Quality Index [ Time Frame: About 2-3 minutes ]
    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.

  3. The Turkish Version of the Beck Depression Inventory [ Time Frame: About 4-5 minutes ]
    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.

  4. The Turkish Version of the Nottingham Health Profile [ Time Frame: About 4-5 minutes ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Exclusion criteria are determined as individuals with known acute or chronic health conditions and illnesses and who had surgery in the past 6 months.

Further 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.

Contacts and Locations

Locations
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Turkey
Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Ankara, Altındag, Turkey, 06230
Sponsors and Collaborators
Hacettepe University
Investigators
Layout table for investigator information
Principal Investigator: Cigdem Ayhan, Assoc. Prof. Hacettepe University
Study Chair: Ridvan M Adin, R. A. Hacettepe University
Study Chair: Ali N Ceren, R. A. Hacettepe University
Study Chair: Ayla Fil Balkan, Asst. Prof. Hacettepe University
Study Chair: Yeliz Salci, Asst. Prof. Hacettepe University
Study Chair: Kadriye Armutlu, Prof. Hacettepe University
Tracking Information
First Submitted Date May 29, 2019
First Posted Date May 31, 2019
Last Update Posted Date May 26, 2020
Actual Study Start Date May 15, 2019
Actual Primary Completion Date January 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2020)
  • The Turkish Version of the Chalder Fatigue Scale [ Time Frame: About 2-3 minutes ]
    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.
  • The Turkish Version of the Checklist Individual Strength Fatigue Scale [ Time Frame: About 3-4 minutes ]
    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).
Original Primary Outcome Measures
 (submitted: May 29, 2019)
  • The Turkish Version of the Chalder Fatigue Scale [ Time Frame: 30 days ]
    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.
  • The Turkish Version of the Checklist Individual Strength Fatigue Scale [ Time Frame: 14 days ]
    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).
  • Visual Analog Scale to Evaluate Physical and Mental Fatigue [ Time Frame: 30 days ]
    Self reported physical and mental fatigue severity over the last month. It is scored 0=no fatigue; 10= tired as bad as can be
Change History
Current Secondary Outcome Measures
 (submitted: May 21, 2020)
  • Visual Analog Scale to Evaluate Physical and Mental Fatigue [ Time Frame: About 1 minutes ]
    Self reported physical and mental fatigue severity over the last month. It is scored 0=no fatigue; 10= tired as bad as can be
  • The Turkish Version of the Pittsburgh Sleep Quality Index [ Time Frame: About 2-3 minutes ]
    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.
  • The Turkish Version of the Beck Depression Inventory [ Time Frame: About 4-5 minutes ]
    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.
  • The Turkish Version of the Nottingham Health Profile [ Time Frame: About 4-5 minutes ]
    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.
Original Secondary Outcome Measures
 (submitted: May 29, 2019)
  • The Turkish Version of the Pittsburgh Sleep Quality Index [ Time Frame: 30 days ]
    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 bedmates or 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.
  • The Turkish Version of the Beck Depression Inventory [ Time Frame: 7 days ]
    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.
  • The Turkish Version of the Godin-Shephard Leisure Time Physical Activity Questionnaire [ Time Frame: 7 days ]
    It was developed to classify physical activities/exercises performed by adults and to determine their activity levels. Activities were classified into three subgroups, including "strenuous", "moderate" and "light"The frequency and type of activities/exercises performed weekly by individuals were used as criteria while calculating individuals' physical activity/exercise score in the questionnaire: total score = strenuous/exhausting (9 METs × times/week) + moderate (5 METs × times/week) + light (3 METs × times/week).
  • The Turkish Version of the Nottingham Health Profile [ Time Frame: 30 days ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Turkish Version of the Chalder Fatigue Scale: An Investigation of Its Psychometric Properties in Healthy Young Adults
Official Title Turkish Version of the Chalder Fatigue Scale: An Investigation of Its Psychometric Properties in Healthy Young Adults
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Fatigue
  • Healthy
Intervention Not Provided
Study Groups/Cohorts healthy young adults
healthy young adults
Publications *
  • Mota DD, Pimenta CA. Self-report instruments for fatigue assessment: a systematic review. Res Theory Nurs Pract. 2006 Spring;20(1):49-78. Review.
  • 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.
  • 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.
  • 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.
  • 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.
  • Zwarts MJ, Bleijenberg G, van Engelen BG. Clinical neurophysiology of fatigue. Clin Neurophysiol. 2008 Jan;119(1):2-10. Epub 2007 Nov 26. Review.
  • 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.
  • 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. Review.
  • 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. Review.
  • 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.
  • Kücükdeveci AA, McKenna SP, Kutlay S, Gürsel 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.
  • Wood C, Magnello ME, Jewell T. Measuring vitality. J R Soc Med. 1990 Aug;83(8):486-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 21, 2020)
353
Original Estimated Enrollment
 (submitted: May 29, 2019)
560
Actual Study Completion Date February 7, 2020
Actual Primary Completion Date January 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Exclusion criteria are determined as individuals with known acute or chronic health conditions and illnesses and who had surgery in the past 6 months.

Further 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03969667
Other Study ID Numbers GO 19/512
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Cigdem Ayhan, Hacettepe University
Study Sponsor Hacettepe University
Collaborators Not Provided
Investigators
Principal Investigator: Cigdem Ayhan, Assoc. Prof. Hacettepe University
Study Chair: Ridvan M Adin, R. A. Hacettepe University
Study Chair: Ali N Ceren, R. A. Hacettepe University
Study Chair: Ayla Fil Balkan, Asst. Prof. Hacettepe University
Study Chair: Yeliz Salci, Asst. Prof. Hacettepe University
Study Chair: Kadriye Armutlu, Prof. Hacettepe University
PRS Account Hacettepe University
Verification Date May 2020