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FatigueNCT03969667

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

An observational study of Fatigue and Healthy, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Fatigue, Healthy
How many people
353 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2019to 7 Feb 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

    Ankara, Altındag, 06230

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Conditions
Fatigue, Healthy
Keywords
fatigue, assessment, reliability, validity, Chalder Fatigue Scale, Turkish version, healthy young adults
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03969667
Study groupRoleWhat they receive
healthy young adultshealthy young adults

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Turkish Version of the Chalder Fatigue Scale

    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.

    Measured: About 2-3 minutes

  2. The Turkish Version of the Checklist Individual Strength Fatigue Scale

    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).

    Measured: About 3-4 minutes

Secondary outcomes (4)

  1. Visual Analog Scale to Evaluate Physical and Mental Fatigue

    Self reported physical and mental fatigue severity over the last month. It is scored 0=no fatigue; 10= tired as bad as can be

    Measured: About 1 minutes

  2. The Turkish Version of the Pittsburgh Sleep Quality Index

    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.

    Measured: About 2-3 minutes

  3. The Turkish Version of the Beck Depression Inventory

    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.

    Measured: About 4-5 minutes

  4. The Turkish Version of the Nottingham Health Profile

    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.

    Measured: About 4-5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2019
  2. Study start15 May 2019
  3. Primary completion10 Jan 2020
  4. Study completion7 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03969667
Sponsor's protocol ID
GO 19/512
Status last verified
May 2020
First submitted
29 May 2019
Last updated
26 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16544894

  • 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.

    PubMed 30839335

  • 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.

    PubMed 9117043

  • 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.

    PubMed 28806984

  • 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.

    PubMed 20630259

  • 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.

    PubMed 18039594

  • 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.

    PubMed 8463991

  • 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.

    PubMed 11124735

  • 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.

    PubMed 15016573

  • 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.

    PubMed 22324761

  • 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.

    PubMed 10826123

  • Wood C, Magnello ME, Jewell T. Measuring vitality. J R Soc Med. 1990 Aug;83(8):486-9. doi: 10.1177/014107689008300803.

    PubMed 2231574

Questions about this trial

What is this clinical trial studying?

An observational study of Fatigue and Healthy, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Turkish Version of the Chalder Fatigue Scale (time frame: About 2-3 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03969667, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.

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