NCT03969667

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

May 29, 2019

Last Update Submit

May 21, 2020

Conditions

Keywords

fatigueassessmentreliabilityvalidityChalder Fatigue ScaleTurkish versionhealthy young adults

Outcome Measures

Primary Outcomes (2)

  • 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.

    About 2-3 minutes

  • 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).

    About 3-4 minutes

Secondary Outcomes (4)

  • Visual Analog Scale to Evaluate Physical and Mental Fatigue

    About 1 minutes

  • The Turkish Version of the Pittsburgh Sleep Quality Index

    About 2-3 minutes

  • The Turkish Version of the Beck Depression Inventory

    About 4-5 minutes

  • The Turkish Version of the Nottingham Health Profile

    About 4-5 minutes

Study Arms (1)

healthy young adults

healthy young adults

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Ankara, Altındag, 06230, Turkey (Türkiye)

Location

Related Publications (12)

  • 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: 16544894BACKGROUND
  • 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: 30839335BACKGROUND
  • 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: 9117043BACKGROUND
  • 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: 28806984BACKGROUND
  • 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: 20630259BACKGROUND
  • 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: 18039594BACKGROUND
  • 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: 8463991BACKGROUND
  • 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: 11124735BACKGROUND
  • 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: 15016573BACKGROUND
  • 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: 22324761BACKGROUND
  • 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: 10826123BACKGROUND
  • Wood C, Magnello ME, Jewell T. Measuring vitality. J R Soc Med. 1990 Aug;83(8):486-9. doi: 10.1177/014107689008300803.

    PMID: 2231574BACKGROUND

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cigdem Ayhan, Assoc. Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate doctor

Study Record Dates

First Submitted

May 29, 2019

First Posted

May 31, 2019

Study Start

May 15, 2019

Primary Completion

January 10, 2020

Study Completion

February 7, 2020

Last Updated

May 26, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations