Sleep Quality in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

An Investigation of Factors Affecting Sleep Quality in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278170
• Other study ID #: TURKEYPMRTRH
• Status: Completed
• Start date: May 15, 2014
• Est. completion date: October 15, 2018

Study information

• Verified date: February 2020
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study was designed to investigate the factors affecting sleep quality of Rheumatoid arthritis patients in Turkish population.

Description:

Demographic data, duration of disease, routine biochemical tests and currently used medications were recorded. Disease activity was assessed with Disease Activity Score 28 (DAS 28). Visual Analog Scale (VAS) was used to evaluate pain levels. Health Assessment Questionnaire (HAQ) was used to assess activities of daily living. Beck depression inventory (BDI) was used to investigate the signs of depression in patients. Sleep quality was considered to be poor in patients with a Pittsburgh Sleep Quality Index (PSQI) global score of 5 and greater.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 15, 2018
• Est. primary completion date: June 15, 2015
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with RA who met the 2010 American College of Rheumatology (ACR) RA classification criteria were included

Exclusion Criteria:

• Patients who had difficulties understanding and responding to questions were excluded from the study.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• no attempt was made to patients
no attempt was made to patients

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine and Rehabilitation Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Goes ACJ, Reis LAB, Silva MBG, Kahlow BS, Skare TL. Rheumatoid arthritis and sleep quality. Rev Bras Reumatol Engl Ed. 2017 Jul - Aug;57(4):294-298. doi: 10.1016/j.rbre.2016.07.011. Epub 2016 Aug 12. English, Portuguese. — View Citation

Purabdollah M, Lakdizaji S, Rahmani A, Hajalilu M, Ansarin K. Relationship between Sleep Disorders, Pain and Quality of Life in Patients with Rheumatoid Arthritis. J Caring Sci. 2015 Sep 1;4(3):233-41. doi: 10.15171/jcs.2015.024. eCollection 2015. — View Citation

Szady P, Baczyk G, Kozlowska K. Fatigue and sleep quality in rheumatoid arthritis patients during hospital admission. Reumatologia. 2017;55(2):65-72. doi: 10.5114/reum.2017.67600. Epub 2017 Apr 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The factor affecting sleep quality of Rheumatoid arthritis patients	Demographic data	1 day
Primary	duration of disease	factor affecting sleep quality of Rheumatoid arthritis patients	1 day
Primary	Sleep quality of Rheumatoid arthritis patients	Pittsburg Sleep Quality Index (PSQI) was used to evaluate the sleep quality of the patients. PSQI is a questionnaire which assesses sleep quality by questioning the patient on 7 main sections; i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep activity, sleep disorders, use of sleep medication and daytime dysfunctions. Questions are scored from 0 to 3, high scores reflecting poor sleep quality. Seven main components are first evaluated individually and then the scores are added. A total score of 5 and above indicates poor sleep quality	1 day
Primary	Disease activity of Rheumatoid arthritis patients	Disease activity was assessed with Disease Activity Score 28 (DAS 28).	1 day
Primary	The pain evaluating of Rheumatoid arthritis patients	Visual Analog Scale (VAS) was used to evaluate pain levels.	1 day
Primary	General health of Rheumatoid arthritis patients	Health Assessment Questionnaire (HAQ) was used to assess activities of daily living.	1 day
Primary	Depression of Rheumatoid arthritis patients	Beck depression inventory (BDI) was used to investigate the signs of depression in patients.	1 day