Sleep Quality in Patients With Rheumatoid Arthritis

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

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: no attempt was made to patients

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34186
    • Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Rheumatoid arthritis patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group; Rheumatoid arthritis patients who met the American College of Rheumatology (ACR) 2010 RA classification	Other: no attempt was made to patients; no attempt was made to patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The factor affecting sleep quality of Rheumatoid arthritis patients	Demographic data	1 day
duration of disease	factor affecting sleep quality of Rheumatoid arthritis patients	1 day
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
Disease activity of Rheumatoid arthritis patients	Disease activity was assessed with Disease Activity Score 28 (DAS 28).	1 day
The pain evaluating of Rheumatoid arthritis patients	Visual Analog Scale (VAS) was used to evaluate pain levels.	1 day
General health of Rheumatoid arthritis patients	Health Assessment Questionnaire (HAQ) was used to assess activities of daily living.	1 day
Depression of Rheumatoid arthritis patients	Beck depression inventory (BDI) was used to investigate the signs of depression in patients.	1 day

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Investigators: Study Director: Aysenur Bardak, MD, Istanbul Physical Therapy and Rehabilitation Research and Training Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2014
• Primary Completion (Actual): June 15, 2015
• Study Completion (Actual): October 15, 2018

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: sleep quality; sleeping disorders
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: TURKEYPMRTRH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No