Sleep Quality in Patients With Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: no attempt was made to patients

• Registration Number: NCT04278170
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Brief Summary

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

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 Timeline

• Study Start: 2014-05-15
• Primary Completion: 2015-06-15
• Study Completion: 2018-10-15
• Status Verified: 2020-02
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-19
• Last Update Submitted: 2020-02-19
• Study First Posted: 2020-02-20
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case group	no attempt was made to patients	Rheumatoid arthritis patients who met the American College of Rheumatology (ACR) 2010 RA classification

Primary Outcome Measures

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

Trial Locations

Locations (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital; 🇹🇷 Istanbul, Turkey