Clinical trial NCT04278170: Sleep Quality in Patients With Rheumatoid Arthritis
Official title: An Investigation of Factors Affecting Sleep Quality in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: sleeping disorders
sleep quality
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The factor affecting sleep quality of Rheumatoid arthritis patients
timeFrame: 1 day
measure: duration of disease
timeFrame: 1 day
measure: Sleep quality of Rheumatoid arthritis patients
timeFrame: 1 day
measure: Disease activity of Rheumatoid arthritis patients
timeFrame: 1 day
measure: The pain evaluating of Rheumatoid arthritis patients
timeFrame: 1 day
measure: General health of Rheumatoid arthritis patients
timeFrame: 1 day
measure: Depression of Rheumatoid arthritis patients
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Study officials:
affiliation: Istanbul Physical Therapy and Rehabilitation Research and Training Hospital
name: Aysenur Bardak, MD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.