Faculty of medicine, Assiut university hospital
Asyut, 71515, Egypt
NCT Number: NCT05957770
The goal of this case control observational study is to asses anxiety, sleep, depression and quality of life in rheumatoid arthritis patients
The main aims are:
* asses anxiety, sleep, depression and quality of life in rheumatoid arthritis patients * their relation to disease activity
we will compare rheumatoid arthritis patients to healthy subjects.
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Notify Me18 year and older
All sexes
Observational
Asyut, 71515, Egypt
All patients were subjected to clinical evaluation (full history and examination, laboratory evaluation (erythrocyte sedimentation rate [ESR], C reactive protein [CRP] and rheumatoid factor [RF]), in addition to assessment of disease activity (disease activity score in 28 joints [DAS28]-ESR
Psychological assessment was performed according to the following scales
Sleep quality assessment was done via
Pittsburgh Sleep Quality Index the first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components (sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use). The scores for each component are summed to get a total score (range 0-21). A score > 5 suggests poor sleep quality.
Assessment of Health status and quality of life via short form health survey (SF36):Thirty-five of the 36 items are grouped into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. One item assesses perception of changes in health over the last year but is not used calculate scale scores. Higher scores indicate high quality of life.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 month
insomnia severity index contains seven domains assessing sleep-onset difficulties, sleep
maintenance, sleep satisfaction, effect on daily functioning, impairment attributed to sleep
problems, and distress associated with insomnia. Each item is rated on a 0-4 scale, and th
e total score ranges from 0 to 28. A higher score suggests more severe insomnia
Time frame: 1 month
Subjects describe how often they fall asleep in certain situations on a scale of 0-3, with total scores ranging from 0 to 24. An ESS score ≥ 10 is indicative of subjective excessive daytime sleepiness and score > 16 indicates high level of daytime sleepiness
Time frame: 1 month
It consists of 14 items and measures both psychic and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where a score ≤ 17 indicates mild anxiety, 18-24 mild to moderate anxiety, , 25-30 moderate to severe anxiety and scores >30 indicate severe anxiety
Time frame: 1 month
The original scale has 21 items, but scoring is based only on the first 17 with total score ranges from 0 to 52. Scores less than or equal to 7 indicates normal response, 8-13 mild depression, 14-18 Moderate, 19-22 severe, and > 22 very severe depression
Time frame: 1 month
Thirty-five of the 36 items are grouped into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. One item assesses perception of changes in health over the last year but is not used calculate scale scores. Mean score ranges from 0 to100. High scores indicate lower disability.
Time frame: 1 month
The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components (sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use). The scores for each component are summed to get a total score (range 0-21). A score > 5 suggests poor sleep quality
Time frame: 1 month
The DAS28 assessment includes a measurement of tender joint count (TJC), swollen joint count (SJC) acute phase reactant (ESR or CRP) and patient's global assessment of disease activity, which is scored from zero to 100 with higher scores indicating active disease. DAS28>5.1 indicates high disease activity. A score 3.5-5.1 indicates moderate disease activity. A score 2.6-3.2 indicates low disease activity and score <2.6 indicates remission. Score ranges from 0 to 9.4
Assiut University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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