Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Systemic Lupus Erythematosus Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- evaluation of excessive daytime sleepiness in SLE patients by Epworth sleepiness scale
研究概览
简要总结
The goal of this case control observational study is to asses anxiety, sleep, depression and quality of life in Systemic Lupus Erythematosus (SLE) patients.
The main aims are:
- asses anxiety, sleep, depression and quality of life in SLE patients
- their relation to disease activity
we will compare SLE patients to healthy subjects.
详细描述
All patients will be subjected to clinical evaluation (full history and examination, laboratory evaluation (include erythrocyte sedimentation rate (ESR) measured by standard westergren method (mm/h), serum C-reactive protein (CRP), complete blood count (CBC), serum urea and creatinine, aspartate transaminase (AST), alanine transaminase (ALT), complete urine analysis for: urinary casts (hyaline, granular), hematuria (RBCs/ high power field), pyuria (WBCs/ high power field), 24-hour urinary protein and creatinine clearance. Immunological work up will include antinuclear antibodies (ANA) by ELISA, anti-double stranded DNA (ds-DNA) by ELISA and complement components C3 and C4 by nephelometry. Disease activity will be assessed via SLE disease activity index (SLEDAI): SLEDAI is based on the presence of 24 descriptors in nine organ systems over the preceding 30 days. Descriptors of SLEDAI are documented as present or absent. Each of the descriptors has a weighted score and the total score of SLEDAI is the sum of all 24 descriptor scores. The total score falls between 0 and 105, with higher scores representing higher disease activity.
Psychological assessment will be performed according to the following scales
- Hamilton Anxiety Rating Scale (HAM-A): 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.
- Hamilton Depression Rating Scale: the original scale has 21 items, but scoring is based only on the first 17. 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.
Sleep quality assessment was done via
- Insomnia severity index (ISI) : 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 the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
- Epworth sleepiness scale : 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with SLE according to the 2012 systemic lupus international collaborating clinics (SLICC) criteria .
排除标准
- •Evidence of end-organ failures such as heart failure, liver cell or renal failure,
- •History of psychological disorders .
结局指标
主要结局
evaluation of excessive daytime sleepiness in SLE patients by Epworth sleepiness scale
时间窗: 3 months
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
evaluation of sleep quality and disturbances in SLE patients by Pittsburgh Sleep Quality Index
时间窗: 3 months
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
Evaluation of insomnia in SLE patients by Insomnia severity index
时间窗: 3 MONTHS
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
evaluation of anxiety in SLE patients by hamilton anxiety rating scale
时间窗: 3 months
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
evaluation of QoL in SLE patients by short form health survey (sf36 )
时间窗: 3 months
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
evaluation of depression in SLE patients by hamilton depression rating scale
时间窗: 3 months
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.
次要结局
- Correlation of disease activity (SLEDAI) with Hamilton anxiety rating scale, Hamilton depression rating scale, Epworth sleepiness scale,Pittsburgh Sleep Quality Index and short form health survey sf 36(3 months)
研究者
Maha Sayed Ibrahim Abdelrahman
Principal investigator
Assiut University