Effect of Sleep Quality on Disability and Functional Impairment among individuals with Chronic Spinal Cord Injury: A Prospective Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
Spinal cord injury (SCI) is a life-altering condition that leads to varying degrees of paralysis and disability, depending on the level and extent of the injury. Sleep disturbances are common in people with SCI due to a variety of factors including pain, spasticity, medication side effects, neurogenic bladder, and respiratory complications. Existing evidence suggests that poor sleep quality is associated with a wide range of negative outcomes, including increased pain perception, fatigue, mood disorders, and cognitive impairments. However, there is a lack of comprehensive research directly linking sleep quality with the specific dimensions of disability and functional limitations in individuals with chronic SCI.
The functional capacity and independence of individuals with chronic SCI are heavily influenced by various factors, including physical limitations, psychological well-being, and sleep quality. However, while much is known about the physiological impacts of SCI, there is a scarcity in studies that have explored how sleep affects both disability (the limitations imposed by the injury) and functional outcomes (the ability to perform activities of daily living, including mobility, self-care, and employment).
Sleep quality has been shown to affect cognitive functioning, physical endurance, mood, and pain levels—each of which plays a significant role in the ability of SCI individuals to perform daily tasks and participate in social and occupational activities. Poor sleep may exacerbate disability by increasing fatigue, reducing energy levels, and affecting mood regulation, all of which can contribute to functional limitations.
This study aims investigate the extent to which sleep quality impacts both disability and functional limitations in individuals with chronic SCI. By understanding these relationships, a better tailored individualized rehabilitation programs that address sleep disturbances as a modifiable factor can be made that may potentially improve the overall quality of life for individuals living with chronic SCI.
Methodology
Type of study: Prospective Cross-sectional Study.
Duration of Study: 2 years
Study Population: Patients of Chronic Spinal Cord Injury
Sample Size- For the purpose of sample size estimation, Avluk et al study was used. It was calculated using Online Openapi sample size calculator. To estimate the desired outcome in this study, significant with 95% confidence interval and power of 80%, the required minimum sample size will be 82 patients. Taking 10% non-valid responses, total sample size will be 91 patients of chronic spinal cord injury.
Inclusion Criteria: Must be a patient of chronic spinal cord injury irrespective of cause (time since injury > 6month). Age of patient must be more than 18 years.
Exclusion Criteria: Patient on a rehabilitation protocol from any other place or institute. Patients who do not want to take part in study. Pregnant females. Severe cognitive impairments (patients unable to comprehend or fill out questionnaires). History of psychiatric disorders unrelated to SCI (e.g., schizophrenia, bipolar disorder).
Sampling Technique: Consecutive sampling will be employed to select study participants from patients attending the Outpatient Department (OPD) of a tertiary care hospital. Individuals meeting the inclusion and exclusion criteria will be finally enrolled in the study after providing informed written consent.
Study Plan: Patient will be recruited from department of Physical Medicine and Rehabilitation OPD/IPD. Study will be started only after getting approval from Institutional Ethical Committee. Patients will be evaluated for inclusion and exclusion criteria. Written and informed consent will be taken from all participants. All the data will be recorded in working proforma Patients will be evaluated using 4 Scales/questionnaires: Pittsburgh Sleep Quality Index (PSQI) Hindi Version;World Health Organization Disability Assessment Schedule (WHODAS 2.0– 12 item Questionnaire); Functional Independence Measure (FIM), Patient Health Questionnaire-9 (PHQ-9), Pain (if any) will be assessed using Numeric Pain Rating Scale (NPRS).
Statistical Analysis
Descriptive statistics will be used to summarize the demographic and clinical characteristics of the study participants. The following analyses will be performed. Correlation Analysis: Pearson or Spearman correlation tests (depending on data distribution) will be used to examine the relationship between sleep quality (PSQI), WHODAS 2.0 12 item scale and FIM. Group Comparisons: Chi-Square test will be used to compare sleep quality between Groups based on Gender; Poor or Good Sleep Quality; Pain Levels Regression Analysis: Multiple linear regression will be used to determine the independent effects of pain, disability (WHODAS 2.0), and functional independence (FIM) on sleep quality (PSQI), adjusting for potential confounders such as age, injury level, and comorbidities.A p-value of <0.05 will be considered statistically significant. SPSS version 29 will be used for the statistical analysis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Must be a patient of chronic spinal cord injury irrespective of cause, time since injury should be more than six months.
- •Age of patient must be more than 18 years.
排除标准
- •Patient on a rehabilitation protocol from any other place or institute.
- •Patients who do not want to take part in study.
- •Pregnant females.
- •Severe cognitive impairments, patients unable to comprehend or fill out questionnaires.
- •History of psychiatric disorders unrelated to SCI.
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: One time through questionnaire since it is a cross sectional study
World Health Organization Disability Assessment Schedule (WHODAS 2.0 – 12 item Questionnaire
时间窗: One time through questionnaire since it is a cross sectional study
Functional Independence Measure
时间窗: One time through questionnaire since it is a cross sectional study
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(Numerical Pain rating Scale (NPRS))
研究者
SATYASHEEL SINGH ASTHANA
All India Institute of Medical Sciences, Raebareli
