Translation and Psychometric Properties of the Fatigue Severity Scale in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale
研究概览
简要总结
The study will employ a Cross-Sectional Validation Study design. The study will be conducted at the Department of Physical Therapy, University of Lahore Teaching Hospital, located on Defence Road, Lahore.
The anticipated duration of the study will be 09 months, commencing after the approval of the synopsis.
The sample size will be determined following the Kline Method, resulting in a total of 90 participants.
A Purposive Sampling Technique will be utilized to select the study participants.
详细描述
Study Type: Cross-Sectional Validation Study Location: Department of Physical Therapy, University of Lahore Teaching Hospital, Defence Road, Lahore Duration: 06 months (post-synopsis approval) Sample Size: 90 participants Sampling Technique: Purposive Sampling Consent and Ethics: Participants will provide written informed consent. Ethics approval will be obtained from the University of Lahore Ethics Committee.
Translation of FSS:
The Fatigue Severity Scale (FSS) will be translated into Urdu for data collection.
Two independent bilingual translators will create reports on translation difficulties and rationale.
These reports will inform a consensus meeting to develop a unified Urdu version, with comments documented.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Both genders with age of 18 years and above
- •Diagnosed and referred patients of fibromyalgia according to the American College of Rheumatology (ACR) criteria.
- •The ability to provide informed consent and wiling to participate in the study.
- •Fluency in the study language (i.e. Urdu in this case).
排除标准
- •Any other chronic pain condition that could affect fatigue and sleep.
- •Diagnosed sleep disorder (such as sleep apnea or insomnia) that could affect the results.
- •History of a psychiatric disorder that could affect the results.
- •History of substance abuse.
- •Participation in any other study that could affect the results at the time of recruitment.
结局指标
主要结局
Fatigue Severity Scale
时间窗: 1 week
The Fatigue Severity Scale (FSS) is a self-reported measure of fatigue and sleep disturbance in patients with fibromyalgia. It is a 9-item scale that assesses the severity of fatigue, the impact of fatigue on daily activities, and the degree of sleep disturbance. The FSS is a widely used instrument in research and clinical practice, and has been found to be a valid and reliable measure of fatigue and sleep disturbance in patients with fibromyalgia. The FSS items are rated on a 5-point Likert scale, with responses ranging from "not at all" to "extremely." The total score ranges from 0 to 36, with higher scores indicating greater levels of fatigue and sleep disturbance.
Multidimensional Fatigue Inventory
时间窗: 1 week
The Multidimensional Fatigue Inventory (MFI) is a self-report questionnaire designed to assess various dimensions of fatigue experienced by individuals. It is commonly used in research and clinical settings to measure and understand fatigue in different contexts. Respondents answer a series of questions related to each dimension on a Likert-type scale, typically ranging from 1 to 5 or 0 to 4. The scores from each dimension are summed to obtain subscale scores, and a total score is often calculated by summing all subscale scores. Higher scores indicate greater levels of fatigue.
次要结局
未报告次要终点
