Associate Professor Registered Nurse Doctor of Philosophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI).
研究概览
简要总结
Objective: This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.
Patients and methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory.
详细描述
Objective
This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.
Background: Sleep problems, pain, and depression are common health issues in individuals with fibromyalgia. However, studies on sleep hygiene education to address these problems are limited in the literature.
Methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •The inclusion criteria for the study were as follows:
- •Being 18 years of age or older,
- •Having a diagnosis of Fibromyalgia (FM) for at least 3 months,
- •Being reachable,
- •Agreeing to participate in the study,
- •Not receiving treatment for depression,
- •Not having received similar education on sleep hygiene,
- •Having a VAS pain score >3,
- •Having a PSQI score >5.
排除标准
- •Additionally, the exclusion criteria for the study were as follows:
- •Having a diagnosis of FM for less than 3 months,
- •Using sleep medication,
- •Having chronic illnesses that could interfere with sleep such as Chronic Obstructive Pulmonary Disease (COPD) or asthma,
- •Working on night shifts.
研究组 & 干预措施
Control group
The DIF, PSQI, VAS, and BDI were also administered to individuals in the control group during the first interview, but no education was provided to them. The participants were given an appointment to meet at the hospital one month later. At the final polyclinic appointment one month later, the VAS, PSQI, and BDI were administered for the second time and took an average of 15-20 minutes to complete. In line with ethical principles, they were provided with individual education on sleep hygiene and sleep hygiene education booklets at the final polyclinic appointment. The same researcher collected the data and provided the education to avoid bias.
Experimental group
During the first interview, the DIF, PSQI, VAS, and BDI were administered to individuals in the experimental group. Each education session lasted an average of 30 minutes and was conducted face-to-face. Sleep hygiene education booklets were provided to individuals at the end of the education session. Studies suggest that at least one month should pass for behavioral change to occur after the education session. Therefore, the participants were given an appointment to meet at the hospital one month later. At the final interview one month after the education, the VAS, PSQI, and BDI were administered for the second and final time and took an average of 15-20 minutes to complete.
干预措施: Sleep hygiene education (Other)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI).
时间窗: 1 month
The PSQI evaluates the quality of sleep in the last month. It consists of 19 items and 7 components. Each item is evaluated on a 0-3 point scale, and the sum of scores from seven components gives the total PSQI score. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. A total PSQI score of ≤5 indicates "good sleep," while a score of \>5 indicates "poor sleep." The Cronbach's alpha value of the scale is 0.80. In this study, the Cronbach's alpha was found to be 0.83.
Beck Depression Inventory (BDI).
时间窗: 1 month
The scale consists of a total of 21 items. The highest possible total score is 63. A high total score indicates a higher level of depression. The severity of depression is categorized as follows: 0-9 = minimal, 10-16 = mild, 17-29 = moderate, and 30-63 = severe depression. The internal consistency coefficient of the scale is 0.86. In this study, the Cronbach's alpha was found to be 0.83.
Demographic Information Form (DIF).
时间窗: 1 month
This form was prepared by the researcher based on the literature and consists of 10 questions about the FM patients' sociodemographic and disease characteristics (age, gender, educational status, etc.).
Visual Analog Scale (VAS).
时间窗: 1 month
The VAS is a valid and reliable scale to measure the intensity of chronic pain. It is rated from "0 = no pain" to "10 = worst possible pain". The intervals for pain intensity are \<3 for mild pain, 3-6 for moderate pain, and \>6 for severe pain. The Cronbach's alpha value of the scale is 0.97. In this study, the Cronbach's alpha was found to be 0.92.
次要结局
未报告次要终点
研究者
Tülay Kars Fertelli
Assoc. Prof
Cumhuriyet University