The Effect of Stress Ball Use on Stress, Sleep Quality, and Comfort Levels in Hemodialysis Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Stress evaluated using the Perceived Stress Scale
研究概览
简要总结
This study was conducted to determine the impact of stress ball use on stress, sleep quality, and comfort levels in hemodialysis patients.
详细描述
The study population consisted of patients undergoing hemodialysis treatment in the hemodialysis unit of a training and research hospital located in western Türkiye between February 19, 2024, and April 19, 2024 (N=90). The study sample included a total of 60 patients (30 in the experimental group and 30 in the control group), selected through randomization from those who met the research criteria and agreed to participate. During the study, two patients from the experimental group and one patient from the control group were excluded from the study due to health issues that prevented them from using the stress ball. The study was conducted with a total of 57 patients (28 in the experimental group and 29 in the control group).
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patients involved in the study, the researcher collecting the pre-test and post-test data, and the statistician evaluating the data were not informed about the group assignments.
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
- •participants had to be volunteers
- •aged 18 years and older,
- •undergoing hemodialysis treatment for at least six months,
- •attending hemodialysis sessions three times a week,
- •not having any conditions that would impede the use of a stress ball.
排除标准
- •individuals who refused to participate in the study,
- •those undergoing hemodialysis for less than six months,
- •patients attending hemodialysis sessions twice a week,
- •individuals with health problems that prevented them from using a stress ball.
研究组 & 干预措施
stress ball
the stress ball intervention was initiated. Before starting, the researcher provided instructions and demonstrations on how to use the stress ball, allowing then the patients to practice. The stress ball intervention was administered during the second hour of the hemodialysis session when patients were most comfortable. Patients were instructed to squeeze the stress ball once, counting internally as "1-2-3" with each squeeze. The stress ball intervention was administered three times weekly during hemodialysis sessions for 15 minutes each session, totaling 12 sessions for a period of four weeks. Throughout the intervention, patients were observed by the same researcher.
干预措施: stress ball (Other)
Control
No intervention will be made to the contro group, only data will be collected at the same time as the study group.
结局指标
主要结局
Stress evaluated using the Perceived Stress Scale
时间窗: Change from before implementation and 4th week of practice
The obtainable total score from the scale ranges from 0 to 56, with higher scores indicating a greater perception of stress
Sleep quality ewaluated the Pittsburgh Sleep Quality Index
时间窗: Change from before implementation and 4th week of practice
The sum of the scores from these seven components yields the total PSQI score, which ranges from 0 to 21. Individuals with a total score of 5 or lower are classified as having 'good" sleep quality, while those with a score above 5 are classified as having "poor" sleep quality.
Comfort evaluated using Hemodialysis Comfort Scale Version II
时间窗: Change from before implementation and 4th week of practice
The total score obtained from the scale ranges from 26 to 130, with higher scores indicating greater comfort levels.
次要结局
未报告次要终点
研究者
Ayse Vicdan
Associate professor
Muğla Sıtkı Koçman University