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临床试验/NCT06977867
NCT06977867Enrolling By Invitation不适用

The Effect of Stress Ball Use on Comfort, Anxiety, and Patient Satisfaction in Hemodialysis Patients

Bitlis Eren University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
36
试验地点
1
主要终点
Level of anxiety

研究概览

简要总结

Chronic kidney disease represents a significant public health issue both in Türkiye and worldwide, with the majority of patients undergoing hemodialysis treatment. Individuals receiving hemodialysis often experience not only physical discomfort but also psychological distress, including heightened anxiety and reduced comfort. The aim of this study is to evaluate the effects of stress ball use on comfort, anxiety, and patient satisfaction among hemodialysis patients. The stress ball is a simple and cost-effective non-pharmacological intervention that aids individuals in managing stress by redirecting their attention. Notably, this study is unique in simultaneously investigating comfort, anxiety, and satisfaction parameters within this patient population.

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 98 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Being 18 years of age or older
  • •Being literate
  • •Having no visual or hearing impairments
  • •Being able to communicate verbally
  • •Having no physical disability that would prevent the use of a stress ball
  • •Not having a diagnosed anxiety disorder and not using medication for it
  • •Willingness to participate in the study

排除标准

  • •Currently using sedative medications
  • •Having a diagnosed psychiatric disorder
  • •Having any physical limitation that prevents squeezing a stress ball

研究组 & 干预措施

Stress Ball

Experimental

All hemodialysis patients who meet the inclusion criteria will be asked to squeeze a stress ball during their dialysis sessions (3 times a week for 1 month, totaling 12 sessions). Anxiety, comfort, and patient satisfaction levels will be assessed using three measurements: a pre-test before the intervention, a mid-test at the end of the 6th session (2nd week), and a post-test after the 12th session. Patients will be instructed to use the stress ball throughout their dialysis session. They will be asked to squeeze the ball for at least 10-15 minutes during each session.

干预措施: Stress Ball (Device)

Control

Other

The hemodialysis patients in the control group will not use the stress ball and will receive standard care throughout the study period. Similar to the intervention group, levels of anxiety, comfort, and patient satisfaction will be assessed at three time points: prior to the intervention (pre-test), at the end of the second week (after the 6th session), and at the end of the fourth week (post-test, after the 12th session).

干预措施: standard care (Other)

结局指标

主要结局

Level of anxiety

时间窗: 1 month

The anxiety levels of patients included in the study will be assessed prior to the intervention using the Visual Analog Scale (VAS). The VAS scores will be categorized as follows: low anxiety (0-3), moderate anxiety (4-6), and high anxiety (7-10).

Patient's comfort

时间窗: 1 month

The comfort levels of patients using the stress ball during the hemodialysis procedure will be assessed using the Hemodialysis Comfort Scale. The minimum score obtainable from the scale (20) indicates low comfort, while the maximum score (100) reflects high comfort.

Level of patient satisfaction

时间窗: 1 month

Patient satisfaction during the hemodialysis procedure among those using the stress ball will be assessed using the Visual Analog Patient Satisfaction Scale. VAS scores will be categorized as follows: low satisfaction (0-3), moderate satisfaction (4-6), and high satisfaction (7-10).

次要结局

未报告次要终点

研究者

发起方
Bitlis Eren University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hasret Topalı

Lecturer

Bitlis Eren University

研究点 (1)

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