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临床试验/NCT05533398
NCT05533398已完成不适用

Effect of Stress Ball Use on Anxiety in Haemodialysis Patients: A Single-blind Randomized Controlled Crossover Study

Istanbul Demiroglu Bilim University2 个研究点 分布在 2 个国家目标入组 65 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
2
主要终点
Change From Baseline Depression Level at 12 Dialysis Session

研究概览

简要总结

Stress management in dialysis patients plays a key role in reducing these negativities and in maintaining both physical and mental well-being. In dialysis patients, on the other hand, the effectiveness of stress ball use on comfort and stress was evaluated, and no study was found that evaluated its effect on anxiety.

详细描述

Stress ball is one of the non-pharmacological methods used to distract individuals when they consciously focus on a stimulus. With the squeezing of the ball, the nerves in the hands are stimulated and stimuli are sent to the limbic region of the brain, and these stimuli provide an acupressure effect. At the same time, it is the easiest and cheapest method that allows the mind to get away from stress and maintain the mental well-being of the person.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • On maintenance hemodialysis three times per week for four hours per session
  • Able to communicate in Turkish
  • Willing to participate to the study

排除标准

  • Having any health problems related to the hand/arm to use the stress ball
  • Patients who did not want to participate in the study

结局指标

主要结局

Change From Baseline Depression Level at 12 Dialysis Session

时间窗: Up to 2 months

It will be assessed two times with Hospital Anxiety and Depression Scale (HADS). Seven of the 14 questions measure anxiety and seven measure depression. Responses are scored in a four-point Likert format between 0-3. The lowest score that patients can get from both subscales is 0, and the highest score is 21. The cut-off points of the Turkish version of HADS were determined as 10 for the anxiety subscale and 7 for the depression subscale.

Change From Baseline Anxiety Level at 12 Dialysis Session

时间窗: Up to 2 months

It will be assessed two times with Hospital Anxiety and Depression Scale (HADS). Seven of the 14 questions measure anxiety and seven measure depression. Responses are scored in a four-point Likert format between 0-3. The lowest score that patients can get from both subscales is 0, and the highest score is 21. The cut-off points of the Turkish version of HADS were determined as 10 for the anxiety subscale and 7 for the depression subscale.

次要结局

未报告次要终点

研究者

发起方
Istanbul Demiroglu Bilim University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurten Ozen

Associate Professor

Istanbul Demiroglu Bilim University

研究点 (2)

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