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临床试验/NCT06460974
NCT06460974尚未招募不适用

The Effect of Stress Ball Application on Stress, Anxiety and Comfort During Chemotherapy in Women With Breast Cancer: A Randomized Controlled Study

Mersin University2 个研究点 分布在 2 个国家目标入组 74 人开始时间: 2024年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
74
试验地点
2
主要终点
General Comfort Scale

研究概览

简要总结

This research was conducted as a randomized controlled study to determine the effect of stress ball application on stress, anxiety and comfort in women with breast cancer receiving chemotherapy.

详细描述

The research was conducted as a randomized controlled study. A total of 74 patients were randomly assigned to the stress ball group (n=37) and the control group (n=37).

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • who is literate in Turkish,
  • who was diagnosed with stage 1, 2 and 3 breast cancer
  • who had the second cure or above chemotherapy receiving treatment
  • over 18 years of age
  • platelet level >50,000 mm3
  • not having any physical problems squeezing a stress ball

排除标准

  • those who did not agree to participate in the study
  • those who received chemotherapy for the first time,
  • those who had any physical disability to squeeze a stress ball
  • Any receiving intravenous treatment from both arms,
  • having had a unilateral or bilateral mastectomy and having a problem squeezing a stress ball,
  • having any psychiatric disease,

结局指标

主要结局

General Comfort Scale

时间窗: 6 months

The scale contains a total of 48 items in a four-point Likert type and consists of four sub-dimensions (physical, psycho-spiritual, environmental, and socio-cultural sub-dimensions).

Distress Thermometer

时间窗: 6 months

Distress level is determined by a visual analog scale ranging from "0-10". Patients express the psychological distress they feel with the numbers on the thermometer; "0 points" means that the patient does not experience any distress, and "10 points" means that the patient experiences the highest level of distress

State-Trait Anxiety Inventory

时间窗: 6 months

It evaluates the state of anxiety felt by the individual due to the stressful situation he is in. The first 20 items, consisting of short statements, measure the individual's state anxiety level.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Birgul Vural Dogru

Associate Professor

Mersin University

研究点 (2)

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