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临床试验/NCT06345768
NCT06345768已完成不适用

Effect of Stress Ball Applied Before Cholecystectomy Surgery on Surgical Fear, Anxiety and Comfort of Patients: A Randomized Controlled Trial

Akdeniz University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Fear of surgery

研究概览

简要总结

Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery.

Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. It is seen that the stress ball method is used to reduce patients' anxiety and pain. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing their sense of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure.

In this study, it is aimed to evaluate the effect of preoperative use of stress ball on patients' fear, stress and comfort in order to determine the effect of stress ball applied before cholecystectomy surgery on patients' surgical fear, stress and comfort. It is thought that the data obtained as a result of the research will provide evidence for the effect of the stress ball, which is a non-pharmacological method used before the procedure, on fear, stress and comfort.

详细描述

This study was planned to examine the effect of a stress ball applied to patients before laparoscopic cholecystectomy on preoperative anxiety, surgical fear and comfort. Patients were given a stress ball before the procedure, and the other group received routine care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Age 18 years or older
  • Able to speak and understand Turkish
  • Being literate
  • Patients who underwent elective laparoscopic cholecystectomy
  • Volunteering to participate in the study

排除标准

  • Use of any analgesic or anxiolytic preoperatively
  • Any physical obstacle to using a stress ball (patients with partial paralysis or weak hand muscles)
  • History of psychiatric disorders or ongoing psychiatric treatment.
  • Emergency surgery
  • Open cholecystectomy
  • Hearing or perception problems

结局指标

主要结局

Fear of surgery

时间窗: Just before surgery

The scale consists of 8 items and is an 11-point Likert type, with each item scored

Comfort

时间窗: Just before surgery

The scale contains a total of 48 items in four/six point Likert type; Four-point Likert type was preferred due to its ease of use. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48.

Stress

时间窗: Just before surgery

It was designed by researchers similar to the use of "Visual Analog Scale (VAS)". VAS is used to make measurable some values that cannot be measured numerically, which are evaluated by individuals by marking on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end indicates that the individual is "very bad".

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

Seda Cansu Yeniğün

Principal Investigator

Akdeniz University

研究点 (1)

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