Effect of Stress Ball Applied Before Cholecystectomy Surgery on Surgical Fear, Anxiety and Comfort of Patients: A Randomized Controlled Trial
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
- Stress
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
- 是
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
研究组 & 干预措施
Intervention
The researcher obtained 6 cm-diameter, moderate hardness, compressible balls made of silicone material in similar colors, mainly blue and green tones, some of which combined both colors featuring an Earth motif, before the study.
干预措施: Stress Ball (Other)
Control group
Patients included in the control group had no intervention performed after completing the scale tools on the pretest, and 30 minutes later, the Surgical Fear Questionnaire, VAS-A and General Comfort Questionnaire were administered (posttest). Patients in the control group were not given stress balls for the pretest or posttest. No intervention was applied to patients in the control group. The scales were completed by researchers via face-to-face interviews in the preoperative waiting unit.
结局指标
主要结局
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".
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.
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
Fear of surgery
时间窗: 30 minutes before surgery
The scale consists of 8 items and is an 11-point Likert type, with each item scored between 0 (I am not afraid at all) and 10 (I am very afraid). bottom of scale The lowest score that can be obtained from the dimensions is 0, the highest score is 40, the lowest score that can be obtained from the total scale is 0 and the highest score is 80.
Comfort
时间窗: 30 minutes 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: 30 minutes 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
Seda Cansu Yeniğün
Principal Investigator
Akdeniz University