The Effect of Using a Stress Ball on Pain, Anxiety and Satisfaction During the Endoscopy Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change on pain intensity as measured by Visual Analog Scale
研究概览
简要总结
Endoscopy procedure is a frequently used method in the evaluation of the gastrointestinal system. Upper gastrointestinal system endoscopy can be performed with and without sedation. Sedation is the controlled sleep of the patient with certain drugs (pharmacological methods). Non-pharmacological methods help reduce anxiety and pain. In this study, a non-pharmacological stress ball will be used. It is aimed to evaluate the effect of using a stress ball on pain, anxiety and satisfaction during upper gastrointestinal system endoscopy.
详细描述
Patients do not want to think that an upper GIS endoscopy without sedation will be difficult. However, some complications can be seen like hypoxemia, allergic reaction, malignant hyperthermia, hypoventilation, respiratory depression, hypotension, bradycardia, apnea, hypoxia, etc. due to sedation applied during endoscopy.
Non-pharmacological methods help reduce anxiety and pain. Although sedative and analgesic medications reduce anxiety and relieve pain, endoscopy is still painful for patients. During the endoscopy process, non-pharmacological methods are used to draw attention to another direction, but it is not encountered that the stress ball is used as one of these methods in the endoscopy procedure.
This study was planned as a single-center prospective randomized controlled study for the treatment of the stress ball method used during the endoscopy procedure, pain in anxiety and satisfaction levels.
The data obtained in the study will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Number, percentage, mean, standard deviation will be used as descriptive statistical methods in the evaluation of data. In comparing the difference between two independent groups, Student's t test will be used for data conforming to normal distribution, and Mann-Whitney U test will be used for data that do not comply with normal distribution. The difference between two repeated measurements will be analyzed with dependent groups t-test for data conforming to normal distribution, and Wilcoxon test for data that do not conform to normal distribution. The difference between three and more measurements that do not comply with the normal distribution will be compared with the analysis of variance in repeated measures for data that do not fit the normal distribution, and with the Friedman test for data that do not comply with the normal distribution. A value of P <0.05 will be considered as statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- 是
入选标准
- •To have an upper gastrointestinal endoscopy for the first time
- •Not wanting sedation during upper gastrointestinal endoscopy
- •Being between the ages of 18-75
- •Being willing to participate in research
排除标准
- •Using analgesic or anesthetic drugs before or during the procedure
- •Using antidepressants, anxiolytic and sedative drugs
- •Having communication difficulties and mental disability
结局指标
主要结局
Change on pain intensity as measured by Visual Analog Scale
时间窗: just before procedure, during, and just after procedure
The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.
次要结局
- Score change on anxiety level as measured by State-Trait Anxiety Inventory(just before and after procedure)
研究者
Elif Gezginci
Rn, PhD, Asst Prof.
Saglik Bilimleri Universitesi