Effect of Stress Ball Use on Anxiety Level During Endometrial Biopsy Procedure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- "Visual Analogue Scale (VAS)" ( min 0- max 10)
研究概览
简要总结
The aim of this study is to determine the effect of stress ball application on the anxiety level during the endometrial biopsy procedure.
This research is planned as a randomised controlled study. Place and time of the research: The research is planned with patients who will undergo endometrial biopsy procedure in Zonguldak Obstetrics and Gynecology Hospital affiliated to the Ministry of Health.
While there are various experimental studies in the literature on the effect of stress ball on anxiety during many painful procedures, there is no study in the literature on the effect of stress ball on anxiety level during endometrial biopsy procedure (Akarsu, Kuş & Akarsu 2021, Genç 2021Nurdina, Anggraini & Novyanda 2022, Srivarsan, Sridevi & Preetha 2021, Yanks et al. 2018,) In this study, it was aimed to evaluate the effect of stress ball application on anxiety level during endometrial biopsy procedure
详细描述
Endometrial biopsy is a simple, inexpensive and effective method to rule out endometrial cancer.
Endometrial biopsy is the gold standard method in the diagnosis of endometrial pathologies and is widely used in gynaecological practice. Although endometrial biopsy is a common gynaecological procedure, its psychological effects have not been emphasised. In particular, the potential stress before and during the procedure, exposure to the test and the waiting time for the biopsy result have been mostly ignored. Patients with bleeding in the postmenopausal period already present to the physician with anxiety, and when it is stated that a biopsy should be taken for diagnosis, their anxiety increases due to both the procedure itself and the possibility of an unfavourable outcome at the end of the procedure.
While there are various experimental studies in the literature on the effect of stress ball on anxiety during many painful procedures, there is no study in the literature on the effect of stress ball on anxiety level during endometrial biopsy procedure .In this study, it was aimed to evaluate the effect of stress ball application on anxiety level during endometrial biopsy procedure.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •EXPERIMENT GROUP
- •Willingness to participate in the research
- •18 years of age or older
- •Reading and writing Turkish
- •No active mental illness preventing data collection
- •No impediment to squeezing the ball
- •No emergency and risky situation that will prevent data collection during the process CONTROL GROUP
- •Willingness to participate in the research
- •18 years of age or older
- •Reading and writing Turkish
- •No active mental illness preventing data collection
- •No emergency and risky situation that will prevent data collection during the process
排除标准
- •INTERVENTION GROUP
- •Not willing to participate in the research
- •Under 18 years of age
- •Not knowing how to read and write Turkish
- •Having an active mental illness that prevents data collection
- •Having an obstacle to squeezing the ball
- •The development of an urgent and risky situation that will prevent data collection during the process CONTROL GROUP
- •Not willing to participate in the research
- •Under 18 years of age
- •Not knowing how to read and write Turkish
- •Having an active mental illness that prevents data collection
- •The development of an urgent and risky situation that will prevent data collection during the process
结局指标
主要结局
"Visual Analogue Scale (VAS)" ( min 0- max 10)
时间窗: before and after the biopsy (1-2 minutes before and 1-2 minutes after biopsy procedure)
It constitutes another parameter for measuring the stress level.
"State and Trait Anxiety Scale"
时间窗: before and after the biopsy procedure(1-2 minutes before and 1-2 minutes after biopsy procedure)
The state and trait anxiety scale consists of two parts and contains a total of 40 questions. The first 20 questions of the scale measure state anxiety, and the last 20 questions measure trait anxiety. The results of the state anxiety section of the scale will be used in this research. The State Anxiety Scale requires the individual to describe how he or she feels at a particular moment and under certain circumstances.
blood pressure ( systolic and diastolic) mm/ hg
时间窗: before and after the biopsy (1-2 minutes before and 1-2 minutes after biopsy procedure)
The aim is to determine the changes caused by stress on blood pressure before and after the procedure.
次要结局
未报告次要终点
研究者
Yeliz DİNÇER
Dr, Principle İnvestigator
Zonguldak Bulent Ecevit University