Effect of Stress Ball Use on Anxiety Level During Endometrial Biopsy Procedure

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effect of Stress Ball Use on Anxiety Level During Endometrial Biopsy Procedure

Conditions
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Biopsy Wound, Endometrial Hyperplasia, Endometrial Neoplasms

Intervention / Treatment
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* Other: stress ball
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized control study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental-stress ball<br>The study is planned to consist of two groups as experimental and control. No intervention will be given to the control group. | Other: stress ball<br>* In the study, the experimental group was given a round, compressible ball for stress ball application and it was planned to squeeze this ball in their hands as often as they wanted during anaesthesia and endometrial biopsy application. The endometrial biopsy procedure is a procedure that usually takes between 8-10 minutes. The results will be evaluated considering these average times. As it is foreseen that individuals may experience the most intense anxiety and stress during anaesthesia and biopsy, it was preferred to cover this time period.<br>* Other names: experimental group- stress ball;|
| Experimental: no intervention- none<br>The study is planned to consist of two groups as experimental and control. No intervention will be given to the control group. | Other: control<br>* In the study, the no intervention group ( control group) will receive no intervention and blood pressure and stress measurements will be made with routine care and nursing interventions.<br>* Other names: no intervention-control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State and Trait Anxiety Scale | 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. | before and after the biopsy procedure(1-2 minutes before and 1-2 minutes after biopsy procedure) | 
| Visual Analogue Scale (VAS) ( min 0- max 10) | It constitutes another parameter for measuring the stress level. | before and after the biopsy (1-2 minutes before and 1-2 minutes after biopsy procedure) | 
| blood pressure ( systolic and diastolic) mm/ hg | The aim is to determine the changes caused by stress on blood pressure before and after the procedure. | before and after the biopsy (1-2 minutes before and 1-2 minutes after biopsy procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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women, stress ball, endometrial biopsy