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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Endometrial Hyperplasia; Endometrial Neoplasms; Biopsy Wound
• Intervention / Treatment: Other: stress ball; Other: control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental-stress ball; 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; 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.; Other Names: experimental group- stress ball
Experimental: no intervention- none; The study is planned to consist of two groups as experimental and control. No intervention will be given to the control group.	Other: control; 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.; Other Names: no intervention-control

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Zonguldak Bulent Ecevit University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: women; endometrial biopsy; stress ball
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Hyperplasia; Endometrial Hyperplasia; Endometrial Neoplasms
• Other Study ID Numbers: 'ZonguldakBEU'

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study is planned to be completed within 1 year and published as a publication within 3 years.
• IPD Sharing Time Frame: It is planned to be published within 3 years
• IPD Sharing Access Criteria: The study is planned to be published openly.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No