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

NCT06171581 | Unknown

• 1 other identifier: 'ZonguldakBEU'
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Biopsy Wound; Endometrial Hyperplasia; Endometrial Neoplasms

Keywords

stress ball; endometrial biopsy; women

Outcome Measures

Primary Outcomes (3)

• "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)

Study Arms (2)

experimental-stress ball

EXPERIMENTAL

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

no intervention- none

EXPERIMENTAL

The study is planned to consist of two groups as experimental and control. No intervention will be given to the control group.

Other: control

Interventions

stress ball OTHER

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.

Also known as: experimental group- stress ball

experimental-stress ball

control OTHER

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.

Also known as: no intervention-control

no intervention- none

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• EXPERIMENT GROUP
• Willingness to participate in the research
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

MeSH Terms

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Principle İnvestigator

Model Details: A randomized control study

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: December 14, 2023
• Study Start: February 1, 2024
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: It is planned to be published within 3 years
• Access Criteria: The study is planned to be published openly.