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

Endometrial Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06171581
• Other study ID #: 'ZonguldakBEU'
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: March 2024

Study information

• Verified date: December 2023
• Source: Zonguldak Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: March 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biopsy Wound
• Endometrial Hyperplasia
• Endometrial Neoplasms
• Hyperplasia

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zonguldak Bulent Ecevit University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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)
Primary	"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)
Primary	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)