Clinical trial NCT06171581: Effect of Stress Ball Use on Anxiety Level During Endometrial Biopsy Procedure
Official title: Effect of Stress Ball Use on Anxiety Level During Endometrial Biopsy Procedure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Biopsy Wound
Endometrial Hyperplasia
Endometrial Neoplasms
Keywords: stress ball
endometrial biopsy
women
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized control study
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: "State and Trait Anxiety Scale"
timeFrame: before and after the biopsy procedure(1-2 minutes before and 1-2 minutes after biopsy procedure)
measure: "Visual Analogue Scale (VAS)" ( min 0- max 10)
timeFrame: before and after the biopsy (1-2 minutes before and 1-2 minutes after biopsy procedure)
measure: blood pressure ( systolic and diastolic) mm/ hg
timeFrame: before and after the biopsy (1-2 minutes before and 1-2 minutes after biopsy procedure)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: