Effect of Stress Ball Use on Anxiety Level During Endometrial Biopsy Procedure (NCT06171581) | Clinical Trial Compass
UnknownNot Applicable
Effect of Stress Ball Use on Anxiety Level During Endometrial Biopsy Procedure
70 participantsStarted 2024-02
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
"State and Trait Anxiety Scale"
Timeframe: before and after the biopsy procedure(1-2 minutes before and 1-2 minutes after biopsy procedure)
2
"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)
3
blood pressure ( systolic and diastolic) mm/ hg
Timeframe: before and after the biopsy (1-2 minutes before and 1-2 minutes after biopsy procedure)