Biopsy WoundNCT06171581
Effect of Stress Ball Use on Anxiety Level During Endometrial Biopsy Procedure
A study testing stress ball in people with Biopsy Wound and Endometrial Hyperplasia, run by Zonguldak Bulent Ecevit University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Biopsy Wound, Endometrial Hyperplasia, Endometrial Neoplasms
- What is being tested?
- stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
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
Read the 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.
- Conditions
- Biopsy Wound, Endometrial Hyperplasia, Endometrial Neoplasms
- Being tested
- stress ball, control
- Keywords
- stress ball, endometrial biopsy, women
- Medical subject headings
- Endometrial Hyperplasia, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ballOther
Also called experimental group- 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.
controlOther
Also called no intervention-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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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.
Measured: 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.
Measured: 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.
Measured: before and after the biopsy (1-2 minutes before and 1-2 minutes after biopsy procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study startFeb 2024 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biopsy WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized control study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz DİNÇER, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171581
- Sponsor's protocol ID
- 'ZonguldakBEU'
- Status last verified
- Dec 2023
- First submitted
- 25 Oct 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study is planned to be completed within 1 year and published as a publication within 3 years.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stress Ball Use on Anxiety Level During Endometrial Biopsy Procedure
- ClinicalTrials.gov ID
- NCT06171581
- Acronym / sponsor ID
- 'ZonguldakBEU'
- Conditions
- Biopsy Wound, Endometrial Hyperplasia, Endometrial Neoplasms
- Keywords
- stress ball, endometrial biopsy, women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A randomized control study
| Arm | Type | Receives |
|---|---|---|
| experimental-stress ball | Experimental | Other: stress ballThe study is planned to consist of two groups as experimental and control. No intervention will be given to the control group. |
| no intervention- none | Experimental | Other: controlThe study is planned to consist of two groups as experimental and control. No intervention will be given to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress ballAlso: experimental group- stress ballIn 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 | experimental-stress ball |
| controlAlso: no intervention-controlIn 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 | no intervention- none |
Primary outcome
"State and Trait Anxiety Scale"
Time frame: before and after the biopsy procedure(1-2 minutes before and 1-2 minutes after biopsy procedure)
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.
"Visual Analogue Scale (VAS)" ( min 0- max 10)
Time frame: before and after the biopsy (1-2 minutes before and 1-2 minutes after biopsy procedure)
It constitutes another parameter for measuring the stress level.
blood pressure ( systolic and diastolic) mm/ hg
Time frame: before and after the biopsy (1-2 minutes before and 1-2 minutes after biopsy procedure)
The aim is to determine the changes caused by stress on blood pressure before and after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Yes. The study is planned to be completed within 1 year and published as a publication within 3 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing stress ball in people with Biopsy Wound and Endometrial Hyperplasia, run by Zonguldak Bulent Ecevit University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"State and Trait Anxiety Scale" (time frame: before and after the biopsy procedure(1-2 minutes before and 1-2 minutes after biopsy procedure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.