StressStress ballNCT07507617
The Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables
A study testing Stress ball in people with Stress, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stress
- What is being tested?
- Stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2026to 9 Oct 2026
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older,
- Conscious and cooperative,
- Able to speak and understand Turkish,
- With stable general condition and hemodynamic variables,
- Scheduled for the procedure,
- Without any psychiatric diagnosis,
- Not using psychiatric and/or local neuromuscular blocking medications,
- Willing to participate in the study (having signed the Informed Consent Form).
Who cannot join
- Under 18 years of age,
- Not conscious or not cooperative,
- Unable to speak or understand Turkish,
- With unstable general condition or hemodynamic variables,
- Undergoing emergency surgical procedures,
- Having a current psychiatric diagnosis,
- Using psychiatric and/or local neuromuscular blocking medications,
- Unwilling to participate in the study (not signing the Informed Consent Form).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkey, Mersin University,
Yenişehir, Mersin, 33343
About this study
Official title: The Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables: A Randomized Controlled Trial
The Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables
Read the detailed description
Transrectal ultrasound (TRUS)-guided prostate biopsy is a standard and widely used invasive procedure in the diagnosis of prostate cancer. Tissue sampling is considered the gold standard for the early detection of prostate cancer, and TRUS-guided biopsy is the most commonly used method. As an invasive procedure performed under local anesthesia, it may lead to significant levels of anxiety and pain in patients. In particular, uncertainty prior to the procedure, fear of receiving a cancer diagnosis, and the transrectal route of intervention are among the main factors that increase the psychological burden. Consequently, changes in hemodynamic variables (such as heart rate and blood pressure) may also be observed.
The psychological stress experienced during this minimally invasive procedure may increase patients' perception of pain and negatively affect their tolerance. Increased levels of pain and anxiety may cause patients to move during the procedure, reduce cooperation, and prolong the duration of the procedure. Additionally, this situation may result in decreased patient comfort.
In the literature, both pharmacological and non-pharmacological methods have been identified to reduce pain and anxiety during prostate biopsy. Although pharmacological methods are effective, factors such as the risk of side effects, the need for sedation, and increased costs have led to a growing emphasis on non-pharmacological approaches in recent years. These approaches are attention-diverting, safe, and easy to implement. Non-pharmacological methods are among the core components of nursing care and support a patient-centered care approach. A meta-analysis conducted by He et al. found that music, one of the non-pharmacological methods, reduces pain and anxiety in patients undergoing prostate biopsy.
Another simple method that can be applied to patients is the use of a stress ball. The stress ball application, which allows patients to squeeze an object during procedures such as biopsy and helps divert their attention away from the procedure, is a simple and easily applicable non-pharmacological method aimed at reducing anxiety and pain perception. The mechanism of action of stress balls is based on suppressing the stress response through distraction, muscle relaxation, and enhancing the sense of control. It has been reported that stress balls reduce anxiety and pain levels during surgical and various interventional procedures, and also have positive effects on hemodynamic parameters such as heart rate and blood pressure. Randomized controlled studies conducted in different clinical settings, such as cataract surgery, endoscopy, angiography, and hemodialysis, have demonstrated that stress ball use increases patient comfort and reduces physiological stress responses. Additionally, in a study examining virtual reality and stress ball use during transrectal prostate biopsy, it was found that pain levels decreased 15 minutes after the procedure in the stress ball group compared to the control group (p < 0.05).
In the literature, there is no randomized controlled trial evaluating solely the effect of stress ball application on anxiety, pain, and hemodynamic parameters during TRUS-guided prostate biopsy. This highlights the need for further research to increase the level of evidence on this topic. Therefore, this study aims to evaluate the effect of stress ball use during TRUS-guided prostate biopsy on patients' anxiety and pain levels, as well as on hemodynamic variables.
- Conditions
- Stress
- Being tested
- Stress ball
- Keywords
- Biopsy, Pain, Stress, Stress ball
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ballOther
The stress ball intervention will be performed during the biopsy procedure for an average duration of 10 minutes. A round, medium-firm silicone ball with an approximate diameter of 6 cm, made of high-quality materials, will be used in the application. Patients will be instructed to place the ball in the palm of their hand, count to three, then squeeze and release it once. They will be informed that they should continue this practice for 10 minutes and focus their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with single-use aseptic wipes before being given to the patient. During the biopsy procedure, the Visual Analog Scale (VAS), VAS-A, and hemodynamic variables of both the intervention and control groups will be evaluated again by the researchers at three time points
| Study group | Role | What they receive |
|---|---|---|
| stress ball | Experimental | After the preparation phase of the procedure is completed and the data collection form is filled out, patients will be given a stress ball, and its use will be demonstrated by E.K.D. The stress ball intervention will be performed during the biopsy procedure for an average duration of 10 minutes. A round, medium-firm silicone ball with an approximate diameter of 6 cm, made of high-quality materials, will be used in the application. Patients will be instructed to place the ball in the palm of their hand, count to three, then squeeze and release it once. They will be informed that they should continue this practice for 10 minutes and focus their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with single-use aseptic wipes before being given to the patient.
During the biopsy procedure, the Visual Analog Scale (VAS), VAS-A, and hemodynamic variables of both the intervention and control groups will be evaluated again by the researchers at three ti Receives: Other: Stress ball |
| control | No intervention | For the control group, no intervention other than routine care will be applied, and evaluations will be conducted at the same time points as for the intervention group. During the biopsy procedure, the Visual Analog Scale (VAS), VAS-A, and hemodynamic variables of control groups will be reassessed by the researchers at three time points: approximately 5 minutes after the start of the biopsy, immediately after the completion of the biopsy, and 15 minutes after the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
he Visual Analog Scale (VAS), developed by Freyd in 1923, is a single-line scale, 10 cm in length, which can be used either vertically or horizontally to assess pain intensity. Widely recognized in the literature as a safe and easily applicable tool, the VAS consists of a 10-cm line with subjective descriptive labels at both ends (0 cm = no pain, 10 cm = worst possible pain). Individuals mark the point on the line that corresponds to their perceived pain level. The distance from the start of the line to the marked point is measured with a ruler, and the individual's pain intensity is quantified in centimeters.
Measured: Before, During, immediately after, 15 minutes after biopsy
Secondary outcomes (6)
Visual Analog Scale for Anxiety (VAS-A)
The VAS was developed to convert certain values that cannot be measured numerically into numerical form. Widely recognized in the global literature as a safe and easily applicable tool, the VAS consists of a 10-cm line with subjective descriptive labels at both ends (0 cm = none, 10 cm = maximum). According to previous research, the VAS has been used to assess anxiety levels in surgical patients. Individuals mark the point on the 10-cm line that corresponds to their perceived anxiety. The distance from the start of the line to the marked point is measured with a ruler, and the individual's anxiety level is quantified in centimeters. A low score obtained from the VAS indicates a low/minimal level of anxiety, whereas a high score indicates a high/severe level of anxiety.
Measured: Before, During, immediately after, 15 minutes after biopsy
Systolic blood pressure changes after stress ball
This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.
Measured: Before, immediately after, 15 minutes after biopsy
Diastolic blood pressure changes after stress ball
This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.
Measured: Before, immediately after, 15 minutes after biopsy
Heart rate changes after stress ball
This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.
Measured: Before, immediately after, 15 minutes after biopsy
Respiratory rate changes after stress ball
This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.
Measured: Before, immediately after, 15 minutes after biopsy
Oxygen saturation values changes after stress ball
This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.
Measured: Before, immediately after, 15 minutes after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start6 Apr 2026
- Primary completion6 Apr 2026
- Study completion9 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba CAM YANIK, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507617
- Sponsor's protocol ID
- Mersin_Unıv
- Other IDs
- Tuğba ÇAM YANIK
- Acronym
- Stress ball
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07507617
- Acronym / sponsor ID
- Stress ball / Mersin_Unıv
- Conditions
- Stress
- Keywords
- Biopsy, Pain, Stress, Stress ball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 9 Oct 2026 (actual)
- First posted
- 2 Apr 2026 (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 Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables
Detailed description
Transrectal ultrasound (TRUS)-guided prostate biopsy is a standard and widely used invasive procedure in the diagnosis of prostate cancer. Tissue sampling is considered the gold standard for the early detection of prostate cancer, and TRUS-guided biopsy is the most commonly used method. As an invasive procedure performed under local anesthesia, it may lead to significant levels of anxiety and pain in patients. In particular, uncertainty prior to the procedure, fear of receiving a cancer diagnosis, and the transrectal route of intervention are among the main factors that increase the psychological burden. Consequently, changes in hemodynamic variables (such as heart rate and blood pressure) may also be observed.
The psychological stress experienced during this minimally invasive procedure may increase patients' perception of pain and negatively affect their tolerance. Increased levels of pain and anxiety may cause patients to move during the procedure, reduce cooperation, and prolong the duration of the procedure. Additionally, this situation may result in decreased patient comfort.
In the literature, both pharmacological and non-pharmacological methods have been identified to reduce pain and anxiety during prostate biopsy. Although pharmacological methods are effective, factors such as the risk of side effects, the need for sedation, and increased costs have led to a growing emphasis on non-pharmacological approaches in recent years. These approaches are attention-diverting, safe, and easy to implement. Non-pharmacological methods are among the core components of nursing care and support a patient-centered care approach. A meta-analysis conducted by He et al. found that music, one of the non-pharmacological methods, reduces pain and anxiety in patients undergoing prostate biopsy.
Another simple method that can be applied to patients is the use of a stress ball. The stress ball application, which allows patients to squeeze an object during procedures such as biopsy and helps divert their attention away from the procedure, is a simple and easily applicable non-pharmacological method aimed at reducing anxiety and pain perception. The mechanism of action of stress balls is based on suppressing the stress response through distraction, muscle relaxation, and enhancing the sense of control. It has been reported that stress balls reduce anxiety and pain levels during surgical and various interventional procedures, and also have positive effects on hemodynamic parameters such as heart rate and blood pressure. Randomized controlled studies conducted in different clinical settings, such as cataract surgery, endoscopy, angiography, and hemodialysis, have demonstrated that stress ball use increases patient comfort and reduces physiological stress responses. Additionally, in a study examining virtual reality and stress ball use during transrectal prostate biopsy, it was found that pain levels decreased 15 minutes after the procedure in the stress ball group compared to the control group (p < 0.05).
In the literature, there is no randomized controlled trial evaluating solely the effect of stress ball application on anxiety, pain, and hemodynamic parameters during TRUS-guided prostate biopsy. This highlights the need for further research to increase the level of evidence on this topic. Therefore, this study aims to evaluate the effect of stress ball use during TRUS-guided prostate biopsy on patients' anxiety and pain levels, as well as on hemodynamic variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stress ball | Experimental | Other: Stress ballAfter the preparation phase of the procedure is completed and the data collection form is filled out, patients will be given a stress ball, and its use will be demonstrated by E.K.D. The stress ball intervention will be performed during the biopsy procedure for an average duration of 10 minutes. A round, medium-firm silicone ball with an approximate diameter of 6 cm, made of high-quality materials, will be used in the application. Patients will be instructed to place the ball in the palm of their hand, count to three, then squeeze and release it once. They will be informed that they should continue this practice for 10 minutes and focus their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with single-use aseptic wipes before being given to the patient. During the biopsy procedure, the Visual Analog Scale (VAS), VAS-A, and hemodynamic variables of both the intervention and control groups will be evaluated again by the researchers at three ti |
| control | No intervention | –For the control group, no intervention other than routine care will be applied, and evaluations will be conducted at the same time points as for the intervention group. During the biopsy procedure, the Visual Analog Scale (VAS), VAS-A, and hemodynamic variables of control groups will be reassessed by the researchers at three time points: approximately 5 minutes after the start of the biopsy, immediately after the completion of the biopsy, and 15 minutes after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 years or older,
- Conscious and cooperative,
- Able to speak and understand Turkish,
- With stable general condition and hemodynamic variables,
- Scheduled for the procedure,
Key exclusion criteria (8 listed)
- Under 18 years of age,
- Not conscious or not cooperative,
- Unable to speak or understand Turkish,
- With unstable general condition or hemodynamic variables,
- Undergoing emergency surgical procedures,
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 ballThe stress ball intervention will be performed during the biopsy procedure for an average duration of 10 minutes. A round, medium-firm silicone ball with an approximate diameter of 6 cm, made of high-quality materials, will be used in the application. Patients will be instructed to place the ball in the palm of their hand, count to three, then squeeze and release it once. They will be informed that they should continue this practice for 10 minutes and focus their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with single-use aseptic wipes before being given to the patient. During the biopsy procedure, the Visual Analog Scale (VAS), VAS-A, and hemodynamic variables of both the intervention and control groups will be evaluated again by the researchers at three time points | Other | stress ball |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Before, During, immediately after, 15 minutes after biopsy
he Visual Analog Scale (VAS), developed by Freyd in 1923, is a single-line scale, 10 cm in length, which can be used either vertically or horizontally to assess pain intensity. Widely recognized in the literature as a safe and easily applicable tool, the VAS consists of a 10-cm line with subjective descriptive labels at both ends (0 cm = no pain, 10 cm = worst possible pain). Individuals mark the point on the line that corresponds to their perceived pain level. The distance from the start of the line to the marked point is measured with a ruler, and the individual's pain intensity is quantified in centimeters.
6 secondary outcomes
Visual Analog Scale for Anxiety (VAS-A)
Time frame: Before, During, immediately after, 15 minutes after biopsy
Systolic blood pressure changes after stress ball
Time frame: Before, immediately after, 15 minutes after biopsy
Diastolic blood pressure changes after stress ball
Time frame: Before, immediately after, 15 minutes after biopsy
Heart rate changes after stress ball
Time frame: Before, immediately after, 15 minutes after biopsy
Respiratory rate changes after stress ball
Time frame: Before, immediately after, 15 minutes after biopsy
Oxygen saturation values changes after stress ball
Time frame: Before, immediately after, 15 minutes after biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress ball in people with Stress, run by Mersin University at 1 site in Turkey (Türkiye).
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scale (VAS) (time frame: Before, During, immediately after, 15 minutes after biopsy). 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 20 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.