AnxietyNCT07101172
The Effectiveness of Stress Ball in Managing Anxiety and Pain During Prostate Biopsy
A study testing stress ball in people with Anxiety and Pain, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effectiveness of stress ball application in the management of anxiety and pain during prostate biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pain, Prostate Biopsy
- What is being tested?
- stress ball
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who come to the Urology Service for a prostate biopsy, are willing to participate in the study, are over 18 years of age, are conscious, literate, have no visual or hearing impairments, no psychiatric diagnoses or neurological problems, are undergoing a prostate biopsy for the first time, and do not have weakness in their hands or arms to squeeze a ball will be included.
Who cannot join
- Patients who do not volunteer to participate in the study, who wish to withdraw from the study, who are under 18 years of age, who are unconscious, illiterate, visually or hearing impaired, who have a psychiatric diagnosis or neurological problem, who have previously had a prostate biopsy, and who have weakness in the hand or arm for the ability to squeeze a ball will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Simple Approach to Managing Anxiety and Pain During Prostate Biopsy: Effectiveness of Stress Ball Application
This study aimed to determine the effectiveness of stress ball application in the management of anxiety and pain during prostate biopsy.
Read the detailed description
The aim of this study was to determine the effectiveness of stress ball application in managing anxiety and pain during prostate biopsy.
This experimental study was performed with experimental-control group (N=66) patients.Data will be collected using the "Personal Information Form", "Visual Analog Scale (VAS)", "State Anxiety Inventory (STAI-S)" and "Patient Follow-up Form".
- Conditions
- Anxiety, Pain, Prostate Biopsy
- Being tested
- stress ball
- Keywords
- Anxiety, Pain, Prostate Biopsy, Stress Ball
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ballProcedure or surgery
Patients will be provided with an explanation, and verbal and written consent will be obtained. A patient identification form will be completed 10 minutes before the procedure. Pain levels will be determined with a pre-test VAS, anxiety levels will be determined with a STAI-S, and vital signs will be measured and recorded. The patient will be undressed and helped into a surgical gown to protect their privacy. The patient will be placed in a left lateral position on a stretcher with both legs drawn up toward their abdomen. The environment will be quiet and free from external stimuli. During the biopsy procedure, the patient will be asked to squeeze and release the Stre ball once every five counts for 10 minutes. Because blood pressure may drop or dizziness may occur after the procedure, the patient will be taken to the recovery room and monitored for bleeding. Fifteen minutes after the procedure, the severity of pain and anxiety levels during the procedure will be determined, and vital
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball | Experimental | Not described Receives: Procedure: stress ball |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
Personal Information Form : This form, developed by the researcher based on literature, includes the age, education level, marital status, employment status, income level, daily pain coping strategies, stress coping strategies, previous surgery history, and whether patients are aware of prostate biopsy. It consists of nine questions . It will be used to determine the individual characteristics of the patient.
Measured: 12 months
Visual Analog Scale (VAS)
Visual Analog Scale (VAS) : This scale is used to assess the severity of pain. It is usually a 10 cm long horizontal or vertical line that begins with "No pain" and ends with "Unbearable pain." It will be used to determine the patient's pain intensity.
Measured: 12 months
State Anxiety Inventory (STAI-S)
State Anxiety Inventory (STAI-S) (Appendix 3): The State Anxiety Inventory has two subscales, each consisting of 20 items. The State Anxiety Inventory (STAI-S) describes how individuals feel under different circumstances and in the moment, while the Trait Anxiety Inventory (STAI-T) describes how they generally feel in their lives. The inventory is a 4-point Likert-type scale, with ratings based on the severity of the emotions and behaviors in the State and Trait Anxiety Subscales. According to the results, average anxiety scores range from 36 to 41, with scores above indicating high anxiety and below indicating low anxiety. It will be used to determine the patient's anxiety level.
Measured: 12 months
Patient Follow-up Form
Patient Follow-up Form: This is the form created to record the vital signs of the patients [pulse, respiratory rate, systolic blood pressure (SBP), diastolic blood pressure (DBP) and oxygen saturation values (SpO2)) measured by the researcher before and after the procedure. It will be used to monitor and evaluate the patient's vital signs.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra UNAL, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101172
- Sponsor's protocol ID
- HititZU
- Status last verified
- Sep 2025
- First submitted
- 24 Jul 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Approach to Managing Anxiety and Pain During Prostate Biopsy: Effectiveness of Stress Ball Application
- ClinicalTrials.gov ID
- NCT07101172
- Acronym / sponsor ID
- HititZU
- Conditions
- Anxiety, Pain, Prostate Biopsy
- Keywords
- Anxiety, Pain, Prostate Biopsy, Stress Ball
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 3 Aug 2025 (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.
This study aimed to determine the effectiveness of stress ball application in the management of anxiety and pain during prostate biopsy.
Detailed description
The aim of this study was to determine the effectiveness of stress ball application in managing anxiety and pain during prostate biopsy.
This experimental study was performed with experimental-control group (N=66) patients.Data will be collected using the "Personal Information Form", "Visual Analog Scale (VAS)", "State Anxiety Inventory (STAI-S)" and "Patient Follow-up Form".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Ball | Experimental | Procedure: stress ball |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who come to the Urology Service for a prostate biopsy, are willing to participate in the study, are over 18 years of age, are conscious, literate, have no visual or hearing impairments, no psychiatric diagnoses or neurological problems, are undergoing a prostate biopsy for the first time, and do not have weakness in their hands or arms to squeeze a ball will be included.
Key exclusion criteria (1 listed)
- Patients who do not volunteer to participate in the study, who wish to withdraw from the study, who are under 18 years of age, who are unconscious, illiterate, visually or hearing impaired, who have a psychiatric diagnosis or neurological problem, who have previously had a prostate biopsy, and who have weakness in the hand or arm for the ability to squeeze a ball will be excluded from the study.
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 ballPatients will be provided with an explanation, and verbal and written consent will be obtained. A patient identification form will be completed 10 minutes before the procedure. Pain levels will be determined with a pre-test VAS, anxiety levels will be determined with a STAI-S, and vital signs will be measured and recorded. The patient will be undressed and helped into a surgical gown to protect their privacy. The patient will be placed in a left lateral position on a stretcher with both legs drawn up toward their abdomen. The environment will be quiet and free from external stimuli. During the biopsy procedure, the patient will be asked to squeeze and release the Stre ball once every five counts for 10 minutes. Because blood pressure may drop or dizziness may occur after the procedure, the patient will be taken to the recovery room and monitored for bleeding. Fifteen minutes after the procedure, the severity of pain and anxiety levels during the procedure will be determined, and vital | Procedure or surgery | Stress Ball |
Primary outcome
Personal Information Form
Time frame: 12 months
Personal Information Form : This form, developed by the researcher based on literature, includes the age, education level, marital status, employment status, income level, daily pain coping strategies, stress coping strategies, previous surgery history, and whether patients are aware of prostate biopsy. It consists of nine questions . It will be used to determine the individual characteristics of the patient.
Visual Analog Scale (VAS)
Time frame: 12 months
Visual Analog Scale (VAS) : This scale is used to assess the severity of pain. It is usually a 10 cm long horizontal or vertical line that begins with "No pain" and ends with "Unbearable pain." It will be used to determine the patient's pain intensity.
State Anxiety Inventory (STAI-S)
Time frame: 12 months
State Anxiety Inventory (STAI-S) (Appendix 3): The State Anxiety Inventory has two subscales, each consisting of 20 items. The State Anxiety Inventory (STAI-S) describes how individuals feel under different circumstances and in the moment, while the Trait Anxiety Inventory (STAI-T) describes how they generally feel in their lives. The inventory is a 4-point Likert-type scale, with ratings based on the severity of the emotions and behaviors in the State and Trait Anxiety Subscales. According to the results, average anxiety scores range from 36 to 41, with scores above indicating high anxiety and below indicating low anxiety. It will be used to determine the patient's anxiety level.
Patient Follow-up Form
Time frame: 12 months
Patient Follow-up Form: This is the form created to record the vital signs of the patients [pulse, respiratory rate, systolic blood pressure (SBP), diastolic blood pressure (DBP) and oxygen saturation values (SpO2)) measured by the researcher before and after the procedure. It will be used to monitor and evaluate the patient's vital signs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- 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.
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 Anxiety and Pain, run by Hitit 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 22 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Personal Information Form (time frame: 12 months). The study lists 4 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 22 Sep 2025.