Breast BiopsyNCT07844395
The Effect of Using a Stress Ball on Pain, Anxiety, and Vital Signs During Breast Biopsy
A study testing Using a Stress Ball in people with Breast Biopsy and Procedural Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Breast biopsy is an invasive diagnostic procedure commonly performed for the histopathological diagnosis of breast lesions and can be associated with anxiety and pain. Procedural anxiety and pain may also influence physiological responses, including changes in blood pressure and heart rate. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Biopsy, Procedural Pain, Anxiety
- What is being tested?
- Using a Stress Ball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2026to 31 Oct 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for Tru-Cut breast biopsy
- Aged 18 years and older
- Undergoing breast biopsy for the first time
- Able to speak Turkish
- Female sex
- Not pregnant
Show all 9Show fewer
- Not breastfeeding
- No cognitive, verbal, or hearing impairments that could impede communication
- Voluntarily agreeing to participate in the study with written and verbal informed consent
Who cannot join
- Chronic pain disorders or regular use of analgesics
- Having taken analgesic medication on the day of the procedure
- Inability to use the hands or impaired grip/grasp function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University Faculty of Medicine Hospitals
Kayseri
Evrim Bayraktar, Assoc. Prof. Dr., +90 352 437 9281, ealbayrak@erciyes.edu.tr
About this study
Breast biopsy is an invasive diagnostic procedure commonly performed for the histopathological diagnosis of breast lesions and can be associated with anxiety and pain. Procedural anxiety and pain may also influence physiological responses, including changes in blood pressure and heart rate. Therefore, non-pharmacological nursing interventions that are simple, low-cost, and easy to implement may be useful in managing procedural distress.
This study aims to investigate the effect of stress ball use during breast biopsy on patients' pain, anxiety, and vital signs. Participants will be assigned to an intervention group using a stress ball during the biopsy procedure or a control group receiving standard care. Pain and anxiety levels, as well as vital signs, will be assessed and compared between the two groups.
- Conditions
- Breast Biopsy, Procedural Pain, Anxiety, Vital Signs
- Being tested
- Using a Stress Ball
- Keywords
- stress ball, distraction, nursing intervention
- Medical subject headings
- Pain, Procedural, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using a Stress BallBehavioural
Participants will squeeze a stress ball during the biopsy procedure
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball | Experimental | Participants in this group will squeeze a stress ball during the breast biopsy procedure. Receives: Behavioral: Using a Stress Ball |
| Routine Care | No intervention | Participants will receive standard care without any stress ball application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score Assessed by Visual Analog Scale (VAS)
Pain intensity will be evaluated using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.
Measured: Immediately after the biopsy procedure
Secondary outcomes (8)
Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-S)
Situational anxiety will be assessed using the State Anxiety Scale (STAI-S). Scores range from 20 to 80, with higher scores reflecting higher anxiety levels.
Measured: Baseline (before the procedure) and immediately after the biopsy procedure
Trait Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-T)
General anxiety disposition will be assessed using the Trait Anxiety Scale (STAI Form TX-2 / STAI-T). The total score ranges from 20 to 80, with higher scores reflecting higher levels of trait anxiety.
Measured: Immediately after the biopsy procedure
Changes in Vital Signs (Body Temperature)
Body temperature (°C) will be recorded.
Measured: Baseline (before the procedure) and immediately after the biopsy procedure
Changes in Vital Signs (Heart Rate)
Heart rate will be recorded in beats per minute (bpm).
Measured: Baseline (before the procedure) and immediately after the biopsy procedure
Changes in Vital Signs (Respiratory Rate)
Respiratory rate will be recorded in breaths per minute.
Measured: Baseline (before the procedure) and immediately after the biopsy procedure
Changes in Vital Signs (Systolic Blood Pressure)
Systolic blood pressure (mmHg) will be recorded.
Measured: Baseline (before the procedure) and immediately after the biopsy procedure
Changes in Vital Signs (Diastolic Blood Pressure)
Diastolic blood pressure (mmHg) will be recorded.
Measured: Baseline (before the procedure) and immediately after the biopsy procedure
Changes in Vital Signs (Peripheral Oxygen Saturation)
Peripheral oxygen saturation (SpO2, %) will be recorded.
Measured: Baseline (before the procedure) and immediately after the biopsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start11 Sep 2026
- Primary completion11 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast BiopsyStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Tugba Ton, TC Erciyes University
- Investigators
- Evrim Bayraktar, Assoc. Prof. Dr., Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844395
- Sponsor's protocol ID
- TYL-2026-15599
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using a Stress Ball on Pain, Anxiety, and Vital Signs During Breast Biopsy
- ClinicalTrials.gov ID
- NCT07844395
- Acronym / sponsor ID
- TYL-2026-15599
- Conditions
- Breast Biopsy, Procedural Pain, Anxiety, Vital Signs
- Keywords
- stress ball, distraction, nursing intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- 11 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 28 Sep 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.
Breast biopsy is an invasive diagnostic procedure commonly performed for the histopathological diagnosis of breast lesions and can be associated with anxiety and pain. Procedural anxiety and pain may also influence physiological responses, including changes in blood pressure and heart rate. Therefore, non-pharmacological nursing interventions that are simple, low-cost, and easy to implement may be useful in managing procedural distress.
This study aims to investigate the effect of stress ball use during breast biopsy on patients' pain, anxiety, and vital signs. Participants will be assigned to an intervention group using a stress ball during the biopsy procedure or a control group receiving standard care. Pain and anxiety levels, as well as vital signs, will be assessed and compared between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Ball | Experimental | Behavioral: Using a Stress BallParticipants in this group will squeeze a stress ball during the breast biopsy procedure. |
| Routine Care | No intervention | –Participants will receive standard care without any stress ball application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Scheduled for Tru-Cut breast biopsy
- Aged 18 years and older
- Undergoing breast biopsy for the first time
- Able to speak Turkish
- Female sex
Key exclusion criteria (3 listed)
- Chronic pain disorders or regular use of analgesics
- Having taken analgesic medication on the day of the procedure
- Inability to use the hands or impaired grip/grasp function
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 |
|---|---|---|
| Using a Stress BallParticipants will squeeze a stress ball during the biopsy procedure | Behavioural | Stress Ball |
Primary outcome
Pain Score Assessed by Visual Analog Scale (VAS)
Time frame: Immediately after the biopsy procedure
Pain intensity will be evaluated using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.
8 secondary outcomes
Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-S)
Time frame: Baseline (before the procedure) and immediately after the biopsy procedure
Trait Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-T)
Time frame: Immediately after the biopsy procedure
Changes in Vital Signs (Body Temperature)
Time frame: Baseline (before the procedure) and immediately after the biopsy procedure
Changes in Vital Signs (Heart Rate)
Time frame: Baseline (before the procedure) and immediately after the biopsy procedure
Changes in Vital Signs (Respiratory Rate)
Time frame: Baseline (before the procedure) and immediately after the biopsy procedure
Changes in Vital Signs (Systolic Blood Pressure)
Time frame: Baseline (before the procedure) and immediately after the biopsy procedure
Changes in Vital Signs (Diastolic Blood Pressure)
Time frame: Baseline (before the procedure) and immediately after the biopsy procedure
Changes in Vital Signs (Peripheral Oxygen Saturation)
Time frame: Baseline (before the procedure) and immediately after the biopsy procedure
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 28 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Evrim Bayraktar, Assoc. Prof. Dr. study director
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using a Stress Ball in people with Breast Biopsy and Procedural Pain, run by TC Erciyes 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 9 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Sep 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?
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?
Contact Evrim Bayraktar, Assoc. Prof. Dr. (+905332156825, ealbayrak@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score Assessed by Visual Analog Scale (VAS) (time frame: Immediately after the biopsy procedure). 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 28 Sep 2026.