The Effect of Using a Stress Ball on Pain, Anxiety, and Vital Signs During Breast Biopsy

September 21, 2026 updated by: Meryem Tugba Ton, TC Erciyes University

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Kayseri, Turkey (Türkiye)
        • Recruiting
        • Erciyes University Faculty of Medicine Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stress Ball

Participants in this group will squeeze a stress ball during the breast biopsy procedure.
Behavioral: Using a Stress Ball

Participants will squeeze a stress ball during the biopsy procedure
No Intervention: Routine Care

Participants will receive standard care without any stress ball application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after the biopsy procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-S)
Time Frame: Baseline (before the procedure) and immediately after the biopsy procedure

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.
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

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.
Immediately after the biopsy procedure
Changes in Vital Signs (Body Temperature)
Time Frame: Baseline (before the procedure) and immediately after the biopsy procedure

Body temperature (°C) will be recorded.
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

Heart rate will be recorded in beats per minute (bpm).
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

Respiratory rate will be recorded in breaths per minute.
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

Systolic blood pressure (mmHg) will be recorded.
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

Diastolic blood pressure (mmHg) will be recorded.
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

Peripheral oxygen saturation (SpO2, %) will be recorded.
Baseline (before the procedure) and immediately after the biopsy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Study Director: Evrim Bayraktar, Assoc. Prof. Dr., TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2026

Primary Completion (Estimated)

October 11, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

September 16, 2026

First Submitted That Met QC Criteria

September 21, 2026

First Posted (Actual)

September 28, 2026

Study Record Updates

Last Update Posted (Actual)

September 28, 2026

Last Update Submitted That Met QC Criteria

September 21, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYL-2026-15599

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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