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

NCT07844395 | Recruiting

• 1 other identifier: TYL-2026-15599
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

stress ball; distraction; nursing intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after the biopsy procedure

Secondary Outcomes (8)

• Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-S)

  Baseline (before the procedure) and immediately after the biopsy procedure

• Trait Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-T)

  Immediately after the biopsy procedure

• Changes in Vital Signs (Body Temperature)

  Baseline (before the procedure) and immediately after the biopsy procedure

• Changes in Vital Signs (Heart Rate)

  Baseline (before the procedure) and immediately after the biopsy procedure

• Changes in Vital Signs (Respiratory Rate)

  Baseline (before the procedure) and immediately after the biopsy procedure

Study Arms (2)

Stress Ball

EXPERIMENTAL

Participants in this group will squeeze a stress ball during the breast biopsy procedure.

Behavioral: Using a Stress Ball

Routine Care

NO INTERVENTION

Participants will receive standard care without any stress ball application.

Interventions

Using a Stress Ball BEHAVIORAL

Participants will squeeze a stress ball during the biopsy procedure

Stress Ball

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Medicine Hospitals

Kayseri, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Evrim Bayraktar, Assoc. Prof. Dr.

  TC Erciyes University

  STUDY DIRECTOR

Central Study Contacts

Evrim Bayraktar, Assoc. Prof. Dr.

CONTACT

+905332156825; ealbayrak@erciyes.edu.tr

Meryem Tuğba Ton, RN, BSN

CONTACT

+905078781249; meryemtubaton@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 28, 2026
• Study Start: September 11, 2026
• Primary Completion (Estimated): October 11, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)