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COMPLETED
NCT07613736
NA

Effect of Stress Ball Use on Pain, Anxiety, and Vital Signs During Ultrasound-Guided Tru-cut Biopsy

Sponsor: Istanbul University

View on ClinicalTrials.gov

Summary

This randomized controlled trial aims to evaluate the effect of stress ball application on pain, anxiety, and vital signs in adult patients undergoing ultrasound-guided tru-cut biopsy procedures. Tru-cut biopsy is a commonly performed invasive diagnostic procedure that may cause procedural pain and anxiety despite standard local anesthesia. Nonpharmacological interventions such as distraction techniques may improve patient comfort during the procedure. Participants are randomly assigned to either an intervention group receiving a stress ball application during the biopsy procedure or a control group receiving standard care alone. Pain intensity is assessed using the Visual Analog Scale (VAS), anxiety levels are evaluated using the State-Trait Anxiety Inventory (STAI Form TX-I), and vital signs are recorded before and after the procedure. The study is conducted at a single tertiary care training and research hospital and includes 79 adult participants. The primary objective of the study is to determine whether stress ball use reduces procedural pain and anxiety during Tru-Cut biopsy procedures. Secondary outcomes include changes in systolic blood pressure, diastolic blood pressure, heart rate, and procedure duration.

Official title: The Effect of Stress Ball Application on Pain, Anxiety, and Vital Signs During Ultrasound-Guided Tru-Cut Biopsy Procedures: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

79

Start Date

2026-03-15

Completion Date

2026-05-15

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

BEHAVIORAL

Behavioral: Stress Ball Application

Participants in the intervention group received stress ball application during the ultrasound-guided tru-cut biopsy procedure in addition to routine standard care. Patients were instructed to continuously squeeze a medium-resistance stress ball throughout the procedure as a distraction-based nonpharmacological intervention aimed at reducing procedural pain and anxiety. The intervention was applied only during the biopsy procedure, and no pharmacological or additional behavioral intervention was administered as part of the study.

Locations (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)