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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Stress Response; Procedural Pain; Tru-Cut Biopsy
• Intervention / Treatment: Behavioral: Behavioral: Stress Ball Application

Detailed Description

A Tru-cut biopsy is a minimally invasive diagnostic procedure frequently used to evaluate suspicious lesions and tissue abnormalities. Although local anesthesia is routinely administered, patients commonly experience procedural pain, anxiety, and physiological stress responses during the procedure. Increased anxiety levels may negatively influence pain perception, procedural tolerance, and overall patient experience.

Nonpharmacological interventions have increasingly gained attention as supportive approaches for reducing pain and anxiety during invasive procedures. Among these interventions, distraction techniques are considered practical, low-cost, and easy to implement in clinical settings. Stress ball application is a simple distraction-based intervention that encourages active patient participation and may help redirect attention away from the procedure.

This study was designed as a prospective, single-center, parallel-group randomized controlled trial to evaluate the effect of stress ball application on pain, anxiety, and vital signs during ultrasound-guided Tru-Cut biopsy procedures. Participants were randomly assigned in a 1:1 ratio to either the intervention group, which received stress ball application during the procedure, or the control group, which received standard care alone.

Pain intensity was assessed using the Visual Analog Scale (VAS), and anxiety levels were evaluated using the State-Trait Anxiety Inventory (STAI Form TX-I). Vital signs, including systolic and diastolic blood pressure and heart rate, were recorded before and after the procedure. The study aimed to determine whether the use of stress balls could reduce procedural pain and anxiety and improve physiological responses during Tru-Cut biopsy procedures.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34000
      • Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Aged 18 years or older Scheduled for an ultrasound-guided tru-cut biopsy procedure Conscious and able to communicate Able to understand and respond to the study forms Provided written informed consent Patients with or without previous biopsy experience

Exclusion Criteria:

Received sedation prior to the procedure Had cognitive impairment or communication difficulties Had upper extremity limitations preventing stress ball use Experienced complications during the procedure Refused to participate in the study

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Stress Ball Application; Experimental Arm Description Participants in the experimental group received stress ball application during the ultrasound-guided tru-cut biopsy procedure in addition to standard care. Patients were instructed to squeeze the stress ball continuously throughout the procedure as a distraction-based nonpharmacological intervention. Pain intensity, anxiety levels, and vital signs were assessed before and after the procedure. Control Arm Description Participants in the control group received routine standard care during the ultrasound-guided tru-cut biopsy procedure. No additional nonpharmacological intervention was applied. Pain intensity, anxiety levels, and vital signs were assessed before and after the procedure.	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.
No Intervention: No Intervention: Standard Care; Participants in the control group received routine standard care during the ultrasound-guided tru-cut biopsy procedure. No additional nonpharmacological intervention or distraction technique was applied. Pain intensity, anxiety levels, and vital signs were assessed before and after the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-procedural Pain Intensity	Pain intensity assessed after the ultrasound-guided tru-cut biopsy procedure using the Visual Analog Scale (VAS). Higher scores indicate greater pain intensity.	Immediately after the procedure
Change in State Anxiety Level	Change in anxiety level measured using the State-Trait Anxiety Inventory Form TX-I (STAI) before and after the ultrasound-guided tru-cut biopsy procedure. Higher scores indicate higher anxiety levels	Before and immediately after the procedure

Collaborators and Investigators

• Sponsor: Istanbul University
• Collaborators: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

Helpful Links

• "Randomized controlled trial evaluating the effect of stress ball application on pain and anxiety during angiography procedures."

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2026
• Primary Completion (Actual): April 15, 2026
• Study Completion (Actual): May 15, 2026

Study Registration Dates

• First Submitted: May 23, 2026
• First Submitted That Met QC Criteria: May 23, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 23, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Procedural pain; Nursing intervention; Stress ball; Tru-cut biopsy; Nonpharmacological intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Wounds and Injuries; Fractures, Bone; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Anxiety Disorders; Fractures, Stress
• Other Study ID Numbers: 2026/39; BSKEAH-2026-39 (Other Identifier: Bakirkoy Dr. Sadi Konuk Training and Research Hospital)

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