Skip to main content
Clinical Trials/NCT07613736
NCT07613736CompletedNot Applicable

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

Istanbul University1 site in 1 country79 target enrollmentStarted: March 15, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
79
Locations
1

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yagmur Berktas

Oncology Nurse, PhD Candidate

Istanbul University

Study Sites (1)

Loading locations...

Similar Trials