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Completed

NCT Number: NCT07613736

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Behavioral: Stress Ball Application

Behavioral

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.

Primary outcomes

  1. Post-procedural Pain Intensity

    Time frame: Immediately after the procedure

    Pain intensity assessed after the ultrasound-guided tru-cut biopsy procedure using the Visual Analog Scale (VAS). Higher scores indicate greater pain intensity.

  2. Change in State Anxiety Level

    Time frame: Before and immediately after the procedure

    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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Registry information

Official study title

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

Acronym: STRESS-BX

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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