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

NCT07613736 | Completed

• 2 other identifiers: 2026/39BSKEAH-2026-39
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Response; Procedural Pain; Anxiety; Tru-Cut Biopsy

Keywords

Tru-cut biopsy; Procedural pain; Stress ball; Anxiety; Nonpharmacological intervention; Nursing intervention

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental: Stress Ball Application

EXPERIMENTAL

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

No Intervention: Standard Care

NO INTERVENTION

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.

Interventions

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.

Experimental: Stress Ball Application

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead
• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: collaborator

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, 34000, Turkey (Türkiye)

Location

Related Links

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

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders; Fractures, Stress

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Fractures, Bone; Wounds and Injuries

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: Oncology Nurse, PhD Candidate

Model Details: Participants were randomly assigned in a 1:1 ratio to either the intervention group receiving stress ball application during the ultrasound-guided tru-cut biopsy procedure or the control group receiving standard care alone. The intervention and control groups were followed in parallel throughout the study, and outcome measures were assessed before and after the procedure.

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: May 29, 2026
• Study Start: March 15, 2026
• Primary Completion: April 15, 2026
• Study Completion: May 15, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)