The Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables (Stress ball)

The Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables: A Randomized Controlled Trial

The Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables

Study Overview

• Status: Not yet recruiting
• Conditions: Stress
• Intervention / Treatment: Other: Stress ball

Detailed Description

Transrectal ultrasound (TRUS)-guided prostate biopsy is a standard and widely used invasive procedure in the diagnosis of prostate cancer. Tissue sampling is considered the gold standard for the early detection of prostate cancer, and TRUS-guided biopsy is the most commonly used method. As an invasive procedure performed under local anesthesia, it may lead to significant levels of anxiety and pain in patients. In particular, uncertainty prior to the procedure, fear of receiving a cancer diagnosis, and the transrectal route of intervention are among the main factors that increase the psychological burden. Consequently, changes in hemodynamic variables (such as heart rate and blood pressure) may also be observed.

The psychological stress experienced during this minimally invasive procedure may increase patients' perception of pain and negatively affect their tolerance. Increased levels of pain and anxiety may cause patients to move during the procedure, reduce cooperation, and prolong the duration of the procedure. Additionally, this situation may result in decreased patient comfort.

In the literature, both pharmacological and non-pharmacological methods have been identified to reduce pain and anxiety during prostate biopsy. Although pharmacological methods are effective, factors such as the risk of side effects, the need for sedation, and increased costs have led to a growing emphasis on non-pharmacological approaches in recent years. These approaches are attention-diverting, safe, and easy to implement. Non-pharmacological methods are among the core components of nursing care and support a patient-centered care approach. A meta-analysis conducted by He et al. found that music, one of the non-pharmacological methods, reduces pain and anxiety in patients undergoing prostate biopsy.

Another simple method that can be applied to patients is the use of a stress ball. The stress ball application, which allows patients to squeeze an object during procedures such as biopsy and helps divert their attention away from the procedure, is a simple and easily applicable non-pharmacological method aimed at reducing anxiety and pain perception. The mechanism of action of stress balls is based on suppressing the stress response through distraction, muscle relaxation, and enhancing the sense of control. It has been reported that stress balls reduce anxiety and pain levels during surgical and various interventional procedures, and also have positive effects on hemodynamic parameters such as heart rate and blood pressure. Randomized controlled studies conducted in different clinical settings, such as cataract surgery, endoscopy, angiography, and hemodialysis, have demonstrated that stress ball use increases patient comfort and reduces physiological stress responses. Additionally, in a study examining virtual reality and stress ball use during transrectal prostate biopsy, it was found that pain levels decreased 15 minutes after the procedure in the stress ball group compared to the control group (p < 0.05).

In the literature, there is no randomized controlled trial evaluating solely the effect of stress ball application on anxiety, pain, and hemodynamic parameters during TRUS-guided prostate biopsy. This highlights the need for further research to increase the level of evidence on this topic. Therefore, this study aims to evaluate the effect of stress ball use during TRUS-guided prostate biopsy on patients' anxiety and pain levels, as well as on hemodynamic variables.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tuğba YANIK, PHD; Phone Number: +905067703216; Email: tugbacam@mersin.edu.tr

Study Locations

• Turkey (Türkiye)
  • Mersin
    • Yenişehir, Mersin, Turkey (Türkiye), 33120
      • Turkey, Mersin University,
      • Contact: Tuğba ÇAM YANIK; Phone Number: 05067703216; Email: tugbacam@mersin.edu.tr

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Aged 18 years or older,
• Conscious and cooperative,
• Able to speak and understand Turkish,
• With stable general condition and hemodynamic variables,
• Scheduled for the procedure,
• Without any psychiatric diagnosis,
• Not using psychiatric and/or local neuromuscular blocking medications,
• Willing to participate in the study (having signed the Informed Consent Form).

Exclusion Criteria:

• Under 18 years of age,
• Not conscious or not cooperative,
• Unable to speak or understand Turkish,
• With unstable general condition or hemodynamic variables,
• Undergoing emergency surgical procedures,
• Having a current psychiatric diagnosis,
• Using psychiatric and/or local neuromuscular blocking medications,
• Unwilling to participate in the study (not signing the Informed Consent Form).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stress ball; After the preparation phase of the procedure is completed and the data collection form is filled out, patients will be given a stress ball, and its use will be demonstrated by E.K.D. The stress ball intervention will be performed during the biopsy procedure for an average duration of 10 minutes. A round, medium-firm silicone ball with an approximate diameter of 6 cm, made of high-quality materials, will be used in the application. Patients will be instructed to place the ball in the palm of their hand, count to three, then squeeze and release it once. They will be informed that they should continue this practice for 10 minutes and focus their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with single-use aseptic wipes before being given to the patient. During the biopsy procedure, the Visual Analog Scale (VAS), VAS-A, and hemodynamic variables of both the intervention and control groups will be evaluated again by the researchers at three ti	Other: Stress ball; The stress ball intervention will be performed during the biopsy procedure for an average duration of 10 minutes. A round, medium-firm silicone ball with an approximate diameter of 6 cm, made of high-quality materials, will be used in the application. Patients will be instructed to place the ball in the palm of their hand, count to three, then squeeze and release it once. They will be informed that they should continue this practice for 10 minutes and focus their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with single-use aseptic wipes before being given to the patient. During the biopsy procedure, the Visual Analog Scale (VAS), VAS-A, and hemodynamic variables of both the intervention and control groups will be evaluated again by the researchers at three time points
No Intervention: control; For the control group, no intervention other than routine care will be applied, and evaluations will be conducted at the same time points as for the intervention group. During the biopsy procedure, the Visual Analog Scale (VAS), VAS-A, and hemodynamic variables of control groups will be reassessed by the researchers at three time points: approximately 5 minutes after the start of the biopsy, immediately after the completion of the biopsy, and 15 minutes after the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	he Visual Analog Scale (VAS), developed by Freyd in 1923, is a single-line scale, 10 cm in length, which can be used either vertically or horizontally to assess pain intensity. Widely recognized in the literature as a safe and easily applicable tool, the VAS consists of a 10-cm line with subjective descriptive labels at both ends (0 cm = no pain, 10 cm = worst possible pain). Individuals mark the point on the line that corresponds to their perceived pain level. The distance from the start of the line to the marked point is measured with a ruler, and the individual's pain intensity is quantified in centimeters.	Before, During, immediately after, 15 minutes after biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate changes after stress ball	This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.	Before, immediately after, 15 minutes and 30 minutes after chest tube removal
Visual Analog Scale for Anxiety (VAS-A)	The VAS was developed to convert certain values that cannot be measured numerically into numerical form. Widely recognized in the global literature as a safe and easily applicable tool, the VAS consists of a 10-cm line with subjective descriptive labels at both ends (0 cm = none, 10 cm = maximum). According to previous research, the VAS has been used to assess anxiety levels in surgical patients. Individuals mark the point on the 10-cm line that corresponds to their perceived anxiety. The distance from the start of the line to the marked point is measured with a ruler, and the individual's anxiety level is quantified in centimeters. A low score obtained from the VAS indicates a low/minimal level of anxiety, whereas a high score indicates a high/severe level of anxiety.	Before, During, immediately after, 15 minutes after biopsy
Systolic blood pressure changes after stress ball	This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.	Before, During, immediately after, 15 minutes after biopsy
Diastolic blood pressure changes after stress ball	This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.	Before, immediately after, 15 minutes and 30 minutes after biopsy
Heart rate changes after stress ball	This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.	Before, immediately after, 15 minutes and 30 minutes after biopsy
Oxygen saturation values changes after stress ball	This form will record the systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation values of the study and control groups measured at the specified times. Hemodynamic variables will be monitored and recorded using a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department, in accordance with hospital policy.	Before, immediately after, 15 minutes and 30 minutes after biopsy

Collaborators and Investigators

• Sponsor: Mersin University

Study record dates

Study Major Dates

• Study Start (Estimated): April 6, 2026
• Primary Completion (Estimated): April 6, 2026
• Study Completion (Estimated): April 6, 2027

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Stress; Biopsy; Stress ball
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: Mersin_Unıv; Tuğba ÇAM YANIK (Other Identifier: Mersin University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No