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

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.

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).

In this study, participants cannot be blinded because only patients in the intervention group will receive the application. Upon completion of the study, the data of the intervention and control groups (coded as A or B) will be transferred to a computer by an independent researcher. The data will then be analyzed and reported by a statistician using a blinded approach. Therefore, the study will be conducted as a single-blind clinical trial.