NCT07507656

The Effect of a Stress Ball Applied Before Retrograde Intrarenal Surgery on Anxiety, Surgical Fear, and Hemodynamic Parameters

The Effect of a Stress Ball Applied Before Retrograde Intrarenal Surgery on Anxiety, Surgical Fear, and Hemodynamic Parameters: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Mersin University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was designed as a randomized controlled trial to determine the effect of a stress ball applied before retrograde intrarenal surgery on patients' anxiety levels, surgical fear, and hemodynamic parameters.

Detailed description

Retrograde intrarenal surgery (RIRS), a minimally invasive surgical procedure, is widely used in the treatment of kidney stones. Although RIRS is considered a minimally invasive intervention, patients may still experience significant levels of anxiety and surgical fear in the preoperative period due to the diagnostic and treatment process. These preoperative responses may lead to changes in hemodynamic parameters such as heart rate, respiratory rate, and blood pressure through activation of the sympathetic nervous system . Increased anxiety levels may negatively affect patients' adaptation to the surgical process and may also increase the risk of perioperative complications . In addition, preoperative surgical fear may adversely affect anxiety levels in the postoperative period . Surgical fear and anxiety are among the important factors that increase patients' perception of pain and negatively affect the perioperative process. Anxiety that cannot be controlled in the preoperative period may lead to negative outcomes in terms of postoperative pain, analgesic requirements, and the recovery process. Therefore, managing anxiety and surgical fear before surgery is crucial for improving patient safety and the quality of care. Non-pharmacological methods are effective in managing preoperative anxiety. However, pharmacological approaches may have limitations such as sedation, risk of side effects, and additional costs. In recent years, to reduce these limitations, distraction-based non-pharmacological methods have been increasingly used in urological and other surgical procedures. These methods include interventions such as music therapy (in urological surgeries) and stress ball use (in procedures such as cataract surgery and angiography).The use of a stress ball is a method that enables rhythmic activation of hand muscles. As a non-pharmacological intervention, it is a simple, safe, practical, and up-to-date approach that helps divert the individual's attention away from anxiety-provoking stimuli. The literature reports that the use of stress balls before and during various invasive and surgical procedures reduces anxiety, pain, and surgical fear, and helps maintain stability in hemodynamic parameters such as heart rate and blood pressure. Recent randomized controlled trials conducted in procedures such as cholecystectomy, angiography, cataract surgery, and day-case surgeries have demonstrated that stress ball application has positive effects on patient outcomes (pain, anxiety, or comfort). In the study by Alptekin et al., it was found that the stress ball applied before cystectomy significantly reduced anxiety levels and surgical fear scores compared to the control group (p\<0.05). Similarly, in patients undergoing cataract surgery, stress ball use was reported to reduce pain and anxiety and significantly decrease pulse and respiratory rate.Although studies focusing specifically on the preoperative period of RIRS are limited, it is known that preoperative anxiety and surgical fear are common in urological surgeries and may lead to changes in hemodynamic variables. In this context, evaluating the effectiveness of an easily applicable method such as a stress ball in the preoperative period of RIRS is expected to fill an important gap in the literature. To the best of our knowledge, no study has been found examining the effects of stress ball application before RIRS on anxiety, surgical fear, and hemodynamic variables.

Conditions

• Anxiety
• Fear

Interventions

Type	Name	Description
OTHER	stress ball	After completing the data collection form, participants in the intervention group will undergo the stress ball application conducted by T.Ç.Y. and N.B. In addition to the clinic's routine treatment and care procedures, patients in the intervention group will be briefly instructed and shown how to use the stress ball approximately 45 minutes before leaving the clinic. The stress ball application will last for approximately 15 minutes. A round, medium-firm, high-quality silicone ball with an approximate diameter of 6 cm will be used. Patients will be instructed to hold the ball in their palms, count to three, squeeze it once, and then release it. They will be asked to continue this procedure for 15 minutes while focusing their attention on the stress ball. After each use, the ball will be washed and cleaned, and before being handed to the patient, it will be wiped with disposable aseptic wipes.

Timeline

• Start date: 2026-04-16
• Primary completion: 2026-04-16
• Completion: 2027-04-16
• First posted: 2026-04-02
• Last updated: 2026-04-08

Locations

1 site across 1 country: Turkey (Türkiye)