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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Fear
• Intervention / Treatment: Other: stress ball

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tuğba ÇAM 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:

Patients to be included in the study are those who:

• Are scheduled to undergo Retrograde Intrarenal Surgery (RIRS),
• Are 18 years of age or older,
• Are conscious and cooperative,
• Speak and understand Turkish,
• Have stable general condition and hemodynamic parameters,
• Are scheduled for an elective surgical procedure,
• Have no psychiatric diagnosis,
• Are not using psychiatric and/or local neuromuscular blocking medications,
• Provide informed consent to participate in the study (have signed the Informed Consent Form).

Exclusion Criteria:

Patients who will not be included in the study are those who:

• Are under 18 years of age,
• Are not conscious or cooperative,
• Do not speak or understand Turkish,
• Have unstable general condition or hemodynamic parameters,
• Are undergoing emergency surgical procedures,
• Have an existing psychiatric diagnosis,
• Are using psychiatric and/or local neuromuscular blocking medications,
• Do not consent to participate in the study (have not signed 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
No Intervention: control; All patients in the control group will undergo their initial assessments 45 minutes before the surgical procedure. In alignment with the timing of the intervention group (considering that the stress ball application will be administered for 15 minutes), the VAS-A, Surgical Fear, and hemodynamic parameters will be reassessed at 15 and 30 minutes after the initial evaluation.
Experimental: stress ball; Initial assessments of the patients will be performed approximately 45 minutes before leaving the clinic. The VAS-A, Surgical Fear, and hemodynamic parameters of the intervention group will be reassessed immediately after the stress ball application (15 minutes after the initial assessment) and 15 minutes after the completion of the intervention (30 minutes after the initial assessment).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 the stress ball application, immediately after, and 15 minutes after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Fear Scale	The Surgical Fear Scale (SFS) was developed by Theunissen et al. in 2014 to determine the level of fear related to the short- and long-term consequences of surgical procedures in patients undergoing elective surgery . Its Turkish validity and reliability were established by Bağdigen and Özlü in 2018. The scale consists of 8 items scored on an 11-point Likert scale ranging from 0 to 10, where 0 indicates "not at all afraid" and 10 indicates "very afraid." The scale has two subdimensions, each comprising four items, representing fear related to the short-term and long-term consequences of surgery. Items 1-4 measure fear of the short-term consequences, while items 5-8 measure fear of the long-term consequences of surgery. Subscale scores are obtained by summing the scores of the four items in each subdimension, and the total scale score is calculated by summing the two subscale scores. Total scores can range from 0 to 80, and subscale scores from 0 to 40. Higher scores	Before the stress ball application, immediately after, and 15 minutes after the intervention
Systolic blood pressure changes after stress ball	This form will record the systolic blood pressure values of the study and control groups measured at the specified times.Systolic blood pressure 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 the stress ball application, immediately after, and 15 minutes after the intervention
Diastolic blood pressure changes after stress ball	This form will record the diastolic blood pressure values of the study and control groups measured at the specified times. Diastolic blood pressure 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 the stress ball application, immediately after, and 15 minutes after the intervention
Heart rate changes after stress ball	This form will record the heart rate values of the study and control groups measured at the specified times. Heart rate 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 the stress ball application, immediately after, and 15 minutes after the intervention
Respiratory rate changes after stress ball	This form will record respiratory rate values of the study and control groups measured at the specified times. Respiratory rate 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 the stress ball application, immediately after, and 15 minutes after the intervention
Oxygen saturation values changes after stress ball	This form will record the oxygen saturation values of the study and control groups measured at the specified times. Oxygen saturation 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 the stress ball application, immediately after, and 15 minutes after the intervention

Collaborators and Investigators

• Sponsor: Mersin University

Study record dates

Study Major Dates

• Study Start (Estimated): April 16, 2026
• Primary Completion (Estimated): April 16, 2026
• Study Completion (Estimated): April 16, 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 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: anxiety; hemodynamic parameters; Retrograde intrarenal surgery; stress ball; surgical fear
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Mersin_Unıve; Tuğba ÇAM YANIK (Other Identifier: Mersin University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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