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

No phase Interventional Anxiety Fear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: stress ball.
Who it may be relevant to
Registry conditions: Anxiety, Fear. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 appro

Primary outcome measures

  • Visual Analog Scale for Anxiety (VAS-A) [Time frame: Before the stress ball application, immediately after, and 15 minutes after the intervention]
Secondary outcome measures (6)
  • Surgical Fear Scale [Time frame: Before the stress ball application, immediately after, and 15 minutes after the intervention]
  • Systolic blood pressure changes after stress ball [Time frame: Before the stress ball application, immediately after, and 15 minutes after the intervention]
  • Diastolic blood pressure changes after stress ball [Time frame: Before the stress ball application, immediately after, and 15 minutes after the intervention]
  • Heart rate changes after stress ball [Time frame: Before the stress ball application, immediately after, and 15 minutes after the intervention]
  • Respiratory rate changes after stress ball [Time frame: Before the stress ball application, immediately after, and 15 minutes after the intervention]
  • Oxygen saturation values changes after stress ball [Time frame: Before the stress ball application, immediately after, and 15 minutes after the intervention]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Turkey, Mersin University, — Yenişehir

Identifiers

NCT: NCT07507656 · Mersin_Unıve · Tuğba ÇAM YANIK

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗