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

NCT07507656 | Not Yet Recruiting DMC

• 2 other identifiers: Mersin_UnıveTuğba ÇAM YANIK
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Fear

Keywords

Retrograde intrarenal surgery; stress ball; anxiety; surgical fear; hemodynamic parameters

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Surgical Fear Scale

  Before the stress ball application, immediately after, and 15 minutes after the intervention

• Systolic blood pressure changes after stress ball

  Before the stress ball application, immediately after, and 15 minutes after the intervention

• Diastolic blood pressure changes after stress ball

  Before the stress ball application, immediately after, and 15 minutes after the intervention

• Heart rate changes after stress ball

  Before the stress ball application, immediately after, and 15 minutes after the intervention

• Respiratory rate changes after stress ball

  Before the stress ball application, immediately after, and 15 minutes after the intervention

Study Arms (2)

control

NO INTERVENTION

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.

stress ball

EXPERIMENTAL

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

Interventions

stress ball OTHER

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.

stress ball

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Turkey, Mersin University,

Yenişehir, Mersin, 33120, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Tuğba ÇAM YANIK, PHD

CONTACT

+905067703216; tugbacam@mersin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgical Diseases Nursing

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: April 16, 2026
• Primary Completion: April 16, 2026
• Study Completion (Estimated): April 16, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)