About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are scheduled to undergo Retrograde Intrarenal Surgery (RIRS),
Are 18 years of age or older,
Are conscious and cooperative,
Speak and understand Turkish,
Disqualifiers
Are under 18 years of age,
Are not conscious or cooperative,
Do not speak or understand Turkish,
Have unstable general condition or hemodynamic parameters,
Trial design
Parallel
Treatments tested in this trial
stress ball
Other interventionAfter 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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.
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.
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.
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