An interventional study of stress ball in Anxiety and Fear, sponsored by Mersin University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Mersin University · Not applicable, Interventional, and Supportive care
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.
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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 66 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Mersin University is the lead sponsor of 181 studies on the registry; 48 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients to be included in the study are those who:
Exclusion Criteria:
Patients who will not be included in the study are those who:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: Before the stress ball application, immediately after, and 15 minutes after the intervention
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before the stress ball application, immediately after, and 15 minutes after the intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2026 to primary completion in Apr 2026, 0 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 0 months is below that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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