AnxietyStressballNCT07507656
The Effect of a Stress Ball Applied Before Retrograde Intrarenal Surgery
A study testing stress ball in people with Anxiety and Fear, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2026to 16 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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).
Who cannot join
- 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,
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mersin University
Mersin, Mersin, 33343
Tuğba ÇAM YANIK, 05067703216, tugbacam@mersin.edu.tr
About this study
Official title: 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.
Read the 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.
- Being tested
- stress ball
- Keywords
- Retrograde intrarenal surgery, stress ball, anxiety, surgical fear, hemodynamic parameters
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ballOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: stress ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the stress ball application, immediately after, and 15 minutes after the intervention
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before the stress ball application, immediately after, and 15 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start16 Apr 2026
- Primary completion16 Apr 2026
- Study completion16 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba CAM YANIK, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507656
- Sponsor's protocol ID
- Mersin_Unıve
- Other IDs
- Tuğba ÇAM YANIK
- Acronym
- Stressball
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Stress Ball Applied Before Retrograde Intrarenal Surgery on Anxiety, Surgical Fear, and Hemodynamic Parameters: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07507656
- Acronym / sponsor ID
- Stressball / Mersin_Unıve
- Keywords
- Retrograde intrarenal surgery, stress ball, anxiety, surgical fear, hemodynamic parameters
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2027 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: stress ballInitial 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress ballAfter 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. | Other | stress ball |
Primary outcome
Visual Analog Scale for Anxiety (VAS-A)
Time frame: Before the stress ball application, immediately after, and 15 minutes after the intervention
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress ball in people with Anxiety and Fear, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğba ÇAM YANIK, PHD (+905067703216, tugbacam@mersin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Anxiety (VAS-A) (time frame: Before the stress ball application, immediately after, and 15 minutes after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.