Stress Ball Effects to Pain, Anxiety, Satisfaction and Treatment Continuity During ESWL

May 13, 2026 updated by: Canan KANAT, Mersin University

The Effect of Stress Ball on Pain, Anxiety, Satisfaction and Treatment Continuity in Patıents With Extracorporeal Shock Wave Lithotripsy

Extracorporeal shock wave lithotripsy (ESWL), a minimally invasive procedure, is used in the treatment of urolithiasis. The shock waves used in this procedure, which does not require any incision, cause pain in the superficial structures of the body such as skin, muscles and deep structures such as costae, nerves and kidney tissue. This pain may cause patients not to tolerate the treatment, delay in recovery, decrease in the effectiveness of the treatment and decrease in satisfaction. Patients may also experience anxiety about the procedure prior to treatment. Anxious patients experience more pain during ESWL. Pain and anxiety increase the activation of the sympathetic nervous system and neuroendocrine response, leading to physiologic changes such as increased blood pressure, heart rate and oxygen requirement of the body. This may negatively affect the vital signs of the patients. Therefore, it is essential to relieve pain and anxiety in patients undergoing ESWL and pharmacologic and nonpharmacologic methods are used for this purpose. Pharmacologic methods such as analgesics, opioids and sedative agents are used to reduce pain and anxiety in patients. Since these methods have side effects such as nausea, vomiting, gastric bleeding, respiratory depression, tachycardia, constipation, the use of non-pharmacological methods that can be applied by nurses is increasing. One of the non-pharmacologic methods is the stress ball, which uses the sense of touch to divert attention with cognitive focus. In this simple, reliable, cheap and easily accessible method, pain and anxiety are reduced by directing the mind to the attention-grabbing stimulus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Urolithiasis, which affects more than 12% of the world population and is one of the most common diseases of the urinary system, is diagnosed with pain, urinary tract infection, hydronephrosis, colicky pain, hematuria, nausea, vomiting, fever and chills, foul-smelling and cloudy urine as a result of stone obstruction of the ureter. Extracorporeal shock wave lithotripsy (ESWL), which is a highly minimally invasive procedure, is used in the treatment of urolithiasis in case of failure of medical treatments. This method is particularly effective for renal stones smaller than 2 cm and located in the upper ureter; however, it is also frequently preferred before surgical intervention due to its noninvasiveness and low morbidity.

In extracorporeal shock wave lithotripsy, high-energy shock waves are used to break the stone into small pieces that can rapidly pass through the ureters. The shock waves used in this procedure, which does not require any incision, cause pain in superficial structures of the body such as skin, muscle and deep structures such as costae, nerves and renal tissue. This pain may cause patients not to tolerate the treatment, delay in recovery, decrease in the effectiveness of the treatment and decrease in satisfaction. In addition, patients may experience anxiety about the procedure to be performed before treatment. Patients who experience anxiety experience more pain during ESWL.

Pain and anxiety increase the activation of the sympathetic nervous system and neuroendocrine response, leading to physiologic changes such as increased blood pressure, heart rate and oxygen requirement of the body. This may negatively affect the vital signs of patients. Therefore, it is essential to eliminate pain and anxiety in patients undergoing ESWL and pharmacologic and nonpharmacologic methods are used for this purpose. Pharmacologic methods such as analgesics, opioids and sedative agents are used to reduce pain and anxiety in patients. Since these methods have side effects such as nausea, vomiting, gastric bleeding, respiratory depression, tachycardia, and constipation, the use of non-pharmacologic methods that can be applied by nurses is increasing. Stress ball, which is one of the non-pharmacologic methods, provides diversion of attention with cognitive focusing by using the sense of touch. In this simple, reliable, inexpensive and easily accessible method, pain and anxiety are reduced by directing the mind to the attention-grabbing stimulus. In the literature, studies evaluating the effect of music on pain and anxiety in patients undergoing ESWL are common; however, only two studies evaluating the effect of stress ball were found. In these studies, the effects of two different non-pharmacologic methods, both stress ball and music, were examined; however, the effects on the satisfaction levels of the patients and their attendance to ESWL sessions were not examined. In the literature, it was reported that approximately 72-75% of patients underwent three or more ESWL sessions at 7-10 day intervals. However, inadequate management of patients' pain and anxiety may adversely affect their continuity of treatment and cause them to prefer surgical intervention instead of continuing ESWL sessions. Based on this information, in this study, it was aimed to examine the effect of stress ball on pain and anxiety in patients undergoing ESWL, as well as the effect of stress ball on patients' satisfaction levels and ESWL continuation status, unlike the literature. With the findings of the study, it is planned to contribute to the literature and to provide evidence for the importance of the use of non-pharmacologic methods.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Yenişehir
      • Mersin, Yenişehir, Turkey (Türkiye), 33010
        • Mersin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Those who agreed to participate in the study and whose verbal and written consent was obtained,
  • 18 years of age or older,
  • Can speak, read and write Turkish,
  • Does not have any cognitive, affective and verbal problems that prevent them from communicating,
  • Open to communication,
  • First time ESWL,
  • The first session of ESWL will be administered,
  • Body mass index <30 kg\m2,
  • Have not taken any analgesic before the procedure,
  • Not taking anticoagulants before the procedure,
  • Have not experienced renal colic pain immediately before the procedure,
  • Not pregnant,
  • Patients for whom ESWL is not contraindicated for any reason will be included in the study.

Exclusion Criteria:

  • No verbal or written authorization can be obtained,
  • Under 18 years of age,
  • They cannot speak, write or read Turkish,
  • Have any cognitive, affective and verbal problem that prevents them from communicating,
  • The one who is closed to communication,
  • Previously undergone ESWL,
  • You will undergo a second or more sessions of ESWL,
  • Body mass index >30 kg\m2,
  • Who has taken analgesics before the procedure,
  • Anticoagulants taken before the procedure,
  • Experiencing renal colic pain just before the procedure,
  • Pregnant,
  • Patients in whom ESWL is contraindicated will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group will be received routine treatment and care in the unit.
Experimental: Stress ball group
In addition to the routine treatment and care practices of the outpatient clinic, the patients included in the study group will be applied stress ball during ESWL.
Other: Stress ball
In addition to the routine treatment and care practices of the outpatient clinic, the patients included in the study group will be applied stress ball during ESWL. The researcher (CK) will explain and show the patients how to apply the stress ball 10 minutes before the procedure. The stress ball will be applied during the ESWL session and a round, medium-hard, high-quality silicone ball with an average diameter of 6 cm will be used. Patients will be asked to take the ball in the palm of their hand and squeeze and release the ball once after counting to three. Patients will be instructed to continue this practice until the end of the ESWL procedure and to pay attention to the stress ball during the procedure. The ball will be washed and cleaned after each use and wiped with disposable asepsis wipes before being given to the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: Up to six weeks
Visual Analog Scale (VAS) will be used to determine the pain intensity of patients during and after ESWL procedure. VAS was developed to convert some values that cannot be measured numerically into numerical form. The VAS, which is an easy-to-understand, quick-to-use scale that allows meaningful comparison of measurements over time, consists of a 10 cm long line with subjective descriptive statements at both ends of the scale. The patient will be asked to place a mark on this 10 cm line indicating the level of pain during and after the ESWL procedure (0=No pain, 10=Unbearable pain). The distance from the beginning of the scale to the mark will be measured with a ruler and the pain level of the individual will be determined numerically in cm. A low score obtained from the VAS will indicate that the pain intensity of the individual is low/low and a high score will indicate that the pain intensity is high.
Up to six weeks
Anxiety level
Time Frame: Up to six weeks
The State-Trait Anxiety scale, for which a Turkish validity-reliability study was conducted, will be used to determine anxiety levels before and after the procedure in patients undergoing ESWL. This scale was developed by Spielberger et al. in 1970 and can be applied to people over the age of 14. The scale consists of the State-Trait Anxiety Scale, which determines how the individual feels at a certain moment and condition, and the Trait Anxiety Scale, which determines how the individual feels regardless of the situation and condition. In the present study, the DAQ, which is structured to measure what is felt at that moment, will be used.
Up to six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuity of treatment
Time Frame: Up to six weeks
The attendance of the patients to the next sessions will be checked from the follow-up list of patients undergoing ESWL in the outpatient clinic where the study was conducted and recorded on this form.
Up to six weeks
Satisfaction level
Time Frame: Up to six weeks
After the ESWL procedure, the satisfaction level of the patients with the ESWL procedure and their attendance to the next sessions will be recorded. Visual Analog Scale (VAS) was developed to convert some values that cannot be measured numerically into numerical form. VAS, which is a safe, easily applicable measurement tool generally accepted in the world literature, consists of a 10 cm long line with subjective descriptive statements at both ends of the scale. The patient will be asked to place a mark on this 10 cm line indicating the level of satisfaction with the ESWL procedure (0=Not at all satisfied, 10=Very satisfied).
Up to six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2025

Primary Completion (Actual)

May 1, 2026

Study Completion (Actual)

May 10, 2026

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MersinUESWL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In order to avoid duplication, it is not intended to be shared until the research is completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urolithiasis

Clinical Trials on Stress ball

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe