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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-28

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urolithiasis Extracorporeal Shock Wave Lithotripsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel, two-arm, randomized controlled clinical trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

According to the randomization table, the information showing the patients included in the research sample is assigned to the A and B groups will be put in an opaque envelope. This envelope will be kept by the coordinator researcher (GAU) and when the researcher (CK) goes to the patient for application, after filling out the "Informed Voluntary Consent Form", he will open the envelope and learn which group is in which group. Due to the nature of the study, patients and the researcher (CK) will not be blinded, since stress ball will be applied only to the patients included in the study. However, the researcher (EC) collecting the data will be blinded as he/she does not know which group the patients are in. When the research is completed, the data will be transferred to the computer environment by a statistician who does not know the A and B groups, and the data will be analyzed by a statistician independent of the research and the findings will be reported.

Study Groups

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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.

Group Type EXPERIMENTAL

Stress ball

Intervention Type OTHER

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.

Control group

The control group will be received routine treatment and care in the unit.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No