Clinical trial NCT06846723: Stress Ball Effects to Pain, Anxiety, Satisfaction and Treatment Continuity During ESWL
Official title: The Effect of Stress Ball on Pain, Anxiety, Satisfaction and Treatment Continuity in Patıents With Extracorporeal Shock Wave Lithotripsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urolithiasis
Extracorporeal Shock Wave Lithotripsy
Keywords: stress ball
urolithiasis
ESWL
pain
anxiety
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, two-arm, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain level
timeFrame: Up to six weeks
measure: Anxiety level
timeFrame: Up to six weeks
Secondary outcomes:
measure: Satisfaction level
timeFrame: Up to six weeks
measure: Continuity of treatment
timeFrame: Up to six weeks
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
state: Yenişehir
Study officials:
References:
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