CompletedNot Applicable

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

Turkey (Türkiye)64 participantsStarted 2025-05-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain level

Timeframe: Up to six weeks

Anxiety level

Timeframe: Up to six weeks

Trial details

NCT IDNCT06846723

SponsorMersin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-01

View on ClinicalTrials.gov More Urolithiasis trials