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

NCT06846723 | Completed

• 1 other identifier: MersinUESWL
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis; Extracorporeal Shock Wave Lithotripsy

Keywords

stress ball; urolithiasis; ESWL; pain; anxiety

Outcome Measures

Primary Outcomes (2)

• Pain level

  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

  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 Outcomes (2)

• Satisfaction level

  Up to six weeks

• Continuity of treatment

  Up to six weeks

Study Arms (2)

Stress ball group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Stress ball 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.

Stress ball group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who agreed to participate in the study and whose verbal and written consent was obtained,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Yenişehir, 33010, Turkey (Türkiye)

Location

Related Publications (9)

• Browne C, Redmond E, Kelly T, Rogers E, O'Malley P, Nusrat N, Jaffry S, Durkan G, Walsh K, Dowling C, D'Arcy FT. Strategies to maximise patient comfort during extracorporeal shockwave lithotripsy - A randomised controlled trial. Surgeon. 2021 Aug;19(4):207-211. doi: 10.1016/j.surge.2020.07.002. Epub 2020 Aug 6.

  PMID: 32771299 RESULT

• 13. Torki, M., Heidari, H., Norian, K., Rabieie, L., & Sedehi, M. (2022). The effect of the distraction of thought by music on pain relief in patients undergoing extracorporeal shock wave lithotripsy: A randomized controlled trial. Journal of Shahrekord University of Medical Sciences, 24(2), 100-103.

  RESULT

• Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783.

  PMID: 30027283 RESULT

• Ugras GA, Kanat C, Yaman Z, Yilmaz M, Turkmenoglu MO. The Effects of Virtual Reality on Preoperative Anxiety in Patients Undergoing Colorectal and Abdominal Wall Surgery: A Randomized Controlled Trial. J Perianesth Nurs. 2023 Apr;38(2):277-283. doi: 10.1016/j.jopan.2022.07.005. Epub 2022 Oct 29.

  PMID: 36319521 RESULT

• Duzel B, Cam Yanik T, Kanat C, Altun Ugras G. The effect of acupressure on pain level and hemodynamic parameters after coronary angiography: a randomized controlled study. Front Cardiovasc Med. 2023 Jul 14;10:1173363. doi: 10.3389/fcvm.2023.1173363. eCollection 2023.

  PMID: 37522084 RESULT

• Lei M, Li G, Tang Y, Yuan J, Yang T, Gao Z. Efficacy of music therapy for pain control of extracorporeal shock wave lithotripsy: A meta-analysis of randomized controlled studies. Medicine (Baltimore). 2024 May 31;103(22):e38182. doi: 10.1097/MD.0000000000038182.

  PMID: 39259054 RESULT

• Sokouti M, Sokouti M, Sokouti B. A systematic review and meta-analysis on the outcomes of extracorporeal shock wave compared to ureteroscopic lithotripsy for the treatment of ureteral stones. J Taibah Univ Med Sci. 2023 Jun 14;18(6):1459-1471. doi: 10.1016/j.jtumed.2023.06.001. eCollection 2023 Dec.

  PMID: 37441243 RESULT

• Gezginci E, Iyigun E, Yalcin S, Bedir S, Ozgok IY. Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety during Extracorporeal Shock Wave Lithotripsy: A Randomized Controlled Trial. Pain Manag Nurs. 2018 Jun;19(3):295-302. doi: 10.1016/j.pmn.2017.09.005. Epub 2017 Dec 14.

  PMID: 29248604 RESULT

• Chen HT, Hung KC, Hsu YC, Kuo JR, Chang YJ, Chen IW, Sun CK. Efficacy of acupuncture for pain relief in patients receiving extracorporeal shock wave lithotripsy: a meta-analysis of randomized controlled studies. Front Med (Lausanne). 2023 Jun 2;10:1114485. doi: 10.3389/fmed.2023.1114485. eCollection 2023.

  PMID: 37332744 RESULT

MeSH Terms

Conditions

Urolithiasis; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Department of Surgical Diseases Nursing, Principal investigator, Research assistant

Model Details: Prospective, parallel, two-arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 26, 2025
• Study Start: May 28, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 30, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)