Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy

Pain Clinical Trial

Official title:

Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725281
• Other study ID #: 50687469-1491-85-14/1648.4-464
• Status: Completed
• Phase: N/A
• First received: March 14, 2016
• Last updated: March 27, 2016
• Start date: April 2014
• Est. completion date: September 2014

Study information

• Verified date: March 2016
• Source: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators observed that during the Extracorporeal Shock Wave Lithotripsy (ESWL) non-pharmacological methods used for reducing the level of the pain and anxiety among the patients with the urinary stones are not sufficient and the effectiveness of these methods is controversial. There are very few studies, which investigated the effects of music on the pain and anxiety during ESWL. In addition, any randomized clinical trial related to the use of stress ball for relaxation and distraction on the reduction of pain and anxiety during lithotripsy has not been found in the relevant literature. Investigators also evaluated that further evidence-based studies are necessary. Thus, investigators aimed to investigate the effectiveness of stress ball and music for reducing the pain and anxiety of the patients during ESWL in this study.

Description:

Extracorporeal Shock Wave Lithotripsy (ESWL), used commonly in urinary stone treatment, can cause pain and anxiety for patients. The aim of this study was to investigate the efficacy of use of music and stress ball to reduce pain and anxiety during lithotripsy. This was a single center parallel-randomized controlled trial. The study sample consisted of a total of 120 patients who applied to lithotripsy unit of urology clinic in a training and research hospital in Turkey between April and September 2014. The patients were randomly divided into three groups. The patients in group-I (control group) were not interfered, while group-II was given stress ball into their palms in order to squeeze and group-III was listened to the music chosen by themselves with a headset during the lithotripsy procedure. Data were collected using the Patient Information Form, Visual Analogue Scale (VAS), and State Trait Anxiety Inventory (STAI-SA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The inclusion criteria of this study were to have kidney or ureter stones eligible for the ESWL procedure based on the European Association of Urology Guideline,

• To be the first lithotripsy treatment,

• To be older than 18 years old,

• To have the body mass index of 30kg/m2 or less,

• Not to be given analgesic before the procedure,

• Not to have pain at the time of ESWL,

• Not to have any contraindication in terms of lithotripsy,

• Not to have double J ureteral catheter.

Exclusion Criteria:

• To refuse to participate in this study,

• Not to meet the inclusion criteria.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Urinary Calculi
• Urinary Tract Stones

Intervention

Other:
• Stress ball
The patients in this group were given stress ball into their both palms 5 min before the lithotripsy and told to squeeze the ball whenever they would like until end of the process. This ball was medium hard and has been made of high quality silicon.
• Music
The patients in this group were also listened to the music chosen by them with a headset from 5 min before until the end of lithotripsy. Types of music played for the patients were Turkish folk music, Turkish art music, Turkish arabesque music, Turkish pop music, foreign pop music, rock music, and classical music.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

References & Publications (23)

Aboumarzouk OM, Kata SG, Keeley FX, McClinton S, Nabi G. Extracorporeal shock wave lithotripsy (ESWL) versus ureteroscopic management for ureteric calculi. Cochrane Database Syst Rev. 2012 May 16;(5):CD006029. doi: 10.1002/14651858.CD006029.pub4. Review. — View Citation

Akin Y, Yucel S. Long-term effects of pediatric extracorporeal shockwave lithotripsy on renal function. Res Rep Urol. 2014 Apr 28;6:21-5. doi: 10.2147/RRU.S40965. eCollection 2014. Review. — View Citation

Bosio, A., Destefanis, P., Buffardi, A., Alessandria, E., Dalmasso, E., Lucci Chiarissi, M., Berta, G., Bisconti, A., Fontana, D., & Frea, B. E68 Does music reduce discomfort during ESWL? A prospective randomized trial. European Urology Supplements, 2013 3;12:53.

Cepeda MS, Diaz JE, Hernandez V, Daza E, Carr DB. Music does not reduce alfentanil requirement during patient-controlled analgesia (PCA) use in extracorporeal shock wave lithotripsy for renal stones. J Pain Symptom Manage. 1998 Dec;16(6):382-7. — View Citation

Coll AM, Ameen JR, Mead D. Postoperative pain assessment tools in day surgery: literature review. J Adv Nurs. 2004 Apr;46(2):124-33. Review. — View Citation

Demir, Y. (2012). Non-pharmacological therapies in pain management. INTECH Open Access Publisher.

Diana, K.J., & George, K.V. (2013). Urinary stone formation: Efficacy of seed extract of Ensete superbum (Roxb.) Cheesman on growth inhibition of calcium hydrogen phosphate dihydrate crystals. Journal of Crystal Growth, 363, 164-170.

Joshi HN, Karmacharya RM, Shrestha R, Shrestha B, de Jong IJ, Shrestha RK. Outcomes of extra corporeal shock wave lithotripsy in renal and ureteral calculi. Kathmandu Univ Med J (KUMJ). 2014 Jan-Mar;12(45):51-4. — View Citation

Karabulut, N., Gürçayir, D., & Aktas, Y.Y. (2015). Non-pharmacological interventions for pain management used by nursing students in Turkey. Kontakt.

Lee DW, Chan KW, Poon CM, Ko CW, Chan KH, Sin KS, Sze TS, Chan AC. Relaxation music decreases the dose of patient-controlled sedation during colonoscopy: a prospective randomized controlled trial. Gastrointest Endosc. 2002 Jan;55(1):33-6. — View Citation

Ngee-Ming G, Tamsin D, Rai BP, Somani BK. Complementary approaches to decreasing discomfort during shockwave lithotripsy (SWL). Urolithiasis. 2014 Jun;42(3):189-93. doi: 10.1007/s00240-014-0655-2. Epub 2014 Mar 20. Review. — View Citation

Öner, N., & Le Compte, A. (1985). Durumluk/Sürekli Kaygi Envanteri El Kitabi. (State-Trait Anxiety Inventory Handbook) 2. Baski, Bogaziçi Üniversitesi Yayinlari, Istanbul No:333, 52-56.

Ozsaker E, Diramali A. The effect of transcutaneous electrical nerve stimulation for pain relief during extracorporeal shock-wave lithotripsy procedure. Pain Manag Nurs. 2014 Mar;15(1):59-68. doi: 10.1016/j.pmn.2012.06.003. Epub 2012 Aug 18. — View Citation

Pearle, M.S., & Lotan, Y. (2012). Urinary lithiasis: etiology, epidemiology, and pathogenesis. Camphel-walsh Urology, 10, 1257-1286.

Perera, N.D., & Perera S.J. (2013). The role of extracorporeal shock wave lithotripsy in renal calculi. Sri Lanka Journal of Surgery, 31(3), 33-40.

Resim S, Gumusalan Y, Ekerbicer HC, Sahin MA, Sahinkanat T. Effectiveness of electro-acupuncture compared to sedo-analgesics in relieving pain during shockwave lithotripsy. Urol Res. 2005 Aug;33(4):285-90. Epub 2005 Jun 22. — View Citation

Salinas AS, Lorenzo-Romero J, Segura M, Calero MR, Hernández-Millán I, Martínez-Martín M, Virseda JA. Factors determining analgesic and sedative drug requirements during extracorporeal shock wave lithotripsy. Urol Int. 1999;63(2):92-101. — View Citation

Schade GR, Faerber GJ. Urinary tract stones. Prim Care. 2010 Sep;37(3):565-81, ix. doi: 10.1016/j.pop.2010.05.003. Review. — View Citation

Stevensen C. Non-pharmacological aspects of acute pain management. Complement Ther Nurs Midwifery. 1995 Jun;1(3):77-84. Review. — View Citation

Turk, C., Knoll, T., Petrik, A., Sarica, K., Skolarikos, A., Straub, M., & Seitz, C. (2014). Guidelines on urolithiasis. European Association of Urology.

Wang SM, Punjala M, Weiss D, Anderson K, Kain ZN. Acupuncture as an adjunct for sedation during lithotripsy. J Altern Complement Med. 2007 Mar;13(2):241-6. — View Citation

Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. Review. — View Citation

Yilmaz E, Ozcan S, Basar M, Basar H, Batislam E, Ferhat M. Music decreases anxiety and provides sedation in extracorporeal shock wave lithotripsy. Urology. 2003 Feb;61(2):282-6. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change on pain severity in VAS (Visual Analogue Scale) pain scale reported by the patients at the end of lithotripsy procedure compared with the baseline	Pain	5 min before and 5 min after the ESWL process
Secondary	A change on anxiety level in STAI-SA (State-Trait Anxiety Inventory-State Anxiety) at the end of procedure compared with the baseline	Anxiety	5 min before and 5 min after the ESWL process