Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy

NCT02725281 | Completed

• 1 other identifier: 50687469-1491-85-14/1648.4-464
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Urinary Tract Stones; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• A change on anxiety level in STAI-SA (State-Trait Anxiety Inventory-State Anxiety) at the end of procedure compared with the baseline

  5 min before and 5 min after the ESWL process

Study Arms (3)

Control group

NO INTERVENTION

The patients in "Group 1" didn't receive any intervention during ESWL.

Stress ball

ACTIVE COMPARATOR

The patients in "Group 2" were given stress ball into both their palms 5 minutes before ESWL. Participants were instructed to "squeeze the balls twice after counting up to ten" and "repeat it until the end of the procedure". This ball was medium hard and it was made of high quality silicon.

Other: Stress ball

Music

ACTIVE COMPARATOR

The patients in "Group 3" were listened to the music chosen by them with a headset as a nonpharmacological method during lithotripsy.

Other: Music

Interventions

Stress ball OTHER

The patients in this group were given stress ball into both their palms 5 minutes before ESWL. Participants were instructed to "squeeze the balls twice after counting up to ten" and "repeat it until the end of the procedure". This ball was medium hard and has been made of high quality silicon.

Stress ball

Music OTHER

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.

Music

Eligibility Criteria

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

You may qualify if:

• 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 renal colic just before ESWL,
• Not to have any contraindication in terms of lithotripsy,
• Not to have ureteral stent.

You may not qualify if:

• To refuse to participate in this study,

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Related 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;2012(5):CD006029. doi: 10.1002/14651858.CD006029.pub4.

  PMID: 22592707 BACKGROUND

• 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.

  PMID: 24892029 BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1016/s0885-3924(98)00099-2.

  PMID: 9879163 BACKGROUND

• Coll AM, Ameen JR, Mead D. Postoperative pain assessment tools in day surgery: literature review. J Adv Nurs. 2004 Apr;46(2):124-33. doi: 10.1111/j.1365-2648.2003.02972.x.

  PMID: 15056325 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.3126/kumj.v12i1.13639.

  PMID: 25219995 BACKGROUND

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

  BACKGROUND

• 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. doi: 10.1067/mge.2002.120387.

  PMID: 11756911 BACKGROUND

• 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.

  PMID: 24648110 BACKGROUND

• Öner, N., & Le Compte, A. (1985). Durumluk/Sürekli Kaygi Envanteri El Kitabı. (State-Trait Anxiety Inventory Handbook) 2. Baskı, Boğaziçi Üniversitesi Yayınları, Istanbul No:333, 52-56.

  BACKGROUND

• 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.

  PMID: 24602425 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1007/s00240-005-0473-7. Epub 2005 Jun 22.

  PMID: 15971087 BACKGROUND

• Salinas AS, Lorenzo-Romero J, Segura M, Calero MR, Hernandez-Millan I, Martinez-Martin M, Virseda JA. Factors determining analgesic and sedative drug requirements during extracorporeal shock wave lithotripsy. Urol Int. 1999;63(2):92-101. doi: 10.1159/000030425.

  PMID: 10592496 BACKGROUND

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

  PMID: 20705199 BACKGROUND

• Stevensen C. Non-pharmacological aspects of acute pain management. Complement Ther Nurs Midwifery. 1995 Jun;1(3):77-84. doi: 10.1016/s1353-6117(05)80081-2.

  PMID: 9456714 BACKGROUND

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

  BACKGROUND

• 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. doi: 10.1089/acm.2006.6262.

  PMID: 17388767 BACKGROUND

• Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.

  PMID: 16000093 BACKGROUND

• 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. doi: 10.1016/s0090-4295(02)02375-0.

  PMID: 12597931 BACKGROUND

MeSH Terms

Conditions

Urinary Calculi; Pain; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elif Gezginci, RN,PhDs

  Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

  PRINCIPAL INVESTIGATOR

• Emine Iyigun, RN,AssocProf

  Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

  STUDY DIRECTOR

• Serdar Yalcin, MD

  Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

  PRINCIPAL INVESTIGATOR

• Selahattin Bedir, MD,Prof

  Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

  STUDY DIRECTOR

• Yasar I. Ozgok, MD,Prof

  Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, Msc, PhDs

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 31, 2016
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 3, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share