The Effect of Hot-Cold Application to the Bladder After Orthopedic Surgery on Postoperative Urinary Retention
NCT ID: NCT05969145
Last Updated: 2024-01-31
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2023-11-15
2024-01-15
Brief Summary
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Detailed Description
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Postoperative urinary retention is a complication that manifests symptoms with problems such as suprapubic pain, bladder spasm, and/or inability to urinate after surgical treatment. The etiology of PUR includes factors caused by the patient (advanced age, male gender, anatomical problems, comorbidity, neural transmission disorders), due to the surgical process (failure to empty the bladder during the preoperative period, surgery lasts longer than 2 hours, emergency surgery, opioid-NSAID-atropine use, amount of fluid taken) and due to anesthesia (epidural/spinal anesthesia). 2-6 of the postoperative period. it gives symptoms as a result of the absence of the first urine decrement between hours. As a result, serious problems such as increased urinary pressure and acute kidney injury and/or dysfunction due to bladder distension occur in patients. Management of PUR can be achieved by using physical examination (globe monitoring), bladder catheterization, and ultrasonographic (USG) methods to diagnose these problems at an early stage.
Field health professionals, who have an important place in the conduct of health services, offer the greatest contribution to the surgical treatment process with their understanding of quality health care. In particular, nurses who are actively involved in the perioperative process are the professional staff with the greatest responsibility for positively managing health care. Nurses help to ensure the patient's comfort as soon as possible by providing multidisciplinary cooperation in the management of complications that develop during this process. For this purpose, nurses need to carry out the necessary practices and precautions against the risk of developing PUR, which is one of the postoperative complications. In the recently published Nursing Regulation, the nurses' authority to manage PUR is clearly stated as "interventions to be implemented by a nursing decision" as "A nurse can decide independently or jointly with a physician to insert and remove a urinary catheter if she cannot eliminate urinary retention with the interventions she can apply", "Hot-cold application" intervention definition is clearly stated. Therefore, nurses evaluate the patient by reviewing the existing risk factors of the patient and surgical process during the perioperative period, providing emotional support for surgical stress, questioning perioperative fluid intake, informing the patient about the consumption of caffeine-containing drinks and plenty of water, monitor urine postoperatively, prefer non-invasive methods (listening to water sound, relaxation, bladder massage, mobilization, hot-cold application, ko mot/duck/sliders) primarily in case of PURE development, and invasive methods as a last resort (urinary catheterization, ensuring the necessary cooperation with the physician for interventional applications is one of the important responsibilities in process management. In the literature, it is stated that hot-cold application with bladder catheterization, one of the invasive methods, and hot-water insertion of the hand, massage, mobilization, promotion of liquid and coffee consumption, pelvic muscle exercise, and acupuncture are used in the management of PUR. In the studies conducted, the first postoperative urine output time was reduced by sacral massage in the management of PUR nurses; there was a rapid and permanent decrease in the development of PUR accompanied by the urination algorithm from 21% to 3% observed. However, 59.5% of patients with a hot compress applied to the bladder and 71.4% with cold application had urinary retention regressed; a significant difference in the severity of urinary retention was revealed by hot application; it is reported that urinary catheterization after the hot application is applied to only 3.9% of the patients. Based on these results, it is seen that the practices used by nurses to prevent and manage PUR have resulted in positive outcomes; the hot and cold practice has also made significant contributions to PUR management. For this purpose, it is envisaged that our study will contribute to the effective management of hot-cold application of PUR to the bladder in orthopedic surgery patients, to the minimum preference of invasive applications, to increasing the awareness of nurses about PUR management, and to the literature.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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hot-cold application
This group will be given a hot cold application to the bladder
application of thermophor
The experimental group will be given hot and cold application to the bladder
control group
Routine clinical functioning will be applied to this group
No interventions assigned to this group
Interventions
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application of thermophor
The experimental group will be given hot and cold application to the bladder
Eligibility Criteria
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Inclusion Criteria
* no urinary catheter inserted during the perioperative process, conscious and orientated,
* no renal disease (chronic kidney failure, nephropathy, kidney transplantation, prostate, urinary tract infection, history of stones in the urinary system)
* voluntary acceptance to participate in the study.
Exclusion Criteria
* intellectual disability or perception problem,
* communication disability,
* renal disease (chronic kidney failure, nephropathy, kidney transplantation, prostate, urinary tract infection, history of stones in the urinary system)
18 Years
ALL
Yes
Sponsors
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Ankara Yildirim Beyazıt University
OTHER
Responsible Party
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Elif Demirden Erişti
Principal investigator
Principal Investigators
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Gulay Yazici
Role: STUDY_DIRECTOR
Assoc. Dr.
Locations
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Ankara Yildirim Beyazit University
Ankara, , Turkey (Türkiye)
Countries
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References
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Asahara H, Inui M, Lotz MK. Tendons and Ligaments: Connecting Developmental Biology to Musculoskeletal Disease Pathogenesis. J Bone Miner Res. 2017 Sep;32(9):1773-1782. doi: 10.1002/jbmr.3199. Epub 2017 Jul 13.
Lum ZC, Pereira GC, Giordani M, Meehan JP. Top 100 most cited articles in orthopaedic surgery: An update. J Orthop. 2019 Dec 2;19:132-137. doi: 10.1016/j.jor.2019.11.039. eCollection 2020 May-Jun.
Casari FA, Navab N, Hruby LA, Kriechling P, Nakamura R, Tori R, de Lourdes Dos Santos Nunes F, Queiroz MC, Furnstahl P, Farshad M. Augmented Reality in Orthopedic Surgery Is Emerging from Proof of Concept Towards Clinical Studies: a Literature Review Explaining the Technology and Current State of the Art. Curr Rev Musculoskelet Med. 2021 Apr;14(2):192-203. doi: 10.1007/s12178-021-09699-3. Epub 2021 Feb 5.
Parry SM, Puthucheary ZA. The impact of extended bed rest on the musculoskeletal system in the critical care environment. Extrem Physiol Med. 2015 Oct 9;4:16. doi: 10.1186/s13728-015-0036-7. eCollection 2015.
LeBoff MS, Greenspan SL, Insogna KL, Lewiecki EM, Saag KG, Singer AJ, Siris ES. The clinician's guide to prevention and treatment of osteoporosis. Osteoporos Int. 2022 Oct;33(10):2049-2102. doi: 10.1007/s00198-021-05900-y. Epub 2022 Apr 28.
Waljee J, Zhong L, Baser O, Yuce H, Fox DA, Chung KC. The incidence of upper and lower extremity surgery for rheumatoid arthritis among Medicare beneficiaries. J Bone Joint Surg Am. 2015 Mar 4;97(5):403-10. doi: 10.2106/JBJS.N.00802.
Franke A, Bieler D, Wilms A, Hentsch S, Johann M, Kollig E. [Treatment of gunshot fractures of the lower extremity: Part 2: Procedures for secondary reconstruction and treatment results]. Unfallchirurg. 2014 Nov;117(11):985-94. doi: 10.1007/s00113-014-2636-x. German.
Moosavi Tekye SM, Alipour M. Comparison of the effects and complications of unilateral spinal anesthesia versus standard spinal anesthesia in lower-limb orthopedic surgery. Braz J Anesthesiol. 2014 May-Jun;64(3):173-6. doi: 10.1016/j.bjane.2013.06.014. Epub 2013 Oct 25.
Fernandez MA, Karthikeyan S, Wyse M, Foguet P. The incidence of postoperative urinary retention in patients undergoing elective hip and knee arthroplasty. Ann R Coll Surg Engl. 2014 Sep;96(6):462-5. doi: 10.1308/003588414X13946184902523.
David M, Arthur E, Dhuck R, Hemmings E, Dunlop D. High rates of postoperative urinary retention following primary total hip replacement performed under combined general and spinal anaesthesia with intrathecal opiate. J Orthop. 2015 Nov 18;12(Suppl 2):S157-60. doi: 10.1016/j.jor.2015.10.020. eCollection 2015 Dec.
Scholten R, Kremers K, van de Groes SAW, Somford DM, Koeter S. Incidence and Risk Factors of Postoperative Urinary Retention and Bladder Catheterization in Patients Undergoing Fast-Track Total Joint Arthroplasty: A Prospective Observational Study on 371 Patients. J Arthroplasty. 2018 May;33(5):1546-1551. doi: 10.1016/j.arth.2017.12.001. Epub 2017 Dec 13.
Kort NP, Bemelmans Y, Vos R, Schotanus MGM. Low incidence of postoperative urinary retention with the use of a nurse-led bladder scan protocol after hip and knee arthroplasty: a retrospective cohort study. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):283-289. doi: 10.1007/s00590-017-2042-5. Epub 2017 Sep 12.
Abdul-Muhsin HM, Jakob N, Cha S, Zhang N, Schwartz A, Navaratnam A, Khan A, Humphreys M. Incidence, Outcomes, and Prediction of Postoperative Urinary Retention After a Nonurologic Procedure. J Am Acad Orthop Surg Glob Res Rev. 2020 May;4(5):e1900149. doi: 10.5435/JAAOSGlobal-D-19-00149.
Balderi T, Mistraletti G, D'Angelo E, Carli F. Incidence of postoperative urinary retention (POUR) after joint arthroplasty and management using ultrasound-guided bladder catheterization. Minerva Anestesiol. 2011 Nov;77(11):1050-7. Epub 2011 May 11.
Bjerregaard LS, Bogo S, Raaschou S, Troldborg C, Hornum U, Poulsen AM, Bagi P, Kehlet H. Incidence of and risk factors for postoperative urinary retention in fast-track hip and knee arthroplasty. Acta Orthop. 2015 Apr;86(2):183-8. doi: 10.3109/17453674.2014.972262. Epub 2014 Oct 10.
Lior Y, Haim S, Katz I, Danino B, Bar-Yosef Y, Ekstein M. Postoperative Urinary Catheterization in Children Treated with or without Epidural Analgesia after Orthopedic Surgery: A Retrospective Review of Practice. Children (Basel). 2022 Aug 29;9(9):1316. doi: 10.3390/children9091316.
Zelmanovich A, Fromer DL. (2018). Urinary Retention after Orthopedic Surgery: Identification of Risk Factors and Management. J Clin Exp Orthop, 4(1):54. doi:10.4172/2471-8416.100054.
Jackson J, Davies P, Leggett N, Nugawela MD, Scott LJ, Leach V, Richards A, Blacker A, Abrams P, Sharma J, Donovan J, Whiting P. Systematic review of interventions for the prevention and treatment of postoperative urinary retention. BJS Open. 2018 Nov 19;3(1):11-23. doi: 10.1002/bjs5.50114. eCollection 2019 Feb.
Cakmak M, Yildiz M, Akarken I, Karaman Y, Cakmak O. (2020). Risk Factors for Postoperative Urinary Retention in Surgical Population: A Prospective Cohort Study. J Urol Surg, 7(2): 144-148. doi: 10.4274/jus.galenos.2020.3544.
Pomajzl AJ, Siref LE. (2022). Post-op Urinary Retention. https://www.ncbi.nlm.nih.gov/books/NBK549844/. 25 Kasım 2022.
Agrawal K, Majhi S, Garg R. (2019). Post-operative urinary retention: Review of the literature. World J Anesthesiol, 8(1): 1-12. https://dx.doi.org/10.5313/wja.v8.i1.1.
Irish Surgical Research Collaborative; Croghan SM, Fleming CA, Mohan HM, Harji D, Bolger JC, Elliott JA, Boland M, Lonergan PE, Dillon P, Quinlan DM, Winter DC. RETention of urine After INguinal hernia Elective Repair (RETAINER study I and II). Int J Surg Protoc. 2021 Apr 23;25(1):42-54. doi: 10.29337/ijsp.137.
Zheng C, Guo C. Intraoperative Urine Output Is Associated with Postoperative Outcome in Pediatric Population Undergone Major Abdominal Operations. Ther Clin Risk Manag. 2019 Dec 18;15:1453-1460. doi: 10.2147/TCRM.S228528. eCollection 2019.
Ceratti RDN, Beghetto MG. Incidence of urinary retention and relations between patient's complaint, physical examination, and bladder ultrasound. Rev Gaucha Enferm. 2021 Mar 12;42:e20200014. doi: 10.1590/1983-1447.2021.20200014. eCollection 2021. English, Portuguese.
World Health Organization (WHO), Improving the Quality of Health Services: Tools and Resources, 2018. Available from: https://apps.who.int/iris/bitstream/handle/10665/310944/9789241515085-eng.pdf. 14 Aralık 2022.
Akhtar A, Macfarlane RJ, Waseem M. Pre-operative assessment and post-operative care in elective shoulder surgery. Open Orthop J. 2013 Sep 6;7:316-22. doi: 10.2174/1874325001307010316. eCollection 2013.
Official Gazette, Nursing Regulation, 2011. Number: 27910. https://www.resmigazete.gov.tr/eskiler/2011/04/20110419-5.html . December 14, 2022
Malley A, Kenner C, Kim T, Blakeney B. The role of the nurse and the preoperative assessment in patient transitions. AORN J. 2015 Aug;102(2):181.e1-9. doi: 10.1016/j.aorn.2015.06.004.
McGarry JR, Pope C, Green SM. Perioperative nursing: maintaining momentum and staying safe. J Res Nurs. 2018 Dec;23(8):727-739. doi: 10.1177/1744987118808835. Epub 2018 Dec 7.
Urpo M, Eskola S, Suominen T, Roos M. (2021). Teamwork: a perspective of perioperative nurses. Central European Journal of Nursing and Midwifery, 12;430-440. doi:10.15452/cejnm.2021.12.0018.
Yaban Simsek Z, Karaoz S. (2017). Effect of Nursing Interventions on Prevention and Management of Postoperative Urinary Retention for Patients with Orthopedic Surgery under Spinal Anaesthesia. International Journal of Caring Sciences, 10(1): 522-31.
Wu AK, Auerbach AD, Aaronson DS. National incidence and outcomes of postoperative urinary retention in the Surgical Care Improvement Project. Am J Surg. 2012 Aug;204(2):167-71. doi: 10.1016/j.amjsurg.2011.11.012. Epub 2012 May 3.
Meska MH, Mazzo A, Jorge BM, Souza-Junior VD, Negri EC, Chayamiti EM. Urinary retention: implications of low-fidelity simulation training on the self-confidence of nurses. Rev Esc Enferm USP. 2016 Sep-Oct;50(5):831-837. doi: 10.1590/S0080-623420160000600017. English, Portuguese.
Uslu Y, Yavuz M. (2016). Urinary retention and management after surgery. New Journal of Urology, 11 (1): 48-53.
Afazel MR, Jalali E, Sadat Z, Mahmoodi H. Comparing the effects of hot pack and lukewarm-water-soaked gauze on postoperative urinary retention; a randomized controlled clinical trial. Nurs Midwifery Stud. 2014 Dec;3(4):e24606. doi: 10.17795/nmsjournal24606. Epub 2014 Dec 29.
Dal U, Korucu AE, Eroglu K, Karatas B, Yalcin A. Sacral region massage as an alternative to the urinary catheter used to prevent urinary retention after cesarean delivery. Balkan Med J. 2013 Mar;30(1):58-63. doi: 10.5152/balkanmedj.2012.083. Epub 2013 Mar 1.
Leach D, Spaulding J, Thomas J, Conn C, Kutash M. The effect of caffeine on postoperative urinary retention after joint replacement surgery. Orthop Nurs. 2013 Sep-Oct;32(5):282-5. doi: 10.1097/NOR.0b013e3182a30184.
Zong J, You M, Li C. Effect of Kegel Pelvic Floor Muscle Exercise Combined with Clean Intermittent Self-catheterization on urinary retention after radical hysterectomy for cervical cancer. Pak J Med Sci. 2022 Mar-Apr;38(3Part-I):462-468. doi: 10.12669/pjms.38.3.4495.
Chen S, Sun H, Xu H, Zhang Y, Wang H. Effects of Acupuncture on Hospitalized Patients with Urinary Retention. Evid Based Complement Alternat Med. 2020 Jan 19;2020:2520483. doi: 10.1155/2020/2520483. eCollection 2020.
Brouwer TA, van Roon EN, Rosier PFWM, Kalkman CJ, Veeger N. Postoperative urinary retention: risk factors, bladder filling rate and time to catheterization: an observational study as part of a randomized controlled trial. Perioper Med (Lond). 2021 Jan 4;10(1):2. doi: 10.1186/s13741-020-00167-z.
Eldh AC, Joelsson-Alm E, Wretenberg P, Halleberg-Nyman M. Onset PrevenTIon of urinary retention in Orthopaedic Nursing and rehabilitation, OPTION-a study protocol for a randomised trial by a multi-professional facilitator team and their first-line managers' implementation strategy. Implement Sci. 2021 Jun 26;16(1):65. doi: 10.1186/s13012-021-01135-x.
Pierson M, Cretella B, Roussel M, Byrne P, Parkosewich J. A Nurse-Led Voiding Algorithm for Managing Urinary Retention After General Thoracic Surgery. Crit Care Nurse. 2022 Feb 1;42(1):23-31. doi: 10.4037/ccn2022727.
Seyedalangi H, Sajadi S A, Farsi Z, Mohamad Nejad E. (2015). The effect of warm compresses on urinary retention in male patients after cardiac catheterization hospitalized in military hospitals. MCS, 2(3):143-149. http://mcs.ajaums.ac.ir/article-1-86-en.html.
Roudbari F. (2017). The effects of cold and hot compresses in the supra-pubic area on urinary retention in elderly patients after surgery. https://en.irct.ir/trial/19269. 13 Aralık 2022.
COHEN J. The statistical power of abnormal-social psychological research: a review. J Abnorm Soc Psychol. 1962 Sep;65:145-53. doi: 10.1037/h0045186. No abstract available.
Meng MV, Tanagho EA. (2013). Physical Examination of the Genitourinary Tract. In: Smith and Tanagho's General Urology. McAninch JW, Lue TF. eds. Chapter 4. McGraw Hill.https://accessmedicine.mhmedical.com/content.aspx?bookid=508§ionid=4108808. 16 December 2022.
Nurcan C, Karadag M. (2015). Superficial Heat and Cold Applications in the Treatment of Knee Osteoarthritis. In: Osteoarthritis-Progress in Basic Research and Treatment. IntechOpen. https://doi.org/10.5772/60534.
Gunay AE, Karaman I, Yazici A, Oner M, Ekici M, Kafadar I, et al. (2022). Distribution of Orthopedic Surgery Interventions: Evaluation of 6236 Cases. Erciyes Med J, 44(2): 173-7. doi:10.14744/etd.2021.05873.
Other Identifiers
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Ankara Bilkent Sehir Hastanesi
Identifier Type: -
Identifier Source: org_study_id
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