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The Effect of Hot-Cold Application to the Bladder After Orthopedic Surgery on Postoperative Urinary Retention (PUR)

Primary Purpose

Postoperative Urinary Retention

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
application of thermophor
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Postoperative Urinary Retention focused on measuring orthopedic surgery, hot-cold application, postoperative urinary retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: ≥18 years of age, 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: <18 years of age, 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    hot-cold application

    control group

    Arm Description

    This group will be given a hot cold application to the bladder

    Routine clinical functioning will be applied to this group

    Outcomes

    Primary Outcome Measures

    physiological parameter, questionnaire
    prevention of postoperative urinary retention by applying hot and cold to the bladder

    Secondary Outcome Measures

    Full Information

    First Posted
    May 10, 2023
    Last Updated
    August 6, 2023
    Sponsor
    Ankara Yildirim Beyazıt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05969145
    Brief Title
    The Effect of Hot-Cold Application to the Bladder After Orthopedic Surgery on Postoperative Urinary Retention
    Acronym
    PUR
    Official Title
    The Effect of Hot-Cold Application to the Bladder After Orthopedic Surgery on Postoperative Urinary Retention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    November 15, 2023 (Anticipated)
    Study Completion Date
    January 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Yildirim Beyazıt University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The development of postoperative urinary retention (PUR) is a significant complication in patients undergoing treatment due to orthopedic surgery. In particular, it is reported that the incidence rate of PUR after spinal anesthesia is in the range of 6-60%. It is stated in the literature that PUR can be prevented by reviewing factors such as bladder physical examination, fluid intake status, anesthesia type, bladder discharge time/condition of patients undergoing orthopedic surgery. For this purpose, our study showed that these patients had globular physical examination screening and postoperative 2-6. it aims to prevent postoperative urinary retention by applying hot and cold Decontamination to the bladders of patients who cannot urinate spontaneously between hours.
    Detailed Description
    Orthopedic surgery is a surgical treatment method based on the correction of the functions of bones, November muscles, tendons, and ligaments in the body. Arthroplasty (hip, knee, shoulder), arthroscopy (meniscopathy, rotator cuff rupture), limb fractures, structural (hallux vagus, hallux rigidities, carpal tunnel syndrome, trigger finger), and developmental (hip dysplasia) dysfunctions are the interventions in which the orthopedic surgical procedure is performed. In orthopedic surgeries, the need for surgical treatment increases every day as a result of degeneration in the musculoskeletal system with a decrease in mobilization due to advancing age, November illness, trauma, or technological developments. In the United States, 30% of major surgical interventions involve orthopedic surgeries performed on elderly individuals); in Turkey, it is reported that 33.5% of orthopedic surgeries are performed due to trauma, and about 48% are performed on the lower extremities. Orthopedic surgeries are practices that risk serious complications, as with any treatment option. Complications such as nausea, vomiting, headache, hypotension, and postoperative urinary retention (PUR), especially due to spinal anesthesia, may be observed in patients receiving treatment due to orthopedic surgery. While the prevalence of PUR in orthopedic surgeries is 6-40% in the literature, it is stated that this rate is higher (6-60%) after spinal anesthesia. Due to PUR after orthopedic surgery, there is an increase in hospital stay times, susceptibility to infection, deterioration in the quality of life, and associated cost increases. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Urinary Retention
    Keywords
    orthopedic surgery, hot-cold application, postoperative urinary retention

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    a single-blind randomized controlled trial to determine the effect of hot-cold application to the bladder on postoperative urinary retention in orthopedic surgery patients.
    Masking
    Participant
    Masking Description
    The participant will not know that there is a control or experimental group. The result evaluator is an independent statistical expert, and the data analysis will be performed by a statistical specialist.
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    hot-cold application
    Arm Type
    Experimental
    Arm Description
    This group will be given a hot cold application to the bladder
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Routine clinical functioning will be applied to this group
    Intervention Type
    Procedure
    Intervention Name(s)
    application of thermophor
    Intervention Description
    The experimental group will be given hot and cold application to the bladder
    Primary Outcome Measure Information:
    Title
    physiological parameter, questionnaire
    Description
    prevention of postoperative urinary retention by applying hot and cold to the bladder
    Time Frame
    the first 6 hours of the postoperative period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ≥18 years of age, 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: <18 years of age, 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elif Demirden Eristi
    Phone
    +90 505 691 66 45
    Email
    demirdeneristi@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gulay Yazici
    Organizational Affiliation
    Assoc. Dr.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    The Effect of Hot-Cold Application to the Bladder After Orthopedic Surgery on Postoperative Urinary Retention

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