xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05969145</url>
    </required_header>
    <id_info>
      <org_study_id>Ankara Bilkent Sehir Hastanesi</org_study_id>
      <nct_id>NCT05969145</nct_id>
    </id_info>
    <brief_title>The Effect of Hot-Cold Application to the Bladder After Orthopedic Surgery on Postoperative Urinary Retention</brief_title>
    <acronym>PUR</acronym>
    <official_title>The Effect of Hot-Cold Application to the Bladder After Orthopedic Surgery on Postoperative Urinary Retention</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara Yildirim Beyazıt University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara Yildirim Beyazıt University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The development of postoperative urinary retention (PUR) is a significant complication in&#xD;
        patients undergoing treatment due to orthopedic surgery. In particular, it is reported that&#xD;
        the incidence rate of PUR after spinal anesthesia is in the range of 6-60%. It is stated in&#xD;
        the literature that PUR can be prevented by reviewing factors such as bladder physical&#xD;
        examination, fluid intake status, anesthesia type, bladder discharge time/condition of&#xD;
        patients undergoing orthopedic surgery. For this purpose, our study showed that these&#xD;
        patients had globular physical examination screening and postoperative 2-6. it aims to&#xD;
        prevent postoperative urinary retention by applying hot and cold Decontamination to the&#xD;
        bladders of patients who cannot urinate spontaneously between hours.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Orthopedic surgery is a surgical treatment method based on the correction of the functions of&#xD;
        bones, November muscles, tendons, and ligaments in the body. Arthroplasty (hip, knee,&#xD;
        shoulder), arthroscopy (meniscopathy, rotator cuff rupture), limb fractures, structural&#xD;
        (hallux vagus, hallux rigidities, carpal tunnel syndrome, trigger finger), and developmental&#xD;
        (hip dysplasia) dysfunctions are the interventions in which the orthopedic surgical procedure&#xD;
        is performed. In orthopedic surgeries, the need for surgical treatment increases every day as&#xD;
        a result of degeneration in the musculoskeletal system with a decrease in mobilization due to&#xD;
        advancing age, November illness, trauma, or technological developments. In the United States,&#xD;
        30% of major surgical interventions involve orthopedic surgeries performed on elderly&#xD;
        individuals); in Turkey, it is reported that 33.5% of orthopedic surgeries are performed due&#xD;
        to trauma, and about 48% are performed on the lower extremities. Orthopedic surgeries are&#xD;
        practices that risk serious complications, as with any treatment option. Complications such&#xD;
        as nausea, vomiting, headache, hypotension, and postoperative urinary retention (PUR),&#xD;
        especially due to spinal anesthesia, may be observed in patients receiving treatment due to&#xD;
        orthopedic surgery. While the prevalence of PUR in orthopedic surgeries is 6-40% in the&#xD;
        literature, it is stated that this rate is higher (6-60%) after spinal anesthesia. Due to PUR&#xD;
        after orthopedic surgery, there is an increase in hospital stay times, susceptibility to&#xD;
        infection, deterioration in the quality of life, and associated cost increases.&#xD;
  &#xD;
        Postoperative urinary retention is a complication that manifests symptoms with problems such&#xD;
        as suprapubic pain, bladder spasm, and/or inability to urinate after surgical treatment. The&#xD;
        etiology of PUR includes factors caused by the patient (advanced age, male gender, anatomical&#xD;
        problems, comorbidity, neural transmission disorders), due to the surgical process (failure&#xD;
        to empty the bladder during the preoperative period, surgery lasts longer than 2 hours,&#xD;
        emergency surgery, opioid-NSAID-atropine use, amount of fluid taken) and due to anesthesia&#xD;
        (epidural/spinal anesthesia). 2-6 of the postoperative period. it gives symptoms as a result&#xD;
        of the absence of the first urine decrement between hours. As a result, serious problems such&#xD;
        as increased urinary pressure and acute kidney injury and/or dysfunction due to bladder&#xD;
        distension occur in patients. Management of PUR can be achieved by using physical examination&#xD;
        (globe monitoring), bladder catheterization, and ultrasonographic (USG) methods to diagnose&#xD;
        these problems at an early stage.&#xD;
  &#xD;
        Field health professionals, who have an important place in the conduct of health services,&#xD;
        offer the greatest contribution to the surgical treatment process with their understanding of&#xD;
        quality health care. In particular, nurses who are actively involved in the perioperative&#xD;
        process are the professional staff with the greatest responsibility for positively managing&#xD;
        health care. Nurses help to ensure the patient's comfort as soon as possible by providing&#xD;
        multidisciplinary cooperation in the management of complications that develop during this&#xD;
        process. For this purpose, nurses need to carry out the necessary practices and precautions&#xD;
        against the risk of developing PUR, which is one of the postoperative complications. In the&#xD;
        recently published Nursing Regulation, the nurses' authority to manage PUR is clearly stated&#xD;
        as &quot;interventions to be implemented by a nursing decision&quot; as &quot;A nurse can decide&#xD;
        independently or jointly with a physician to insert and remove a urinary catheter if she&#xD;
        cannot eliminate urinary retention with the interventions she can apply&quot;, &quot;Hot-cold&#xD;
        application&quot; intervention definition is clearly stated. Therefore, nurses evaluate the&#xD;
        patient by reviewing the existing risk factors of the patient and surgical process during the&#xD;
        perioperative period, providing emotional support for surgical stress, questioning&#xD;
        perioperative fluid intake, informing the patient about the consumption of&#xD;
        caffeine-containing drinks and plenty of water, monitor urine postoperatively, prefer&#xD;
        non-invasive methods (listening to water sound, relaxation, bladder massage, mobilization,&#xD;
        hot-cold application, ko mot/duck/sliders) primarily in case of PURE development, and&#xD;
        invasive methods as a last resort (urinary catheterization, ensuring the necessary&#xD;
        cooperation with the physician for interventional applications is one of the important&#xD;
        responsibilities in process management. In the literature, it is stated that hot-cold&#xD;
        application with bladder catheterization, one of the invasive methods, and hot-water&#xD;
        insertion of the hand, massage, mobilization, promotion of liquid and coffee consumption,&#xD;
        pelvic muscle exercise, and acupuncture are used in the management of PUR. In the studies&#xD;
        conducted, the first postoperative urine output time was reduced by sacral massage in the&#xD;
        management of PUR nurses; there was a rapid and permanent decrease in the development of PUR&#xD;
        accompanied by the urination algorithm from 21% to 3% observed. However, 59.5% of patients&#xD;
        with a hot compress applied to the bladder and 71.4% with cold application had urinary&#xD;
        retention regressed; a significant difference in the severity of urinary retention was&#xD;
        revealed by hot application; it is reported that urinary catheterization after the hot&#xD;
        application is applied to only 3.9% of the patients. Based on these results, it is seen that&#xD;
        the practices used by nurses to prevent and manage PUR have resulted in positive outcomes;&#xD;
        the hot and cold practice has also made significant contributions to PUR management. For this&#xD;
        purpose, it is envisaged that our study will contribute to the effective management of&#xD;
        hot-cold application of PUR to the bladder in orthopedic surgery patients, to the minimum&#xD;
        preference of invasive applications, to increasing the awareness of nurses about PUR&#xD;
        management, and to the literature.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_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.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Participant)</masking>
      <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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>physiological parameter, questionnaire</measure>
      <time_frame>the first 6 hours of the postoperative period</time_frame>
      <description>prevention of postoperative urinary retention by applying hot and cold to the bladder</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Postoperative Urinary Retention</condition>
    <arm_group>
      <arm_group_label>hot-cold application</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will be given a hot cold application to the bladder</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Routine clinical functioning will be applied to this group</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>application of thermophor</intervention_name>
      <description>The experimental group will be given hot and cold application to the bladder</description>
      <arm_group_label>hot-cold application</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥18 years of age,&#xD;
  &#xD;
            -  no urinary catheter inserted during the perioperative process, conscious and&#xD;
               orientated,&#xD;
  &#xD;
            -  no renal disease (chronic kidney failure, nephropathy, kidney transplantation,&#xD;
               prostate, urinary tract infection, history of stones in the urinary system)&#xD;
  &#xD;
            -  voluntary acceptance to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;18 years of age,&#xD;
  &#xD;
            -  intellectual disability or perception problem,&#xD;
  &#xD;
            -  communication disability,&#xD;
  &#xD;
            -  renal disease (chronic kidney failure, nephropathy, kidney transplantation, prostate,&#xD;
               urinary tract infection, history of stones in the urinary system)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gulay Yazici</last_name>
      <role>Study Director</role>
      <affiliation>Assoc. Dr.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elif Demirden Eristi</last_name>
      <phone>+90 505 691 66 45</phone>
      <email>demirdeneristi@gmail.com</email>
    </overall_contact>
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    </reference>
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      <citation>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.</citation>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>13880271</PMID>
    </reference>
    <reference>
      <citation>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&amp;sectionid=4108808. 16 December 2022.</citation>
    </reference>
    <reference>
      <citation>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.</citation>
    </reference>
    <results_reference>
      <citation>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.</citation>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ankara Yildirim Beyazıt University</investigator_affiliation>
      <investigator_full_name>Elif Demirden Erişti</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>orthopedic surgery</keyword>
    <keyword>hot-cold application</keyword>
    <keyword>postoperative urinary retention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Retention</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05969145
  org study id: Ankara Bilkent Sehir Hastanesi
  nct id: NCT05969145
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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.
  primary purpose: Health Services Research
  masking: Single (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.
  measure: physiological parameter, questionnaire
  time frame: the first 6 hours of the postoperative period
  description: prevention of postoperative urinary retention by applying hot and cold to the bladder
  arm group label: hot-cold application
  arm group type: Experimental
  description: This group will be given a hot cold application to the bladder
  arm group label: control group
  arm group type: No Intervention
  description: Routine clinical functioning will be applied to this group
  intervention type: Procedure
  intervention name: application of thermophor
  description: The experimental group will be given hot and cold application to the bladder
  arm group label: hot-cold application
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gulay Yazici
  role: Study Director
  affiliation: Assoc. Dr.
  last name: Elif Demirden Eristi
  phone: +90 505 691 66 45
  email: demirdeneristi@gmail.com
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  citation: 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.
  citation: 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.
  PMID: 13880271
  citation: 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&sectionid=4108808. 16 December 2022.
  citation: 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.
  citation: 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.
  responsible party type: Principal Investigator
  investigator affiliation: Ankara Yildirim Beyazıt University
  investigator full name: Elif Demirden Erişti
  investigator title: Principal investigator
  mesh term: Urinary Retention
  sharing ipd: No