<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20191217045764N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-17</date_registration>
      <primary_sponsor>Esfarayen University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the Effect of Coughing Technique (CT) and Nose Taking Technique (NTT) on Pain Intensity During Urinary Catheterization</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the Effect of Coughing Technique (CT) and Nose Taking Technique (NTT) on Pain Intensity During Urinary Catheterization</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50501</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Permutation blocks were used for random allocation. Eligible patients were divided into three groups of first, second and control groups (Each group is 25 people).
Our 6-state blocks and how the different permutations should be, using random numbers on the back of Dr. Kazem Mohammad's book of statistics and with their eyes closed, first a number was determined and the different permutations of the 6-state blocks were recorded in sequence from left to right. So that if the number one came A, and the number 2 belonged to group B and the number 3 belonged to group C. And different modes of ABCABC, AABBCC, .... were identified for the Case and control groups.</study_design>
      <phase>3</phase>
      <hc_freetext>The pain of urethral catheterization.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first group, patients are taught to first do a deep cough, pause for 10 seconds, and then do a second cough. The nurse inserts a urinary catheter into the urethra during the second cough. Intervention 2: Intervention group: Patients in the second group are instructed to squeeze the tip of the nose and exhale compressively at the same time as the closed glottis, so that the nurse inserts the urinary catheter into the urethra to the end. Intervention 3: Control group: In the control group, urinary tract catheterization is performed routinely.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is "No more information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 70, Imam Reza Alley12 , Imam Reza Ave</address>
        <city>Esfarayen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7698-9668</zip>
        <telephone>+98 58 3722 8757</telephone>
        <email>Info@esfrums.ac.ir</email>
        <affiliation>Esfarayen University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 70, Imam Reza Alley12 , Imam Reza Ave</address>
        <city>Esfarayen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7698-9668</zip>
        <telephone>+98 58 3722 7857</telephone>
        <email>Info@esfrums.ac.ir</email>
        <affiliation>Esfarayen University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be a man
People 18-65 years old who need catheterization
No problem in feeling and understanding pain like nephropathies
The patient has the ability to cooperate in assessing pain (no mental disorders)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Catheterization should not be performed within the range of effects of narcotic and non-narcotic analgesics.
Hematuria
The patient has a history of heart disease
People with active urinary tract infections
Score above 39 mm Hg based on the VAS scale
Pre-existing urinary catheter
Urinary tract stenosis
Pre-existing urinary tract pain (for example: Patients with chronic pelvic pain syndromes, interstitial cystitis)
Neurological patients with decreased level of consciousness
anesthetized and intubated Patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the first group, patients are taught to first do a deep cough, pause for 10 seconds, and then do a second cough. The nurse inserts a urinary catheter into the urethra during the second cough.</i_keyword>
      <i_keyword>Intervention group: Patients in the second group are instructed to squeeze the tip of the nose and exhale compressively at the same time as the closed glottis, so that the nurse inserts the urinary catheter into the urethra to the end.</i_keyword>
      <i_keyword>Control group: In the control group, urinary tract catheterization is performed routinely.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring the pain of urinary catheterization. Timepoint: Before, immediately and 15 minutes after urinary catheterization. Method of measurement: Visual analog scale, Numeric pain rating scale, Wong-Baker pain Rating scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood Pressure (BP). Timepoint: Before, immediately after, and 15 minutes after the intervention. Method of measurement: Use of BC1000 Barometer cuff.</sec_outcome>
      <sec_outcome>Pulse Rate (PR). Timepoint: Before, immediately after, and 15 minutes after the intervention. Method of measurement: Check the pulse rate with the using of radial artery.</sec_outcome>
      <sec_outcome>Respiration Rate (RR). Timepoint: Before, immediately after, and 15 minutes after the intervention. Method of measurement: Check the patient's number of respiratory rate per minute.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Esfarayen University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-19</approval_date>
        <contact_name>Ethics committee of Esfarayen University of Medical Sciences</contact_name>
        <contact_address>No. 70, Imam Reza Alley12 , Imam Reza Ave Esfarayen North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
