<?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>IRCT20210415050985N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-10</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of magnetic therapy on the incidence of post-operative acute urinary retention in patients undergoing surgery in hospital</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of magnetic therapy on the incidence of post-operative acute urinary retention in patients undergoing surgery in hospital: a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59142</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be simple and accessible and according to the inclusion criteria. The allocation of samples in the control and test groups will be done randomly and individually using the website www.sealedenvelope.com in random mode. The samples will also be homogenized by minimization software in terms of age, sex and type of surgery and its duration, Blinding description: The patient will not notice the magnet or non magnetic metal properties.</study_design>
      <phase>N/A</phase>
      <hc_freetext>urinary retention.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Magnets are glued at points P6, H7 on the right and left hands, and points SP6, ST36 only on the left foot, and one point on the left foot of the bladder / gastrointestinal tract. The total time the magnets are in place will be about 35 minutes. Intervention 2: Control group: Non-magnetic irons are glued at points P6, H7 on the right and left hands, and points SP6, ST36 on the left foot only, and a point on the sole of the left foot corresponding to the bladder / gastrointestinal tract. The total time the magnets are in place will be about 5.35 minutes.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after unidentified individuals

When:
2022

To whom:
It will be available only to researchers working in academic and scientific institutions

Conditions:
no problem

Where to obtain:
Mohammad Sadegh Aboutalebi

How to obtain:
As soon as possible

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Sadegh Aboutalebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HezarJarib</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174893541</zip>
        <telephone>+98 31 3792 7574</telephone>
        <email>aboutalebi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Sadegh Aboutalebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174893541</zip>
        <telephone>+98 31 3792 7574</telephone>
        <email>aboutalebi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient informed consent
Patients at least 18 years old
Classes I and II are ranked according to the American Society of Anesthesiology (ASA)
The duration of surgery was more than 2 hours
Availability of places for putting magnets on the patient's body
Elective surgeries
Non-urological surgeries</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of urinary catheter
Drug addiction
Existence of heart problems
History of previous urinary retention
Existence of cardiovascular problems
Existence of pacemaker
Intervention to eliminate urinary retention and catheterization
patient expressing a feeling of urination when entering to  recovery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R33</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Retention of urine</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Magnets are glued at points P6, H7 on the right and left hands, and points SP6, ST36 only on the left foot, and one point on the left foot of the bladder / gastrointestinal tract. The total time the magnets are in place will be about 35 minutes.</i_keyword>
      <i_keyword>Control group: Non-magnetic irons are glued at points P6, H7 on the right and left hands, and points SP6, ST36 on the left foot only, and a point on the sole of the left foot corresponding to the bladder / gastrointestinal tract. The total time the magnets are in place will be about 5.35 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Elimination of urinary retention completely. Timepoint: During the study and the probable time of urination from the start of magnetite therapy. Method of measurement: obsevation.</prim_outcome>
      <prim_outcome>The degree of relaxation. Timepoint: Before placing the magnets and the time to remove them and one hour after removing them. Method of measurement: Orally asked based on visual numerical scale 0 to 10.</prim_outcome>
      <prim_outcome>Nausea score. Timepoint: Before placing the magnets and the time to remove them and one hour after removing them. Method of measurement: Orally asked based on visual numerical scale 0 to 10.</prim_outcome>
      <prim_outcome>Heart rate beat. Timepoint: Before placing the magnets and the time to remove them and one hour after removing them. Method of measurement: Digital monitor.</prim_outcome>
      <prim_outcome>Average arterial blood pressure. Timepoint: Before placing the magnets and the time to remove them and one hour after removing them. Method of measurement: Barometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-08</approval_date>
        <contact_name>Faculty of Nursing, Management and Rehabilitation - Isfahan University of Medical Sciences</contact_name>
        <contact_address>HezarJarib Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
