<?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>IRCT20171203037733N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-11</date_registration>
      <primary_sponsor>Khomein University of Medical Sciences</primary_sponsor>
      <public_title>The effect of body position on vital signs and comfort pattern of patients with coronary disease</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of three tripod, Semi-sitting and prone positions on vital signs and comfort pattern of patients with covid-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54252</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, patients are selected easily and entered into the study. They will then be randomly assigned (Simple randomized block assignment) to three groups A, B and C By statistical software.
Control group A in a semi-sitting position
Intervention group B in tripod position
Intervention group C in the prone position
Rand function in Excel software will also be used for randomization, Blinding description: This research is a clinical trial with three groups (two intervention groups and one control group) that the method of blinding in this study is double-blind that the main researcher and statistical analyzer have been blinded. In this way, the relevant checklists are coded according to codes B, A and C, and the sampler puts people in different positions according to randomly selected codes, and after collecting information by the sampler, this The information is entered by the data analyzer in SPSS statistical software and after extracting the obtained results, accurate analysis can be reported.</study_design>
      <phase>N/A</phase>
      <hc_freetext>coronavirus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: This group of patients is in group B, which is in the tripod position. Questionnaires related to demographic information, vital signs and patients' comfort level are completed before the intervention. Group B patients are placed in a tripod position and within 15 and 60 minutes, the patient's vital signs and comfort pattern are re-evaluated and recorded in the relevant questionnaire. Intervention 2: Intervention group2: This group of patients is in group C, which is in the prone position. Questionnaires related to demographic information, vital signs and patients' comfort level are completed before the intervention. Group C patients are placed in the prone position and within 15 and 60 minutes, the patient's vital signs and comfort pattern are re-evaluated and recorded in the relevant questionnaire. Intervention 3: Control group: Patients in group A are classified as patients in the control group who complete questionnaires related to demographic information, vital signs and patient comfort before the intervention. Group A patients are placed in a semi-sitting position with an angle of 30 degrees and within 15 and 60 minutes, the patient's vital signs and comfort pattern are re-evaluated and recorded in the relevant questionnaire.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I have not decided yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehran Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi St., Khomein School of Medical Sciences, Khomein, Iran</address>
        <city>Khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>38817-43364</zip>
        <telephone>+98 86 4622 1534</telephone>
        <email>mehranakbari1373@yahoo.com</email>
        <affiliation>Khomein university of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehran Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi St., Khomein School of Medical Sciences</address>
        <city>Khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>38817-43364</zip>
        <telephone>+98 86 4622 1534</telephone>
        <email>mehranakbari1373@yahoo.com</email>
        <affiliation>Khomein University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infection with Corona virus (positive PCR test)
Age 20 to 70 years
Willingness to participate in research
No connection to mechanical ventilation (no intubation)
Ability to communicate
No underlying respiratory disease
No pregnancy
No history of abdominal surgery during the last 6 months (for placement in the lumbar position)
Have at least 10% lung involvement with shortness of breath</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient death
Reluctance to participate in further research
Intubation of the patient during the research
Abdominal obesity
Abdominal surgery recently</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>RA01.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Covid-19</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 group1: This group of patients is in group B, which is in the tripod position. Questionnaires related to demographic information, vital signs and patients' comfort level are completed before the intervention. Group B patients are placed in a tripod position and within 15 and 60 minutes, the patient's vital signs and comfort pattern are re-evaluated and recorded in the relevant questionnaire.</i_keyword>
      <i_keyword>Intervention group2: This group of patients is in group C, which is in the prone position. Questionnaires related to demographic information, vital signs and patients' comfort level are completed before the intervention. Group C patients are placed in the prone position and within 15 and 60 minutes, the patient's vital signs and comfort pattern are re-evaluated and recorded in the relevant questionnaire.</i_keyword>
      <i_keyword>Control group: Patients in group A are classified as patients in the control group who complete questionnaires related to demographic information, vital signs and patient comfort before the intervention. Group A patients are placed in a semi-sitting position with an angle of 30 degrees and within 15 and 60 minutes, the patient's vital signs and comfort pattern are re-evaluated and recorded in the relevant questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vital signs. Timepoint: Before and after the intervention. Method of measurement: Heart rate, blood pressure and respiration rate.</prim_outcome>
      <prim_outcome>Comfort. Timepoint: Before and after the intervention. Method of measurement: Based on the Kolcaba questionnaire.</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>Khomein University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-01</approval_date>
        <contact_name>Ethics committee of Khomein University of Medical Sciences</contact_name>
        <contact_address>Azadi St., Khomein University of Medical Sciences Khomein Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
