<?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>IRCT20231120060120N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-10</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Implementing the Early Movement Protocol on the amount of Postoperative Bleeding</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effect of Implementing the Early Movement Protocol on the amount of Postoperative Bleeding in patients undergoing Open Heart Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75383</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: The researcher will be present at the bedside of the patients, will explain to them the purpose of the study, and the informed consent form will be completed by the patients to participate in the study, but the people in the intervention and control groups will not know which group they will be in. Both groups will receive routine ward care. That is, they will be taken out of bed on the third day after the operation. The people of the intervention group will be taken out of bed on the second day to move, but they will not know that they will be part of the intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Open Heart Surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: On the second day after open heart surgery, they will be taken out of bed to perform the movement protocol. Early movement will be done in such a way that first the patient will be placed in the bed in a semi-sitting position, he will be in this condition for 15 minutes, then he will return to the lying position. After one hour in bed, he will be in a sitting position, he will be in this position for 15 minutes, then he will return to the lying position. An hour later, he will be placed on the edge of the bed with his legs hanging for 15 minutes, then he will return to the lying position, after an hour he will sit on the side of the bed for 15 minutes and return to the bed again. An hour later, he will walk a few steps next to the bed and return to the bed again. All steps will be according to the patient's tolerance. Intervention 2: Control group: On the third day, according to the department's routine, they will be taken out of bed to implement the movement protocol.</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:
The data will be analyzed and the results will be presented in the article.

When:
Since 2024

To whom:
The data will be presented in the form of results in the article and researchers can access it

Conditions:
The data will be presented in the form of results in the article and researchers can access it

Where to obtain:
By sending an email to Mehla Dehmardeh, mahla.dahmardeh.nurse1999@gmail.com

How to obtain:
sending an email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahla Dahmardeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Hasabi Square, Zahedan University of Medical Sciences</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816113876</zip>
        <telephone>+98 54 3348 6610</telephone>
        <email>mahla.dahmardeh.nurse1999@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahla Dahmardeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Hasabi Square, Zahedan University of Medical Sciences</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816113876</zip>
        <telephone>+98 54 3348 6610</telephone>
        <email>mahla.dahmardeh.nurse1999@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range from 18 to 100 years
Getting a score of 19 and below from the bleeding prediction questionnaire after open heart surgery (people who will have moderate and severe risk)
Definitive diagnosis of the need for open heart surgery
Undergoing CABG heart surgery
The ability to move (not having a disability or restriction of specific movement after the operation)
Extubation from 18 hours after the operation
Elective and non-emergency open heart surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Getting a score of 20 or higher from the postoperative bleeding questionnaire in open heart surgery patients
Having an uncorrected coagulation disorder
Having a specific restriction of movement after the operation
Having uncontrollable heavy bleeding
Having severe changes in hemodynamic status
Unstable hemodynamic status after surgery
Mechanical ventilation for more than 48 hours</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T82.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mechanical complication of heart valve prosthesis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: On the second day after open heart surgery, they will be taken out of bed to perform the movement protocol. Early movement will be done in such a way that first the patient will be placed in the bed in a semi-sitting position, he will be in this condition for 15 minutes, then he will return to the lying position. After one hour in bed, he will be in a sitting position, he will be in this position for 15 minutes, then he will return to the lying position. An hour later, he will be placed on the edge of the bed with his legs hanging for 15 minutes, then he will return to the lying position, after an hour he will sit on the side of the bed for 15 minutes and return to the bed again. An hour later, he will walk a few steps next to the bed and return to the bed again. All steps will be according to the patient's tolerance.</i_keyword>
      <i_keyword>Control group: On the third day, according to the department's routine, they will be taken out of bed to implement the movement protocol</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bleeding volume measured in Bottle Chest. Timepoint: The first, Second and Third days after Open Heart Surgery. Method of measurement: Blood volume and drainage measured in Bottle Chest.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-24</approval_date>
        <contact_name>Ethics committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Dr. Hasabi Square, Zahedan University of Medical Sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
