<?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>IRCT20180519039711N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-04</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Local heat therapy on Comfort And Physiological parameters</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Local heat therapy on Comfort And Physiological parameters in the Patients with Acute Coronary Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44775</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting qualified samples, informed consent form is obtained. Eighty patients will be randomly assigned to either the intervention or control groups, initially 8 blocks of 10 different T and C letters (which represent the intervention and control groups). Belong to the control group). These blocks were then randomly selected to obtain an 80-fold combination of blocks, respectively. The resulting combination of letters is placed individually in 80 closed envelopes, with each patient opening one envelope in order to determine which group the patient falls into, Blinding description: Participants will be unaware of the type of intervention. Also, the nurse will not be informed about the type of intervention. Therefore, the study will be double blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: acute coronary syndrome. Condition 2: acute coronary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the experimental group, topical heat treatment with a temperature of 50 ° C will be performed in the posterior part of the chest.The hot pack is placed in the 4 to 11 chest area and the patient is placed in the supine position on the hot pack. The duration of the heat treatment is 23 minutes.Heat treatment is performed every 12 hours for 2 days. Intervention 2: Control group: In the placebo group patients will receive topical heat therapy in the posterior part of the chest at 37 ° C.The hot pack is placed in the 4 to 11 chest area and the patient is placed in the supine position on the hot pack. The duration of the course is 23 minutes.Heat treatment is performed every 12 hours for 2 days.</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:
Shared data including demographic and disease information, type and method of intervention, information about sleep quality of participants before and after intervention.

When:
Start the access period 6 months after the results are published.

To whom:
Researchers and people working in nursing education as well as nursing clinical staff.

Conditions:
The data can be used for education, research and clinical nursing. The applicant must be in the nursing field The data applicant only uses data for teaching, research and clinical nursing.

Where to obtain:
Mohamad golitaleb,Department of critical care nursing,school of nursing,Arak university of medical sciences
E mail:Mohamadgolitaleb@gmail.com
Tel:+989379366279

How to obtain:
After ensuring that the data applicant is in the nursing field, we will be immediately responded to the request form by email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahtab Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences. Basij square. Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3417 3503</telephone>
        <email>mahtabfarahanie@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad Golitaleb</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Campus Site, University of Medical Sciences, Basij Square, Arak, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>38481-7- 6941</zip>
        <telephone>+98 86 3417 3503</telephone>
        <email>mohamadgolitaleb@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The presence of a definitive diagnosis by a specialist physician of acute coronary syndrome
No musculoskeletal or thoracic or gastrointestinal diseases at the time of the disease.
Absence of swelling, scars, scratches and redness in the chest area
BMI between 18/5 and 25</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hypotension
Cardiac arrhythmia
Decrease of oxygen saturation of arterial blood</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>120-125</hc_code>
      <hc_code>121</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischaemic heart diseases</hc_keyword>
      <hc_keyword>Acute myocardial infarction-Subsequent myocardial infarction</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: In the experimental group, topical heat treatment with a temperature of 50 ° C will be performed in the posterior part of the chest.The hot pack is placed in the 4 to 11 chest area and the patient is placed in the supine position on the hot pack. The duration of the heat treatment is 23 minutes.Heat treatment is performed every 12 hours for 2 days.</i_keyword>
      <i_keyword>Control group: In the placebo group patients will receive topical heat therapy in the posterior part of the chest at 37 ° C.The hot pack is placed in the 4 to 11 chest area and the patient is placed in the supine position on the hot pack. The duration of the course is 23 minutes.Heat treatment is performed every 12 hours for 2 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comfort. Timepoint: Before and after intervention. Method of measurement: Kulkaba general comfort questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart beat. Timepoint: Before and after intervention. Method of measurement: Cardiac monitoring.</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Before and after intervention. Method of measurement: Cardiac monitoring.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before and after intervention. Method of measurement: Cardiac monitoring.</sec_outcome>
      <sec_outcome>Arterial Oxygen Saturation Percentage. Timepoint: Before and after intervention. Method of measurement: Pulse Oximeter.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-23</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Education and Research Deputy of Arak University of Medical Sciences, Basij Square, Arak, Iran Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
