<?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>IRCT20130616013690N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-17</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of foot reflexology on acute myocardial infarction patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology on fatigue, sleep quality, physiological indices and electrocardiogram changes in acute myocardial infarction patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53975</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Firstly, the patients are included in the study using convenience sampling. Then, a random block with four block is used to randomly assign patients into the both groups. Block list is provided by the "Create a block randomization list" software. Each block is then placed inside a envelope and numbered. In this way, after selecting a patient, a numbered envelope is opened, the patient is allocated into the intervention or control groups based on the contents of envelope, Blinding description: To conducting blinding, assistant researcher who collects data before and after the intervention, as well as statistician who analyzes the data, are blinded to the groups and the assignment of individuals in the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The patient lays on a bed in a quiet environment. The therapist places at the below of the patient's bed and each foot receives a reflexology for 15 minutes. reflexology will be done in three consecutive days at 4 pm. In order to do reflexology, firstly, the sweet almond oil is used. Then the reflexology would be done on following points the sleep points consisted of the thumb and Solar plexus, the inner and outer edges, soles and heel to the ankle of the foot which relate to the fatigue. Moreover, reflexology would be done on both the soles, between the shoulder line and diaphragm line in heart and chest reflex areas. Intervention 2: Control group: The control group does not receive any type of reflexology. This group receives routine care such as the intervention group.</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:
Primary outcomes would be shared.

When:
Starting 6 months after publication article

To whom:
People and researchers working in academic institutions

Conditions:
Data are provided for information only.

Where to obtain:
Data is available via email rambodma@yahoo.com.

How to obtain:
Data is available via email rambodma@yahoo.com.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoume Rambod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz. Zand Street, Namazi Square. School of Nursing Midwifery, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936–13119</zip>
        <telephone>+98 71 3677 4254</telephone>
        <email>rambodma@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoume Rambod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4258</telephone>
        <email>rambodma@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosed with acute myocardial infarction
Being 18 years old or above
Speak Persian language
being orient to time, person and place</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Infection or bleeding ulcer in the patient legs
Having previous history of cardiovascular diseases
Inability to tolerate foot reflexology
Having physical disability</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>ST elevati</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>121</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The patient lays on a bed in a quiet environment. The therapist places at the below of the patient's bed and each foot receives a reflexology for 15 minutes. reflexology will be done in three consecutive days at 4 pm. In order to do reflexology, firstly, the sweet almond oil is used. Then the reflexology would be done on following points the sleep points consisted of the thumb and Solar plexus, the inner and outer edges, soles and heel to the ankle of the foot which relate to the fatigue. Moreover, reflexology would be done on both the soles, between the shoulder line and diaphragm line in heart and chest reflex areas.</i_keyword>
      <i_keyword>Control group: The control group does not receive any type of reflexology. This group receives routine care such as the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue. Timepoint: 30 minutes before the intervention and four days after the intervention at 8:00 A.M. Method of measurement: Multidimensional Fatigue Inventory.</prim_outcome>
      <prim_outcome>Quality of sleep. Timepoint: 30 minutes before the intervention and four days after the intervention at 8:00 A.M. Method of measurement: Pittsburgh Sleep Quality Index.</prim_outcome>
      <prim_outcome>Physiological indices. Timepoint: 30 minutes before the intervention and every day from second to fourth days at 7 A.M. Method of measurement: Digital heart monitoring device.</prim_outcome>
      <prim_outcome>Tempreture. Timepoint: 30 minutes before the intervention and every day from second to fourth days at 7 A.M. Method of measurement: MASTECH Non Contact Infrared Medical Thermometer.</prim_outcome>
      <prim_outcome>Peripheral blood oxygen saturation level. Timepoint: 30 minutes before the intervention and every day from second to fourth days at 7 A.M. Method of measurement: Pulse Oximeter.</prim_outcome>
      <prim_outcome>Electrocardiogram changes. Timepoint: 30 minutes before the intervention and every day from second to fourth days at 7 A.M. Method of measurement: Digital heart monitoring device.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-28</approval_date>
        <contact_name>Ethic Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research affairs, seven floor, Shiraz University of Medical Science, beside Helal Ahmar, Zand Ave, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
