<?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>IRCT201501166318N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-03-14</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The reflexive effect of rubbing the palm of the foot palm (reflexology) on chest pain, anxiety, sleep quality, fatigue and physiological parameters in patients with acute myocardial infarction followed by treatment with Streptokinase.</public_title>
      <acronym></acronym>
      <scientific_title>The reflexive effect of rubbing the palm of the foot palm (reflexology) on chest pain, anxiety, sleep quality, fatigue and physiological parameters in patients with acute myocardial infarction followed by treatment with Streptokinase.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6771</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: The masseur keeps the curtains closed around the patient and minimizes the external noises. It is requested from the patient to lie down on the bed and his foot is washed with warm water, then a pillow is placed under his knee to relax the lower limbs. Talking to the patient is not allowed during the massage. Masseur must remove his ring, clock and jewelry and wash his hands. Then he sits on the chair at the end of the patient’s bed in a comfortable position and lubricates patient's left foot for one minute by using lubricanting cream (lubricant cream is the healthy brand of transparent and water soluble product, without salt, alcohol, and essence. it will do not create sensitivity and allergic reactions, and hasn't therapeutic value) and then for 20-minute foot reflexology massage in the heart of the left foot (ball center of foot) will be performed. Intervention 2: Intervention 2: The masseur keeps the curtains closed around the patient and minimizes the external noises. It is requested from the patient to lie down on the bed and his foot is washed with warm water, then a pillow is placed under his knee to relax the lower limb. Talking to the patient is not allowed during the massage. Masseur must remove his ring, clock and jewelry and wash his hands. Then he sits on the chair at the end of the patient’s bed in a comfortable position and lubricates patient's left foot for one minute by using lubricanting cream (lubricant cream is the healthy brand of transparent and water soluble product, without salt, alcohol, and essence. it will do not create sensitivity and allergic reactions, and hasn't therapeutic value) and then for 20-minute foot reflexology massage in the heart of the right foot, the heel (the abdomen and pelvis area) will be performed. Intervention 3: Intervention 3: No intervention, the  researcher will be present by the patient’s side in the whole duration of 20 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Monir Nobahar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty Nursing and Paramedical, Semnan University of Medical Sciences</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4170</telephone>
        <email>Nobahar43@semums.ac.irNobahar43@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Monir Nobahar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty Nursing and Paramedical, Semnan University of Medical Sciences</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4170</telephone>
        <email>Nobahar43@semums.ac.irNobahar43@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patient consent for participation in the study, acute myocardial infarction for the first time, treatment with Streptokinase, no history for the use of reflexology. Exclusion criteria: vision and hearing disorders, history of chronic pains, addiction to alcohol, or Opioids, leg fracture, sensory disorder, wound infecton in legs, skin diseases, graft, vascular disorders in legs, amputation in lower extremities, sensitivity to touch or massage, intolerance for intervention, any acute condition at the time of intervention, history of cardiopulmonary resuscitation; leg edema and keratosis.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute myocardial infarction, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: The masseur keeps the curtains closed around the patient and minimizes the external noises. It is requested from the patient to lie down on the bed and his foot is washed with warm water, then a pillow is placed under his knee to relax the lower limbs. Talking to the patient is not allowed during the massage. Masseur must remove his ring, clock and jewelry and wash his hands. Then he sits on the chair at the end of the patient’s bed in a comfortable position and lubricates patient's left foot for one minute by using lubricanting cream (lubricant cream is the healthy brand of transparent and water soluble product, without salt, alcohol, and essence. it will do not create sensitivity and allergic reactions, and hasn't therapeutic value) and then for 20-minute foot reflexology massage in the heart of the left foot (ball center of foot) will be performed.</i_keyword>
      <i_keyword>Intervention 2: The masseur keeps the curtains closed around the patient and minimizes the external noises. It is requested from the patient to lie down on the bed and his foot is washed with warm water, then a pillow is placed under his knee to relax the lower limb. Talking to the patient is not allowed during the massage. Masseur must remove his ring, clock and jewelry and wash his hands. Then he sits on the chair at the end of the patient’s bed in a comfortable position and lubricates patient's left foot for one minute by using lubricanting cream (lubricant cream is the healthy brand of transparent and water soluble product, without salt, alcohol, and essence. it will do not create sensitivity and allergic reactions, and hasn't therapeutic value) and then for 20-minute foot reflexology massage in the heart of the right foot, the heel (the abdomen and pelvis area) will be performed.</i_keyword>
      <i_keyword>Intervention 3: No intervention, the  researcher will be present by the patient’s side in the whole duration of 20 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chest pain intensity. Timepoint: Before and immediately after and  20 minutes after the intervention. Method of measurement: Chest pain intensity will be recorded before, immediately and 20 minutes after intervention. This intervention is being performed for three consecutive days and the intensities will be assessed. Information for each person will be recorded in form of questionnaire specfic for each patient. Visual analogue scale will be used for chest pain assessment.</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: Before and immediately after and  20 minutes after the intervention. Method of measurement: Fatigue will be measured and recorded before, immediately and 20 minutes after the intervention. This intervention is being performed for three consecutive days and the intensities will be assessed. Information for each person will be recorded in form of questionnaire specific for each patient. Visual analogue scale will be used for chest pain assessment.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and immediately after and  20 minutes after the intervention. Method of measurement: Anxiety will be measured and recorded before, immediately and 20 minutes after the intervention. This intervention is being performed for three consecutive days and the intensities will be assessed. Information for each person will be recorded in form of questionnaire specfic for each patient. Visual analogue scale will be used for chest pain assessment.</prim_outcome>
      <prim_outcome>Physiological parameters. Timepoint: Before and immediately after and  20 minutes after the intervention. Method of measurement: Physiological parameters will be measured and recorded before, immediately and 20 minutes after the intervention. This intervention is being performed for three consecutive days and the intensities will be assessed. Information for each person will be recorded in form of questionnaire specific for each patient. The record of physiological parameters include ;blood pressure, pulse, respiration, temperature, blood oxygen saturation and cardiac rhythm (to determine the number of PVC and PAC).</prim_outcome>
      <prim_outcome>Quality of sleep. Timepoint: before intervention and the day4th. Method of measurement: The Quality of sleep will be measured and recorded before the intervention and on the day 4th. The Pittsburgh questionnaire will be used for assessing the quality of sleep. Information for each person will be recorded in a specfic questionnaire for each patient.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-12</approval_date>
        <contact_name>Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan, University of Medical Sciences,Nursing and Paramedical Faculty Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
