<?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>IRCT201112048296N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-02-11</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effects of therapeutic massage done by nurses and patients companion on reducing anxiety, vital signs and the blood cortisol level in males hospitalized in coronary care unit .</public_title>
      <acronym>Massage therapy</acronym>
      <scientific_title>Comparing the effects of therapeutic massage done by nurses and patients companion on reducing anxiety, vital signs and the blood cortisol level in males hospitalized in coronary care unit .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Other</recruitment_status>
      <url>https://irct.ir/trial/8721</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Angina pectoris.</hc_freetext>
      <i_freetext>Intervention 1: The first group (massage by the nurse): The patient's vial signs will be assessed on 30 minutes before the massage will be done. Then the Spielberger questionnaire will be completed by the patient and a blood sample will be taken. Now, total body massage will be conducted by the nurse for about 60 min. Then, the patient's vital signs will be assessed and blood sample will be taken and Spielberger questionnaire will be completed again. Intervention 2: group II (massage by the patient's companion): &#13;
The patient's vial signs will be assessed on 30 minutes before the massage will be done. Then the Spielberger questionnaire will be completed by the patient and a blood sample will be taken. Now, total body massage will be conducted by the patient's companion for about 60 min. Then, the patient's vital signs will be assessed and blood sample will be taken and Spielberger questionnaire will be completed again. Intervention 3: Group III (control group):&#13;
This group does not receive massage therapy, but will receive the routine care.&#13;
The patient's vial signs will be assessed on 30 minutes after being in bed. Then the Spielberger questionnaire will be completed by the patient and a blood sample will be taken. assessing the patient's vital signs, blood sampling and Spielberger questionnaire will be repeated after 75 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>Rahman Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University of Medical Sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87155/111</zip>
        <telephone>+98 36 1444 8108</telephone>
        <email>rajabi_ra@kaums.ac.ir;  rajabi.rahman@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen Adib,</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan - 5 km ghotab Ravandi Blvd</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81755/111</zip>
        <telephone>+98 36 1555 2999</telephone>
        <email>adib1344@yahoo.com;</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A) Inclusion criteria: &#13;
1. Male patients hospitalized in CCU &#13;
2. Being  literate. &#13;
3. Being conscious&#13;
4. Stay in ward more than 3 days&#13;
5. Willing to participate &#13;
&#13;
B) Exclusion criteria: &#13;
1- Discharge from the ward&#13;
2- Loss of consciousness&#13;
3 -Having cardiac arrest during the past 72 hours&#13;
4- Receiving warfarin&#13;
5- Having known mental disorder&#13;
6- having cardiac pacemaker&#13;
7- Bradycardia (pulse rate less than 60) &#13;
8- Severe dyspnea&#13;
9- Having  burn more than 25% of BSA&#13;
10- Having known infectious disinvest or hepatitis and jaundice&#13;
11- Fever&#13;
12- Having amputed limb&#13;
13- Having known adrenal gland disorder&#13;
14- Having bone fractures in the past 2 months&#13;
15- Having known skin problem&#13;
16- Deep vein thrombosis&#13;
17- Having dialysis fistula.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>120</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Angina pectoris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first group (massage by the nurse): The patient's vial signs will be assessed on 30 minutes before the massage will be done. Then the Spielberger questionnaire will be completed by the patient and a blood sample will be taken. Now, total body massage will be conducted by the nurse for about 60 min. Then, the patient's vital signs will be assessed and blood sample will be taken and Spielberger questionnaire will be completed again.</i_keyword>
      <i_keyword>group II (massage by the patient's companion): &#13;
The patient's vial signs will be assessed on 30 minutes before the massage will be done. Then the Spielberger questionnaire will be completed by the patient and a blood sample will be taken. Now, total body massage will be conducted by the patient's companion for about 60 min. Then, the patient's vital signs will be assessed and blood sample will be taken and Spielberger questionnaire will be completed again.</i_keyword>
      <i_keyword>Group III (control group):&#13;
This group does not receive massage therapy, but will receive the routine care.&#13;
The patient's vial signs will be assessed on 30 minutes after being in bed. Then the Spielberger questionnaire will be completed by the patient and a blood sample will be taken. assessing the patient's vital signs, blood sampling and Spielberger questionnaire will be repeated after 75 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and after intervention. Method of measurement: Spielberger questionnaire.</prim_outcome>
      <prim_outcome>Serum cortisol. Timepoint: Before and after intervention. Method of measurement: Blood tests.</prim_outcome>
      <prim_outcome>Vital signs. Timepoint: Before and after the intervention. Method of measurement: Blood pressure (sphygmomanometre), temprature (medical termometer), pulse and respiration (by the researcher, in 1 min.).</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-31</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Kilometer 5, Ghotb ravandi bilvard Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
