<?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>IRCT201205139737N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-05-31</date_registration>
      <primary_sponsor>Lorestan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of Benson relaxation and slowe stroke back massage behind level of anxiety and vital signs unstable angina patients.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of Benson relaxation and slowe stroke back massage behind level of anxiety and vital signs unstable angina patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-05-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10281</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Unstable angina.</hc_freetext>
      <i_freetext>Intervention 1: Before intervention to 15 minutes on goals, the length of study, how Benson relaxation and massage, and their effects on anxiety and overall appearance of life, clarifications necessary separately to each unit of study is given and after obtaining consent, the questionnaire personal information is collected through interviews with patients and medical records. The level of anxiety by Spielberger anxiety questionnaire and through interviews with patients by trained research associate who is a nurse (other than the researcher or user intervention) is determined The vital signs          &#13;
(systolic and diastolic blood pressure, pulse, respiration) and examined by using electronic heart monitoring device SAADAT models by caliber engineer medical equipment, in three groups by the research partners, will review and ensure the reliability intera observer is involved in the massage group, massage therapy can be administered by a trained researcher.(ICC), confirmed it in writing to the Scientific Advisor to be announced Inter class     correlation (ICC), confirmed it in writing to the scientific Advisor to be announced. Massage using massage oil and warm hands in a day and time period&#13;
    10 minutes in the first 2 days of hospitalization, in the absence of patient privacy will be maintained within the coronary care unit. Intervention 2: Relaxation group,first individually and face to face how to do  Relaxation training then the researcher to practice your  Relaxation process the client performs and the client was asked that same day to do a  Relaxation time,which lasts 15-20 minutes intervention also about 20 minutes first 2 days of hospitalization ,is done. Benson Relaxation skills conducted a researcher in the samples using four criteria,each of which is 2 point will be assessed these criteria included being a quiet place ,close your eyes,breathe slow and motionless limbs were being if the samples 7 points  from 8 points to gain the necessary skills in applyng the huge intervention after learning   points and relaxation by the patient ,the level of anexety and the patients vital signs review and will be recorded. Intervention 3: Standard treatment is usually performed in the control group And you have not done any kind of intervention And only 15 minutes from their anxiety and changes in vital signs are measured.</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>Zeinab Ahmadipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorram Abad road km 5 - Boroujerd - opposite the village Kahrizak - Integrated Medical Sciences</address>
        <city>Khoram abad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 66 1620 0147</telephone>
        <email>www.ahmadipourz@yahoo.com</email>
        <affiliation>Lorestan University of Medical Ssciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorram Abad road km 5 - Boroujerd - opposite the village Kahrizak - Integrated Medical Sciences</address>
        <city>Khoram abad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1483877397</zip>
        <telephone>+98 66 1620 0147</telephone>
        <email>mohammad13565@yahoo.com</email>
        <affiliation>Lorestan University of Medical Ssciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age 75-18 years old; interest in massage and relaxation program participation; lack of physical illness that Masazhslamt endanger a person's spinal cord injury or surgery such as history; not having psoriasis (burn) bones (fractures) entered into the neck, back and sacrum; lack of drug and alcohol addiction; lack of corporate programs of relaxation; massage and similar techniques, lack of psychological problems (delirium, etc.); no history of hospitalization in CCU and no action Apart from anti-anxiety routine interventions (opioids and benzodiazepines) to create peace. Exclusion criteria: lack of patient cooperation and withdrew from the intervention; unstable conditions according to the patient's physician and any complications that arise during massage therapy or health-threatening.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unstable angina</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Before intervention to 15 minutes on goals, the length of study, how Benson relaxation and massage, and their effects on anxiety and overall appearance of life, clarifications necessary separately to each unit of study is given and after obtaining consent, the questionnaire personal information is collected through interviews with patients and medical records. The level of anxiety by Spielberger anxiety questionnaire and through interviews with patients by trained research associate who is a nurse (other than the researcher or user intervention) is determined The vital signs          &#13;
(systolic and diastolic blood pressure, pulse, respiration) and examined by using electronic heart monitoring device SAADAT models by caliber engineer medical equipment, in three groups by the research partners, will review and ensure the reliability intera observer is involved in the massage group, massage therapy can be administered by a trained researcher.(ICC), confirmed it in writing to the Scientific Advisor to be announced Inter class     correlation (ICC), confirmed it in writing to the scientific Advisor to be announced. Massage using massage oil and warm hands in a day and time period&#13;
    10 minutes in the first 2 days of hospitalization, in the absence of patient privacy will be maintained within the coronary care unit.</i_keyword>
      <i_keyword>Relaxation group,first individually and face to face how to do  Relaxation training then the researcher to practice your  Relaxation process the client performs and the client was asked that same day to do a  Relaxation time,which lasts 15-20 minutes intervention also about 20 minutes first 2 days of hospitalization ,is done. Benson Relaxation skills conducted a researcher in the samples using four criteria,each of which is 2 point will be assessed these criteria included being a quiet place ,close your eyes,breathe slow and motionless limbs were being if the samples 7 points  from 8 points to gain the necessary skills in applyng the huge intervention after learning   points and relaxation by the patient ,the level of anexety and the patients vital signs review and will be recorded.</i_keyword>
      <i_keyword>Standard treatment is usually performed in the control group And you have not done any kind of intervention And only 15 minutes from their anxiety and changes in vital signs are measured</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anexity. Timepoint: Before and immediately after intervention. Method of measurement: Spielberger questionnaire.</prim_outcome>
      <prim_outcome>Vital signs. Timepoint: Before and immediately after intervention. Method of measurement: 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>Lorestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-05-13</approval_date>
        <contact_name>Lorestan University of Medical Ssciences Ethics Committee</contact_name>
        <contact_address>Khorram Abad road km 5 - Boroujerd - opposite the village Kahrizak - Integrated Medical Sciences Poldokhtar  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
