<?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>IRCT2015061112257N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-09-19</date_registration>
      <primary_sponsor>Vic chancellor for research, Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of  therapeutic touch on pain and physiological variables of patients undergoing of mechanical ventilation in intensive care units</public_title>
      <acronym></acronym>
      <scientific_title>The effect of  therapeutic touch on pain and physiological variables of patients undergoing of mechanical ventilation in intensive care units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12355</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patiants with airway artificial lung.</hc_freetext>
      <i_freetext>Intervention 1: This study is a randomized clinical trial with two groups of control and intervention groups were divided by the blocking method available    before of therapeutic thouch, pain and physiologic variables is recorded in intervention group.  &#13;
Therapeutic touch by touch therapist  is performance for patients, the time will be 20-30 minutes and after therapeutic touch, the pain and physiological variables were measured and recorded. Intervention 2: In the control group, the pain and physiologic variables will be recorded and then shame touch therapy is performanced  for 20 -30 minutes. Then the pain and physiological variables assessed and recorded.</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>Maryam Zaeimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Parvin Etesami St., Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515789589</zip>
        <telephone>+98 24 3377 2057</telephone>
        <email>zaeimi.maryam@yahoo.com; nursing@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Farhad Ramezani Badr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Parvin Etesami St., Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515789589</zip>
        <telephone>+98 24 3377 2513</telephone>
        <email>ramazanibadr@gmail.com; ramazani badr@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patiants who are under mechanical ventilation in intensive care units of consciousness by GCS&gt; 8; consent of the patient's relatives or legal guardians to participate in the study; patients aged at least 15 years and a maximum of 60 years old;  patients who were admitted in ICU for 24 hours; patients predicted to recieve intervention for 4 times;  patients who have pain on the results of the survey instrument and score more than 2 times introduced tools to gain. Exclusion criteria: patients with acute neurological disorders or trauma to the head; patients with a history of psychological problems; transferable to other word or fatal; patients suffering from neuromuscular, quadriplegia; patients taking the drug for patients with muscle relaxants; chronic diseases (diabetes, cancer, arthritis Rheumatoid); patients during therapeutic touch their blood pressure more or less than 20% of the base rate and rate of breathing more than 25 times per minute; heart rate more than 20% of the initial state and spo2 10% decline and a lack of coordination with ventilator; patients with acute pain and patiants have acute pain and short term as a result of some invasive treatment methods such as injection and venipuncture and change their positions.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J95-99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of the respiratory system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This study is a randomized clinical trial with two groups of control and intervention groups were divided by the blocking method available    before of therapeutic thouch, pain and physiologic variables is recorded in intervention group.  &#13;
Therapeutic touch by touch therapist  is performance for patients, the time will be 20-30 minutes and after therapeutic touch, the pain and physiological variables were measured and recorded.</i_keyword>
      <i_keyword>In the control group, the pain and physiologic variables will be recorded and then shame touch therapy is performanced  for 20 -30 minutes. Then the pain and physiological variables assessed and recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: after of every Session. Method of measurement: pain assessment of cpot scale.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: after of every Session. Method of measurement: mmhg , measured with a calibrated monitoring SAADAT company.</prim_outcome>
      <prim_outcome>Dyastolic blood pressure. Timepoint: after of every Session. Method of measurement: mmhg,measured with a calibrated monitoring SAADAT company.</prim_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: after of every Session. Method of measurement: mmhg,measured with a calibrated monitoring SAADAT company.</prim_outcome>
      <prim_outcome>Pulse rate. Timepoint: after of every Session. Method of measurement: the minutes of number,measured with a calibrated monitoring SAADAT company.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: after of every Session. Method of measurement: the minutes of number,measured with a calibrated monitoring SAADAT company.</prim_outcome>
      <prim_outcome>Spo2. Timepoint: after of every Session. Method of measurement: persentage minutesmeasured with a calibrated monitoring SAADAT company.</prim_outcome>
      <prim_outcome>Cardiac rhythm. Timepoint: after of every Session. Method of measurement: evaluation with 2 nurses.</prim_outcome>
      <prim_outcome>Raspiratory rhythm. Timepoint: after of every Session. Method of measurement: evaluation with 2 nurses.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient death. Timepoint: the patient death during the study. Method of measurement: questionnair.</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>Vic chancellor for research, Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-14</approval_date>
        <contact_name>Vic chancellor for research (science and technology), ethical Committee, Zanjan University of Medica</contact_name>
        <contact_address>Zanjan University of Medical Sciences, Azadi blvd. Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
