<?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>IRCT2013110215241N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-11-12</date_registration>
      <primary_sponsor>Isfahan University of Medical Science</primary_sponsor>
      <public_title>The effect of family communication and touch on unconscious patient</public_title>
      <acronym></acronym>
      <scientific_title>The effect of sensory stimulation on physiologic parameters of selected hospitals of Isfahan University of Medical Sciences' critical care patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14548</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>decreased level of consciousness.</hc_freetext>
      <i_freetext>Intervention 1: This intervention is performed in three 5 minute section with two 1 minute  intervals and  is performed twice on day between 10-12 hours in the morning and between 3-5 hours in the afternoon.  The families in the intervention group after wearing gown and  Slippers and washing hands and rubbing them with antibacterial jel  enter the ward and  sit on the chair near the bed, call the patient by one’s normal intonation, introduce oneself, hold the patient’s hands, touch the patient gently, talk to the patient about all the measures that had been done for the patient’s&#13;
improvement, and wait for 1 min. Then, in the second 5 min of the visit, the visitor again should touch the patient’s hands and face, make the patient familiar with&#13;
the time and place, and wait again for 1 min. In the third set of 5 min, the visitor should touch the patient again,&#13;
say goodbye, and ﬁnally state the time of the next visit. Intervention 2: In control group did not perform any intervention exception of  routin nursing care.</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>Mozhegan Naderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib street,Isfahan University of Medical Science</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 75 2422 0090</telephone>
        <email>www.mojgannaderi@nm.mui.ac.ir</email>
        <affiliation>Faculty of nursing &amp; Midwifery Isfahan University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Hojatollah Yousefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib street, Isfahan University of Medical Science</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1792 2944</telephone>
        <email>www.yousefi@nm.mui.ac.ir</email>
        <affiliation>Faculty of Nursing &amp; Midwifery Isfahan University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria :  Eighteen to sixty years of age in patients ; admitted to&#13;
ICU &gt;24 h ; 12≥GCS≥9 ; Presence of   hemodynamic stability: HR = 60-100 , MBP&gt;65mmHg, o2 sat &gt;90%; Being availabe patient family؛ Pass at least 6 hours from the time of opioid or sedative drugs injection; The patient might be intubated or not.  Exclution criteria: Addiction with cigarette, opioide or alchol; Presence of hearing impairment ; Presence of  skin disorders; Presence of psychatric disorder; Presence of life-threatening disease as advanced cancer and renal failer; Dopamin, TNG or Dobutamin  infusion during intervention; Create the conditions that needs to emergency Medical or Nursing intervention.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R40.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coma, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This intervention is performed in three 5 minute section with two 1 minute  intervals and  is performed twice on day between 10-12 hours in the morning and between 3-5 hours in the afternoon.  The families in the intervention group after wearing gown and  Slippers and washing hands and rubbing them with antibacterial jel  enter the ward and  sit on the chair near the bed, call the patient by one’s normal intonation, introduce oneself, hold the patient’s hands, touch the patient gently, talk to the patient about all the measures that had been done for the patient’s&#13;
improvement, and wait for 1 min. Then, in the second 5 min of the visit, the visitor again should touch the patient’s hands and face, make the patient familiar with&#13;
the time and place, and wait again for 1 min. In the third set of 5 min, the visitor should touch the patient again,&#13;
say goodbye, and ﬁnally state the time of the next visit.</i_keyword>
      <i_keyword>In control group did not perform any intervention exception of  routin nursing care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: 10 minute before intervention, immediately after intervention, 10 minute after intervention, 30 minute after intervention. Method of measurement: Connected to patient  hemodynamic manitoring.</prim_outcome>
      <prim_outcome>Diastilic blood pressure. Timepoint: 10 minute before intervention, immediately after intervention, 10 minute after intervention, 30 minute after intervention. Method of measurement: Connected to patient  hemodynamic manitoring.</prim_outcome>
      <prim_outcome>Pulse. Timepoint: 10 minute before intervention, immediately after intervention, 10 minute after intervention, 30 minute after intervention. Method of measurement: Connected to patient  hemodynamic manitoring.</prim_outcome>
      <prim_outcome>Oxygen sauration. Timepoint: 10 minute before intervention, immediately after intervention, 10 minute after intervention, 30 minute after intervention. Method of measurement: Connected to patient  hemodynamic manitoring.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Family anxiety. Timepoint: Before and after intervention. Method of measurement: Spielberger State-Trait Anxiety Inventory.</sec_outcome>
      <sec_outcome>Patient anxiety. Timepoint: Before and after intervention. Method of measurement: Fase anxiety scale.</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>Isfahan University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-11-27</approval_date>
        <contact_name>Isfahan University of Medical Science</contact_name>
        <contact_address>Hezarjarib street-Isfahan University of Medical Science Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
