<?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>IRCT201204149469N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-06-30</date_registration>
      <primary_sponsor>Vice chancellor for research, Lorestan university of medical sciences</primary_sponsor>
      <public_title>Impact of sensory excitation performed by family members and nurses on the level of consciousness and vital signs in patients who are admitted to Intensive care unit and the general health of their families</public_title>
      <acronym></acronym>
      <scientific_title>Impact of sensory excitation performed by family members and nurses on the level of consciousness and vital signs in patients who are admitted to Intensive care unit and the general health of their families</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>73</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10046</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>head trauma.</hc_freetext>
      <i_freetext>Intervention 1: Second test group patient: Dying sensory excitation program will  be delivered by nurses. It will be applied two hours a day at 4-5 pm and 8-9 pm to the test groups for six days. Intervention 2: Control group patient: do not received Dying sensory excitation program, received Routine care. Intervention 3: First test group patient: Dying sensory excitation program will be delivered by family members. It will be applied two hours a day at 4-5 pm and 8-9 pm to the test groups for six days.</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>Mohammad Adinevand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of  Nursing, School of Nursing and Midwifery, Lorestan university of medical sciences.</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381351698</zip>
        <telephone>+66 16200140</telephone>
        <email>mohadineh@gmail.com</email>
        <affiliation>Lorestan university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahereh Toulabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department  of  Nursing, School of Nursing and Midwifery, Lorestan university of medical sciences.</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381351698</zip>
        <telephone>+98 66 1620 0140</telephone>
        <email>tolabi_t@lums.ac.ir; Toulabi_t@yahoo.com</email>
        <affiliation>Lorestan university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria (patients): head injury - GCS 5 to 10 - age16 to 65 years - obtained informed consent to participate in the study from family members,... &#13;
Exclusion criteria: discharge from the ICU before sixth day,...  Inclusion criteria (family members):  first-degree relatives - older than 18 years,...&#13;
 Inclusion criteria ( nurses): Trained Nurses</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S06.3, S06</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Focal brain injury, Epidural hemorrhage, Traumatic subdural hemorrhage, Traumatic subarachnoid hemorrhage, Intracranial injury with prolonged coma, Other intracranial injuries, Intracranial injury, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Second test group patient: Dying sensory excitation program will  be delivered by nurses. It will be applied two hours a day at 4-5 pm and 8-9 pm to the test groups for six days.</i_keyword>
      <i_keyword>Control group patient: do not received Dying sensory excitation program, received Routine care.</i_keyword>
      <i_keyword>First test group patient: Dying sensory excitation program will be delivered by family members. It will be applied two hours a day at 4-5 pm and 8-9 pm to the test groups for six days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient's consciousness level. Timepoint: 5 minutes before intervention and 30 minutes after intervention. Method of measurement: Glasgow coma score.</prim_outcome>
      <prim_outcome>Patient's vital signs. Timepoint: 5 minutes before intervention and 30 minutes after intervention. Method of measurement: Respiratory-cardiac monitoring system.</prim_outcome>
      <prim_outcome>Family members general health. Timepoint: immediately before and after the 1st, 6th and 12th hourly intervention session. Method of measurement: GHQ.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hospitalization period in ICU. Timepoint: Number of days hospitalized. Method of measurement: Checklist.</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>Vice chancellor for research, 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>Ethics Committee of Lorestan university of medical sciences</contact_name>
        <contact_address>Ethics Committee, Vice chancellor for research, Lorestan university of medical sciences. Khorramabad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
