<?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>IRCT2016062128563N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-09</date_registration>
      <primary_sponsor>Vice chancellor for research of Qazvin university of medical science</primary_sponsor>
      <public_title>The effect of tactile stimulation on vital signs and consciousness of traumatic brain injury patients hospitalized in intensive care units</public_title>
      <acronym></acronym>
      <scientific_title>The effect of tactile stimulation on vital signs and consciousness of traumatic brain injury patients hospitalized in intensive care units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-11-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23153</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Using two-color balls in white (for control) and red (for intervention) for randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>head trauma Patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention in this case would be The intervention group, touch the wrist and  the whole hand For 5 minutes, In the morning and evening&#13;
for control group, all the routine cares will be delivered.  Intervention will proceed  in  the first to the fifth day of hospitalization.Thus the 5 minutes before the intervention, researcher will be measured  patient's vital signs, including blood pressure and pulse rate and respiration, body temperature and measure and record the patient's level of consciousness. Nurse fingers then gently placed around the patient's wrist without any Pressure.Time touching the patient's wrist and touch the whole hand is 5 minutes. Immediately after the intervention Again, vital signs and level of consciousness will be measured and recorded.This interference in the morning(11 am) and evening(17pm) for patients in this study was done. Intervention 2: Control group:the control group, vital signs twice a day (at 11 am and 5 evenings) with an interval of 5 minutes, while rejecting any intervention on the patient.</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>Dr. Leily Yekeh fallah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid  Bahonar Blvd, Qazvin University of Medical Sciences, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 283336001</telephone>
        <email>info@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Leily Yekeh fallah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Bahonar Blvd, Qazvin University of Medical Sciences, Qazvin ,</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>_</zip>
        <telephone>+98 283336001</telephone>
        <email>info@qums.ac.ir</email>
        <affiliation>Qazvin 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: The patient is hospitalized with a diagnosis of head trauma; Patient age ranged from 18 to 65 years; diagnosis of underlying disease such as diabetes (neuropathy due to possible based on patient records) is not; upper limb disorders in no sense; upper limb disorders in no sense; The patient's level of consciousness is in the range of 5 to 8; patient mental problems such as hallucinations or have anxiety disorders&#13;
&#13;
Exclusion criteria:patient dissatisfaction partners to continue to participate in the study; sample transport to other centers outside the city of Qazvin; a sharp drop in the level of consciousness suddenly; patients in both groups during the study and control at the same time patient care plans similar companies such as massage and relaxation techniques</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S00-S09</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injuries to the head</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention in this case would be The intervention group, touch the wrist and  the whole hand For 5 minutes, In the morning and evening&#13;
for control group, all the routine cares will be delivered.  Intervention will proceed  in  the first to the fifth day of hospitalization.Thus the 5 minutes before the intervention, researcher will be measured  patient's vital signs, including blood pressure and pulse rate and respiration, body temperature and measure and record the patient's level of consciousness. Nurse fingers then gently placed around the patient's wrist without any Pressure.Time touching the patient's wrist and touch the whole hand is 5 minutes. Immediately after the intervention Again, vital signs and level of consciousness will be measured and recorded.This interference in the morning(11 am) and evening(17pm) for patients in this study was done.</i_keyword>
      <i_keyword>Control group:the control group, vital signs twice a day (at 11 am and 5 evenings) with an interval of 5 minutes, while rejecting any intervention on the patient.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of consciousness. Timepoint: Before and after the intervention. Method of measurement: Using the Glasgow Coma Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vital sign. Timepoint: Before and after the intervention. Method of measurement: Using the monitoring -barometer-digital thermometer.</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 of Qazvin university of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-19</approval_date>
        <contact_name>Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin - shahid Bahonar Blvd. - Qazvin University of Medical Sciences Qazvin  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
