<?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>IRCT20110912007529N22</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-29</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>The effectiveness of tactile stimulation on unconscious patients</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of tactile stimulation on level of consciousness,  pain, and physiological parameters in unconscious patients admitted to the intensive care</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46297</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The block randomization which the patient was the randomization unit. Assignment of patients to groups is carried out by a statistical expert. Block selection is based on the random number table, Blinding description: Samplers and the statistical analyzer will be blind to
patients ‘random allocation of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>comatose patient.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group:The hand tactile stimulation group receive touch for 10 minutes, twice a day,11:00 am and 15:00 pm, for three days. Intervention 2: The second intervention group:The foot tactile stimulation group receive touch for 10 minutes, twice a day,11:00 am and 15:00 pm, for three days. Intervention 3: The control group don't receive any sensory stimulation.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All statistical data is available after being unidentifiable.

When:
The access period is up to one year after the publication of the results.

To whom:
Data is available to academic researchers.

Conditions:
Use of information for academic research projects is allowed.

Where to obtain:
Corresponding author; Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran, Iran.

How to obtain:
Requests for specific information should be sent by an email to the responsible author along with an explanation of why the data is needed.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Rejeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 2150 5121</telephone>
        <email>nrejeh@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Rejeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 2150 5121</telephone>
        <email>nrejeh@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 18 to 60 years old
The level of consciousness based on Glasgow coma scale is less than 12
The Richmond criteria in the range of 3- to 3+
Existence of pain in patients by CPOT criteria
Existence of normal brain CT
Hospitalization in ICU for the first time
The  lack of history of mental illness
The lack of addiction
The lack of sensory-motor dysfunction in the extremities
The lack of skin problems
The lack of diseases such as diabetes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Concurrent participation  in similar care plans such as massage
Use of receive neuromuscular blockers
Severe disorders levels of consciousness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B19.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coma, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group:The hand tactile stimulation group receive touch for 10 minutes, twice a day,11:00 am and 15:00 pm, for three days.</i_keyword>
      <i_keyword>The second intervention group:The foot tactile stimulation group receive touch for 10 minutes, twice a day,11:00 am and 15:00 pm, for three days.</i_keyword>
      <i_keyword>The control group don't receive any sensory stimulation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of consciousness. Timepoint: Before and after intervention, twice a day, during three days. Method of measurement: The GCS and FOUR scores.</prim_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Before and after intervention, twice a day, during three days. Method of measurement: Critical Care Pain Observation Tool (CPOT).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood Pressure. Timepoint: Before and after intervention, twice a day, during three days. Method of measurement: The monitor used in Intensive Care Unit.</sec_outcome>
      <sec_outcome>Respiratory Rate. Timepoint: Before and after intervention, twice a day, during three days. Method of measurement: The monitor used in Intensive Care Unit.</sec_outcome>
      <sec_outcome>Heart Rate. Timepoint: Before and after intervention, twice a day, during three days. Method of measurement: The monitor used in Intensive Care Unit.</sec_outcome>
      <sec_outcome>Oxygen Saturation. Timepoint: Before and after intervention, twice a day, during three days. Method of measurement: Pulse Oximeter.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-30</approval_date>
        <contact_name>Ethics committee of Shaded University</contact_name>
        <contact_address>Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
