<?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>IRCT20130424013110N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-17</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Shiatsu massage on agitated and vital signs of patients undergoing mechanical ventilation</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Shiatsu massage on restlessness and vital signs of patients undergoing mechanical ventilation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41890</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to allocate the patients randomly into two groups of treatment and control, at first 22 blocks of 4 with C and T letters (The letters indicate the intervention and control groups) are created in each 2 patients are belonged to the intervention group and 2 patients are belonged to the control group). Then the blocks are randomly selected and arranged to obtain a sequential combination of 68 letters. Each letter will be placed in a sealed packet according to the obtained sequence, Blinding description: It should be noted that the nurse who will measure the vital signs and the patient's restlessness level through the Richmond Instrument will be unaware of the type of intervention being performed, so it will be a single blind study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Agitation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the intervention group at one time alternate shiatsu on the Hugo points will be performed for 5 minutes massage and 2-minute rest to 20 minutes. Vital signs and severity of agitation before and after the intervention, using the Richmond score will determined. Intervention 2: Control group: Patients in the control group do not receive any Shiatsu massage intervention on the part of the researcher. In this group, only touch without pressure will be done for 20 minutes.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no additional information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Garshasbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Of Nursing And Midwifery, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3417 3503</telephone>
        <email>garshasbimasoume@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Harorani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Of Nursing, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3417 3503</telephone>
        <email>m.harorani@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 30 to 60 years
Level of consciousness higher than 7 on the Glasgow standard
Restlessness behavior according to Richmond criteria in the range of 2 + to 4 +</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Paralyzed hands
Spinal cord injury</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Symptoms and signs involving appearance and behavior</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the intervention group at one time alternate shiatsu on the Hugo points will be performed for 5 minutes massage and 2-minute rest to 20 minutes. Vital signs and severity of agitation before and after the intervention, using the Richmond score will determined.</i_keyword>
      <i_keyword>Control group: Patients in the control group do not receive any Shiatsu massage intervention on the part of the researcher. In this group, only touch without pressure will be done for 20 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Agitation. Timepoint: Before and after the intervention. Method of measurement: Richmond agitation scale.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before and after the intervention. Method of measurement: Digital pressure indicator gauge.</prim_outcome>
      <prim_outcome>Dyastolic blood pressure. Timepoint: Before and after the intervention. Method of measurement: Digital pressure indicator gauge.</prim_outcome>
      <prim_outcome>Pulse rate. Timepoint: Before and after the intervention. Method of measurement: Radial Pulse.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before and after the intervention. Method of measurement: Observation chest in a minute.</prim_outcome>
      <prim_outcome>Temperatures. Timepoint: Before and after the intervention. Method of measurement: Thermometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-29</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
