<?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>IRCT20150519022320N21</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-02</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of  sensory stimulation on the pain and restlessness of patients admitted to intensive care units</public_title>
      <acronym></acronym>
      <scientific_title>The effect of  dyang sensory stimulation on the pain and restlessness of patients admitted to intensive care units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38578</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 60 patients are selected for entry criteria. Subsequently, according to the random block method, people are divided into  two groups of 30 patients، intervention group and control group, Blinding description: In this study, patients and researcher colleague  do not aware of the type of group. Patients do not aware of their type of group because of decreased level of consciousness. The researcher colleague who measure pain and restlessness  in both groups do not aware whether the Patient  receive sensory stimulation (intervention group) or not (control group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: pain. Condition 2: restlessness.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention   gourp The sensory stimuli of Dyang are exactly based on the sensory arrangement in the Dyang's table, which includes visual, auditory, olfactory, tactile and motor stimulation. Stimulation of vision by turning off the flashlight in front of the patient's eyes for 2 seconds, stimulating the hearing by telling the patient's name and time, place and day near  the patient's ears three times, stimulating the smell of cotton be  soaked with rose water in the patient's nose for 5 seconds , Stimulation of the touch with hand pressure, massage and rubbing the cotton and gas in to the skin, first on one side of the body and then on the other side, and stimulating the movement by moving the joints of the hands, feet, hands, arms and shoulders by bending and straightening up and down. Alternate hands This intervention  continue  6 days for every  patient,two times a day and one hour for every time. Intervention 2: Control group: In the control group, do not any intervention. routine care is performed.</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 isnot  more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Ravari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rafsanjan University of Medical Sciences, Imam Ali Blvd, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717933777</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>ravary4776@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Ravari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Ali Bulvarde-central institute</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717933777</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>ravary4776@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18-60 years  old
There arenot numerous fracture in limbs and thorax
The level of conscious is between 5 -8</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Death
Starting a continuous infusion of sedative medicine for the patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89</hc_code>
      <hc_code>R45.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, not elsewhere classified</hc_keyword>
      <hc_keyword>Restlessness and agitation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention   gourp The sensory stimuli of Dyang are exactly based on the sensory arrangement in the Dyang's table, which includes visual, auditory, olfactory, tactile and motor stimulation. Stimulation of vision by turning off the flashlight in front of the patient's eyes for 2 seconds, stimulating the hearing by telling the patient's name and time, place and day near  the patient's ears three times, stimulating the smell of cotton be  soaked with rose water in the patient's nose for 5 seconds , Stimulation of the touch with hand pressure, massage and rubbing the cotton and gas in to the skin, first on one side of the body and then on the other side, and stimulating the movement by moving the joints of the hands, feet, hands, arms and shoulders by bending and straightening up and down. Alternate hands This intervention  continue  6 days for every  patient,two times a day and one hour for every time.</i_keyword>
      <i_keyword>Control group: In the control group, do not any intervention. routine care is performed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sensory stimulation of Dyang. Timepoint: For  maximum of thirty minutes. Method of measurement: Sensory stimulation table Dyang.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Sensory stimulation table Dyang. Method of measurement: Behavioral Pain scale.</sec_outcome>
      <sec_outcome>Restless. Timepoint: Before and fifteen minutes after diang of sensory stimulation. Method of measurement: Richmond Agitation-Sedation 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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-17</approval_date>
        <contact_name>Ethics committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Emam Ali Blv, Central Organization of the Central Organization of Medical Sciences Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
