<?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>IRCT2015051722300N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-09</date_registration>
      <primary_sponsor>Zahedan University of Medical Science</primary_sponsor>
      <public_title>Compare the effect of music therapy and foot reflexology on physiological parameters and pain in patients with non traumatic loss of consciousness in intensive care unit at Imam Ali Hospital, Zahedan 2015</public_title>
      <acronym></acronym>
      <scientific_title>Compare the effect of music therapy and foot reflexology on physiological parameters and pain in patients with non traumatic loss of consciousness in intensive care unit at Imam Ali Hospital, Zahedan 2015</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19253</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pain.</hc_freetext>
      <i_freetext>Intervention 1: Listening to music with headphones. Intervention time during three consecutive days for 30 minutes at 16 to 18. Intervention 2: Reflexology on the feet of the patient by the investigator. Intervention for 3 consecutive days for 30 minutes at 16-18. Intervention 3: Resting in bed for 30 minutes without any intervention.</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>Sarah Sheikh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Mashaheer Squar</address>
        <city>zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816913396</zip>
        <telephone>+98 54 3344 2482</telephone>
        <email>sarahsheikh@zums.ac.ir</email>
        <affiliation>Zahedan University of Medical Science, School of Nursing &amp; Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Yaghoubinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Mashaheer square</address>
        <city>zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816913396</zip>
        <telephone>+98 54 3344 2482</telephone>
        <email>yaghoubinia@gmail.com</email>
        <affiliation>Zahedan University of Medical Science, School of Nursing &amp; Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: the level of consciousness of the patient based on the GCS between 5 and 8 and able to respond to painful stimuli;  The patient's hemodynamic status is stable water and electrolytes; Lake of hearing defect ; Age over 18 years; The first is a history of hospitalization in ICU;  patient doesn’t have neuromuscular disorders and sensory-motor paralysis or does not receive the paralysis drug;  Patient has been healthy feet, especially in the feet and toe;  Lack of chronic pain in other parts of the body such as migraine and backache;  &#13;
Exclusion criteria: any fracture or trauma; Fixed invasive catheters except endotracheal tubes and IV;  The patient is awake and extubated during the study;  The type and dose analgesic is change by doctors;  Transfer to the operating room for surgery;  substantial drop in the level of consciousness;  The patient's guardian does not consent to continue participating in the study; Received anti-hypertensive and pressor drugs;</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52-R52.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, not elsewhere classified-Pain, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Listening to music with headphones. Intervention time during three consecutive days for 30 minutes at 16 to 18</i_keyword>
      <i_keyword>Reflexology on the feet of the patient by the investigator. Intervention for 3 consecutive days for 30 minutes at 16-18</i_keyword>
      <i_keyword>Resting in bed for 30 minutes without any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Behavioral pain scale. Timepoint: 5 minutes before and immediately after the intervention. Method of measurement: Measuring tools BPS (Behavioral pain scal).</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: 5 minutes before and immediately after the intervention. Method of measurement: observation of Monitoring.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: 5 minutes before and immediately after the intervention. Method of measurement: observation of Monitoring.</prim_outcome>
      <prim_outcome>Pulse. Timepoint: 5 minutes before and immediately after the intervention. Method of measurement: observation of Monitoring.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: 5 minutes before and immediately after the intervention. Method of measurement: observation of Monitoring.</prim_outcome>
      <prim_outcome>Arterial oxygen saturation(sao2). Timepoint: 5 minutes before and immediately after the intervention. Method of measurement: observation of Monitoring.</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>Zahedan University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-24</approval_date>
        <contact_name>Zahedan University of Medical Sciences</contact_name>
        <contact_address>Pardis Zahedan Univercity Of Medical Science, Doctor Hesabi Square Zahedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
