<?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>IRCT20190719044268N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-23</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Foot Reflexology on the Incidence of Delirium, Sleep Disorder and Pain in Patients after Open Heart Surgery</public_title>
      <acronym></acronym>
      <scientific_title>The ٍEffects of Foot Reflexology on the Incidence of Delirium, Sleep Disorder and Pain in Patients after Open Heart Surgery in Baghiatollah and Jamaran Hospital in 2017 and 2018</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41467</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients were assigned to Experimental and Control Groups using four blocks Method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Delirium. Condition 2: Sleep Disorder. Condition 3: Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group were enrolled after open heart surgery after entering ICU OH ward for primary vital signs and demographic characteristics. After the initial symptoms persisted and arterial blood gas tests resolved, the patient's endotracheal tube was removed according to the patient's ُsighns and physician's order. About 10 minutes after the endotracheal tube was removed, the first session of reflexology massage was performed for 20 minutes. The second intervention was performed in the morning after surgery. Intervention 2: Control group: The control group was enrolled after open heart surgery after entering ICU OH department for primary vital signs and demographic characteristics. In these patients, normal and routine care for patients was 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only part of the data, such as information about the main variables and dependent variables, can be shared.

When:
Start accessing 8 months after printing results

To whom:
It will only be available to researchers working in academic and scientific institutions

Conditions:
In case of research in similar fields and with the discretion of the respected professor

Where to obtain:
Email a.fazlolah@gmail.com

How to obtain:
Upon email access to one week of documentation or files will be available

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Tayeb Moradian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiatollah University, Sheykh Bahaei St, Mulla Sadra St, Vanak Sq, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 8755 5500</telephone>
        <email>t.moradyan@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Tayeb Moradian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiatollah University, Sheikh Bahaei St, Mullasadra St, Vanak Sq, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 8755 5500</telephone>
        <email>t.moradyan@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Open heart Surgery for First Time
Non Emergency Open Heart Surgery
Healthy Foot</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Opium Addiction
Severe Hearing Impairment.
Existential Psychological Problems.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F05</hc_code>
      <hc_code>F51</hc_code>
      <hc_code>F45.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delirium due to known physiological condition</hc_keyword>
      <hc_keyword>Sleep disorders not due to a substance or known physiological condition</hc_keyword>
      <hc_keyword>Pain disorders related to psychological factors</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in the intervention group were enrolled after open heart surgery after entering ICU OH ward for primary vital signs and demographic characteristics. After the initial symptoms persisted and arterial blood gas tests resolved, the patient's endotracheal tube was removed according to the patient's ُsighns and physician's order. About 10 minutes after the endotracheal tube was removed, the first session of reflexology massage was performed for 20 minutes. The second intervention was performed in the morning after surgery.</i_keyword>
      <i_keyword>Control group: The control group was enrolled after open heart surgery after entering ICU OH department for primary vital signs and demographic characteristics. In these patients, normal and routine care for patients was performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Delirium. Timepoint: At 14, 19 and 6 in the morning after the first intervention session and at 14, 19 and 6 in the morning after the second intervention. Method of measurement: ( Delirium Observation Scale (DOS.</prim_outcome>
      <prim_outcome>Sleep Disorder. Timepoint: At 14:00 in the Mid day after the first intervention session and at 14:00 in the Mid day after the second intervention session. Method of measurement: Richards Campbell Sleep Questionnaire.</prim_outcome>
      <prim_outcome>Pain. Timepoint: In the Intervention group before the intervention and immediately after the intervention and the third time, two hours after the intervention, which will be completed 6 times in two days according to the two intervention sessions and in the control group, two times in the First day and Secound day After Extubation . Method of measurement: Visual Analoge Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood Pressure. Timepoint: After surgery, immediately after entering to ICU OH, before each intervention session and after intervention and two hours after intervention and in the control group, in addition to entering the ward, once ,first day after The operation was evaluated and second time was in the second morning after surgery. Method of measurement: Patients Blood Pressure Monitoring.</sec_outcome>
      <sec_outcome>Heart Rate. Timepoint: After surgery, immediately after entering to ICU OH, before each intervention session and after intervention and two hours after intervention and in the control group, in addition to entering the ward, once ,first day after The operation was evaluated and second time was in the second morning after surgery. Method of measurement: Patient Monitoring Device.</sec_outcome>
      <sec_outcome>Respiratory Rate. Timepoint: Immediately after the patient's admission to the ICU OH department. Method of measurement: Patient Monitoring Device.</sec_outcome>
      <sec_outcome>Saturation of Oxygen in Blood. Timepoint: Immediately after the patient's admission to the ICU OH department. Method of measurement: Patient Monitoring Device.</sec_outcome>
      <sec_outcome>Patients temperature. Timepoint: Immediately after the patient's admission to the ICU OH department. Method of measurement: 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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-04</approval_date>
        <contact_name>Baqiyatollah University of Medical Science</contact_name>
        <contact_address>Baqiyatollah University of Medical Sciences, Sheikh Bahaei St, Molla Sadra St, Vanak Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
