<?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>IRCT2015052622418N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-06-26</date_registration>
      <primary_sponsor>Vice chancellor for research of, mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Prevention of delirium after open heart surgery</public_title>
      <acronym>-</acronym>
      <scientific_title>Evaluation of the effects of preventive nursing measures on delirium incidence for patients with open heart surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19338</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: -.</study_design>
      <phase>2</phase>
      <hc_freetext>Delirium.</hc_freetext>
      <i_freetext>Intervention 1: After sampling in the control group, preventive measures are done by researcher in the intervention group from the first day after surgery till the end of the fifth day such as: Installation of clock and calendar at the room, informing time, place and the last event to the patient three times a day, using proper lighting during the day and night, providing glasses, hearing aids and dentures to the patients who already used these devices,  Prevention from dehydration (drinking enough liquids in case of dehydration and no contraindications),  Encouraging the patient to move out of bed and helping him/her to do personal activities in order to maintain his independence,  Preparations for a proper sleep (not using coffee, tea and dairy products before sleep time,  enough exercise during the day, Reducing or eliminating unwanted extra noise around the bed and gentle massage on the back of the patient), preventing constipation (enough drinking, proper food diet with enough fiber and exercise during the day) not using physical limitations if possible, using local languages in the care of patients with diverse language and culture, using replaced oxygen to keep content of arterial oxygen above 95% and regular scheduled visit of the family and friends twice a day, each time for 30 minutes.  &#13;
The role of family and close friends at the patient bedside: (1) informing the patient about the place, time and recent events, providing the patient's favorite music or radio program or provide a cassette that recorded the voices of family members) 2( present the familiar objects in the room by their patients (photos, books, newspapers, pillows or soft pillows). Intervention 2: The researcher selects control group patients among all eligible patients who participate in this study. The control group received the usual nursing care and haloperidol injection.</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>Davod Adabifirozjayi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Centre, Health Network, Ayatollah Salehi Street, Ghaemshar, Mazandaran</address>
        <city>Ghaemshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00984736131167</zip>
        <telephone>+98 11 4235 0936</telephone>
        <email>Daf922@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Mohammadali Heydarigorji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Sari, Mazandaran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00984736131167</zip>
        <telephone>+98 11 3379 5579</telephone>
        <email>heydarigorji@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
 no record of delirium before open heart surgery; Age of over 18 years; an elective open heart surgery&#13;
Exclusion criteria:&#13;
Impairment of consciousness; stroke; using psychological drugs; having a depressive disorder; Recent use of opiate drug and alcohol; absolute blindness and deafness; aphasia due to the inability to fill the questionnaire; having delirium on the first day after surgery; emergency heart surgery; having intubation more than 24 hours after surgery; died during surgery or during investigation; and Patients refuse to cooperate with preventive nursing measure during the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delirium, not induced by alcohol and other psychoactive substances</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After sampling in the control group, preventive measures are done by researcher in the intervention group from the first day after surgery till the end of the fifth day such as: Installation of clock and calendar at the room, informing time, place and the last event to the patient three times a day, using proper lighting during the day and night, providing glasses, hearing aids and dentures to the patients who already used these devices,  Prevention from dehydration (drinking enough liquids in case of dehydration and no contraindications),  Encouraging the patient to move out of bed and helping him/her to do personal activities in order to maintain his independence,  Preparations for a proper sleep (not using coffee, tea and dairy products before sleep time,  enough exercise during the day, Reducing or eliminating unwanted extra noise around the bed and gentle massage on the back of the patient), preventing constipation (enough drinking, proper food diet with enough fiber and exercise during the day) not using physical limitations if possible, using local languages in the care of patients with diverse language and culture, using replaced oxygen to keep content of arterial oxygen above 95% and regular scheduled visit of the family and friends twice a day, each time for 30 minutes.  &#13;
The role of family and close friends at the patient bedside: (1) informing the patient about the place, time and recent events, providing the patient's favorite music or radio program or provide a cassette that recorded the voices of family members) 2( present the familiar objects in the room by their patients (photos, books, newspapers, pillows or soft pillows)</i_keyword>
      <i_keyword>The researcher selects control group patients among all eligible patients who participate in this study. The control group received the usual nursing care and haloperidol injection.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The incidence of delirium. Timepoint: Patients of open heart surgery should be evaluated for delirium incidence during the day before surgery between 16 to 20 p.m. then, they have to be evaluated one day after surgery until the end of the fifth day of hospitalization once a day, at the same time. This evaluation is due to an increase of the delirium incidences in this period. Method of measurement: The measure of the delirium incidence is based on Neecham questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>Vice chancellor for research of, mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-24</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Start of valiye asr highway, Imam Square, Sari, Mazandaran Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
