<?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>IRCT2012091010803N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-11-06</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effect of Nursing Measures on patients’ sleep quality who are hospitalized in the CCU  ward</public_title>
      <acronym></acronym>
      <scientific_title>To determine the effect of Nursing Measures on patients’ sleep quality who are hospitalized in the CCU Heart ward of Ekbatan Hospital in Hamadan city, 1391".</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>166</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11211</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>heart disease.</hc_freetext>
      <i_freetext>Intervention 1: Control Group receives the routine Nursing Care in CCU Ward. It means that no changes will be applied in the ward and no training will be given to staff as well. Intervention 2: After sampling the Control Group, Nursing measures are trained to nurses in 10 days, including  environment factor Control like  sound reduction by speaking softly, using silent Shoes, replacing damaged chairs, preparing medications in the treatment room, applying phones with flashes instead of rings, changing  worn trolleys , modulating lights and temperature. Furthermore, other measures are; providing Nursing and Medical measures at the right time, relieving pain, averting stress and using no diuretics close to sleep time.&#13;
Finally, after implementing Nursing Measures, in the morning of the third day of admission, the quality of Sleep of the participated/case Group will be measured via SMHSQ .</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>Dr Javad Faradmal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 1838 0090</telephone>
        <email>j80f@yahoo.com</email>
        <affiliation>Research Center for Health Sciences, Department of Epidemiology &amp; Biostatistics</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Khodayar Oshvandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Internal Medicine and Surgery, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 1838 0150</telephone>
        <email>oshvandi2004@yahoo.com</email>
        <affiliation>Department of Internal Medicine and Surgery,  Nursing and Midwifery School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Hospitalized in CCU; No sign of sleep disorder before admission; Having alertness &amp; Orientation &#13;
Exclusion Criteria: Discharging before day 3; Losing consciousness; Clinical Deterioration of the patient</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y84.0, Z50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cardiac catheterization, Cardiac rehabilitation,Cardiac arrest with successful resuscitation,Other cardiac arrhythmias,Paroxysmal tachycardia, Atrial fibrillation and flutter,Acute myocardial infarction, Subsequent myocardial infarction,Old myocardial inf</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control Group receives the routine Nursing Care in CCU Ward. It means that no changes will be applied in the ward and no training will be given to staff as well.</i_keyword>
      <i_keyword>After sampling the Control Group, Nursing measures are trained to nurses in 10 days, including  environment factor Control like  sound reduction by speaking softly, using silent Shoes, replacing damaged chairs, preparing medications in the treatment room, applying phones with flashes instead of rings, changing  worn trolleys , modulating lights and temperature. Furthermore, other measures are; providing Nursing and Medical measures at the right time, relieving pain, averting stress and using no diuretics close to sleep time.&#13;
Finally, after implementing Nursing Measures, in the morning of the third day of admission, the quality of Sleep of the participated/case Group will be measured via SMHSQ .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep qulity. Timepoint: before intervention, 2week after intervention. Method of measurement: SMHSQ questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nursing measures. Timepoint: before intervention, after intervention. Method of measurement: questionnaire made by scholar.</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 and Technology, Hamadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-08-13</approval_date>
        <contact_name>Ethics Committee of the Hamadan University of Medical Sciences</contact_name>
        <contact_address>Shahid fahmide avenue,  Hamadan University of Medical Sciences Hamadan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
