<?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>IRCT2013112515534N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-26</date_registration>
      <primary_sponsor>Vice chancellor for research, Shiraz University of Medical Sciences.</primary_sponsor>
      <public_title>Comparing the effects of music and the use of eyelid and earplugs on the quality of sleep in coronary patients.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects  of sensory restriction and music on sleep quality in patients with acute coronary syndrome in the cardiac care units 2012 .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14780</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Low sleep quality in patients with acute coronary syndrome..</hc_freetext>
      <i_freetext>Intervention 1: First intervention: The eyelids and earplugs will be given to the patients in the morning of the night of the study and the questions concerning them will be answered. In order not to interrupt the sleep of the patients, the devices are not removed during the night. The eyelids are soft and anti-allergic and are so chosen in order not to make patients feel uncomfortable. The earplugs are made of silicon and in addition to being comfortable are soundproof. Intervention 2: No special arrangements are taken into consideration in the control group. Intervention 3: Second intervention: The patient listens to the music composed based upon the frequency of sleep and is a mixture of the sounds heard in the nature. The music is played through light headphones which are removed carefully after the patient falls sleep.</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>Marzie Momennasab.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand street, Shiraz.</address>
        <city>Shiraz.</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71568-34939</zip>
        <telephone>+98 917 189 7581</telephone>
        <email>mnasab48@yahoo.com; momennasab@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzie Momennasab.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand street, Shiraz.</address>
        <city>Shiraz.</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71568-34939</zip>
        <telephone>+98 71 1647 4254</telephone>
        <email>mnasab48@yahoo.com; momennasab@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The patient: Suffers from acute coronary syndrome and is admitted in CCU; Has spent at least two nights in CCU; Is conscious and breathes spontaneously; Has no previous significant records of sleeping disorder; Does not suffer from auditory or visual disorders; Does not suffer from psychological or sensory-nervous disorders; Is not an addict; Has no records of advanced heart failure or pulmonary edema; Complains about his sleep in the ward.&#13;
Exclusion criteria: The patient: Is disinclined to continue cooperating; Has spent less than three nights in CCU; Death or an increase in the level of consciousness occurs; Has received narcotics up to four hours before intervention; Did PCI or angiography in the evening of the same day or these procedures are scheduled to be done in the following day; Needs pain killers due to feeling pain during the night; Needs various procedures during the night.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G 47.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of initiating and maintaining sleep[insomnias].</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention: The eyelids and earplugs will be given to the patients in the morning of the night of the study and the questions concerning them will be answered. In order not to interrupt the sleep of the patients, the devices are not removed during the night. The eyelids are soft and anti-allergic and are so chosen in order not to make patients feel uncomfortable. The earplugs are made of silicon and in addition to being comfortable are soundproof.</i_keyword>
      <i_keyword>No special arrangements are taken into consideration in the control group.</i_keyword>
      <i_keyword>Second intervention: The patient listens to the music composed based upon the frequency of sleep and is a mixture of the sounds heard in the nature. The music is played through light headphones which are removed carefully after the patient falls sleep.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The quality of sleep in coronary patients with acute coronary syndrome. Timepoint: At least at the second consecutive night spent in CCU and one night after that, in two consecutive nights. Method of measurement: SMHSQ questionnaire; Sleep assessment visual scale; Comfort visual scale.</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>none</sec_id>
        <issuing_authority>none</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, Shiraz University of Medical Sciences.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-03-06</approval_date>
        <contact_name>Shiraz University of Medical Sciences Ethics Committee.</contact_name>
        <contact_address>Zand street, Shiraz Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
