<?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>IRCT201707248665N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-14</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Citrus Aurantium Aroma and Acupressure on sleep quality in patients undergoing percutaneous coronary intervention (PCI)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Citrus Aurantium Aroma and Acupressure on sleep quality in patients undergoing percutaneous coronary intervention (PCI)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9156</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart disease.</hc_freetext>
      <i_freetext>Intervention 1: In the first group (Citrus Aurantium Aroma) after getting informed consent, they will complete demographic and spielberger questionnaires at 10 o'clock. Cotton is stained with 2 drops of Citrus Aurantium put in front of the patient's nose and patients are asked to do 2-3 deep breathing. The cotton ball is then attached to patient's shirt using a pin and until 8am. Then the cotton bullet will be separated from the patient's clothing and will be discarded, and the sleep quality of the night will be checked by using SMHSQ. Intervention 2: In the second group (placebo aroma) after getting informed consent, they will complete demographic and Spielberger questionnaire at 10 o'clock. Cotton is stained with 2 drops of sunflower oil put in front of the patient's nose and patients are asked to do 2-3 deep breathing. The cotton ball is then attached to patient's shirt using a pin and until 8am. Then the cotton bullet will be separated from the patient's clothing and will be discarded, and the sleep quality of the night will be checked by using SMHSQ. Intervention 3: In the third group (Accupressure) after getting informed consent, they will complete demographic and spielberger questionnaires at 10 o'clock. The wristband, which has a metal button with a diameter of 0.7 cm, is closed for 1 night on both the right and left wrists of the patient so that the metal button is placed on the point of intervention (Shenmen). The pressure is applied to a patient who does not feel the pain and discomfort of the wrist strap. The sleep quality of the night will be checked by using SMHSQ. Intervention 4: In the fourth group (Placebo of accupressure) after getting informed consent, they will complete demographic and spielberger questionnaires at 10 o'clock. The wristband on both the right and left wrists of the patient will be closed so that the metal button is located 1-1/5 cm from the point of Shenmen (false point). The seaband is closed on the wrists for 1 night. The sleep quality of the night will be checked by using SMHSQ. Intervention 5: In the fifth group (Control) after getting informed consent in control group, they will complete demographic and spielberger questionnaires at 10 o'clock.&#13;
they will receive only routine nursing care. The sleep quality of the night will be checked by using 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>Hassan Babamohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 Kilometers of Damghan Road, Nursing Faculty, Semnan University of Medical Sciences, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4190</telephone>
        <email>babamohamadi@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Babamohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 Kilometers of Damghan Road, Nursing Faculty, Semnan University of Medical Sciences, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4190</telephone>
        <email>babamohamadi@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Age range 40-75 years; Diagnosis of acute myocardial infarction or angina pectoris requiring PCI; Non-use of herbal medicines in the past two weeks; Not having a history of sleep disorders in a recent month; No- narcotic drug use; no scars at the Shenmen point; Non-use sleep medication during the past month; no history of acupressure; lack of olfactory impairment; patients who are first placed under PCI.  Exclusion Criteria: Patient's unwillingness to cooperate or death; History of respiratory disorders or allergies to plants; Carpal tunnel syndrome; BMI&gt; 35.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20-I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischemic Heart Disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first group (Citrus Aurantium Aroma) after getting informed consent, they will complete demographic and spielberger questionnaires at 10 o'clock. Cotton is stained with 2 drops of Citrus Aurantium put in front of the patient's nose and patients are asked to do 2-3 deep breathing. The cotton ball is then attached to patient's shirt using a pin and until 8am. Then the cotton bullet will be separated from the patient's clothing and will be discarded, and the sleep quality of the night will be checked by using SMHSQ.</i_keyword>
      <i_keyword>In the second group (placebo aroma) after getting informed consent, they will complete demographic and Spielberger questionnaire at 10 o'clock. Cotton is stained with 2 drops of sunflower oil put in front of the patient's nose and patients are asked to do 2-3 deep breathing. The cotton ball is then attached to patient's shirt using a pin and until 8am. Then the cotton bullet will be separated from the patient's clothing and will be discarded, and the sleep quality of the night will be checked by using SMHSQ.</i_keyword>
      <i_keyword>In the third group (Accupressure) after getting informed consent, they will complete demographic and spielberger questionnaires at 10 o'clock. The wristband, which has a metal button with a diameter of 0.7 cm, is closed for 1 night on both the right and left wrists of the patient so that the metal button is placed on the point of intervention (Shenmen). The pressure is applied to a patient who does not feel the pain and discomfort of the wrist strap. The sleep quality of the night will be checked by using SMHSQ.</i_keyword>
      <i_keyword>In the fourth group (Placebo of accupressure) after getting informed consent, they will complete demographic and spielberger questionnaires at 10 o'clock. The wristband on both the right and left wrists of the patient will be closed so that the metal button is located 1-1/5 cm from the point of Shenmen (false point). The seaband is closed on the wrists for 1 night. The sleep quality of the night will be checked by using SMHSQ.</i_keyword>
      <i_keyword>In the fifth group (Control) after getting informed consent in control group, they will complete demographic and spielberger questionnaires at 10 o'clock.&#13;
they will receive only routine nursing care. The sleep quality of the night will be checked by using SMHSQ.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep Quality. Timepoint: At the end of study. Method of measurement: St Marry’s Hospital Sleep questionnaire.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-12</approval_date>
        <contact_name>Semnan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor of Research and Technology, Semnan University of Medical Sciences, Basidj Blv, Semnan, Iran Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
