<?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>IRCT201603094736N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-05</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of three methods of inhalation aromatherapy، massage and aromatherapy massage on cardiac patients' sleep quality</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of three methods of inhalation aromatherapy, massage and aromatherapy massage on sleep quality of cardiac patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5066</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Cardiac disease. Condition 2: Acute myocardial infarction. Condition 3: Heart failure. Condition 4: Acute pulmonary edema.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: In group I, before going to sleep at 10 P.M. two drops of lavender essential oil with the trade name of lavender essential oil and scientific name of Lavandula stoechas, manufactured by Barij Essence Company, will be dropped on a napkin and will be attached to the patient's cloth by the clamp in the chest area for 20 minutes and this process will be repeated for seven nights. This essence will be inhaled by the patient. This essential oil will be used in the pure form with 100 percent concentration. linalyl acetate and linalool are the major chemical compounds of this essence. Intervention 2: Intervention 2: In group 2, using sweet almond oil manufactured by Barij essence company, hands and feet ( from the planter surface of the foot up to the knee and the palm of the hand up to elbow ) are given massage by the trained nurse with the same sex for 20 minutes. The oil used in this kind of massage is sweet almond oil with the scientific name of Prunus amygdalus var dulcis and the trade name of sweet almond oil. This oil is manufactured by Kashan Barij Essence Company. The main component of this oil is glyceryl oleate. Intervention 3: Intervention 3: in group 3, using a combination of sweet almond oil and lavender ( 10-15 ml sweet almond oil mixed with lavender, dilution of 1/5 percent ) hands and feet ( from the planter surface of the foot up to the knee and the palm of the hand up to elbow ) are given massage by the trained nurse with the same sex for 20 minutes. The oil used in this kind of massage is sweet almond oil with the scientific name of Prunus amygdalus var dulcis and the trade name of sweet almond oil. This oil is manufactured by Kashan Barij Essence Company. The main component of this oil is glyceryl oleate. Intervention 4: Control group: The control group will receive usual care.</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>Alireza Khatony</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer street</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3827 9394</telephone>
        <email>akhatony@kums.ac.ir</email>
        <affiliation>Kermanshah School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Khatony</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah, Iran</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3827 9394</telephone>
        <email>akhatony@kums.ac.ir</email>
        <affiliation>Kermanshah School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Consent to participate in the study; not having skin disorders and eczema; Stable vital signs; Lack of allergies;  not having coagulation and bleeding disorders; not having mental disease and no history of hospitalization in psychiatric wards; not being sensitive to hand and foot massage and aromatherapy; score equal to or more than five from the Pittsburgh quality of sleep questionnaire and positive reaction to smell. Exclusion criteria: death or discharge; critically ill patient during the study; the patient's unwillingness to continue cooperation and oxygen administration for patients.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20-I25</hc_code>
      <hc_code>I21</hc_code>
      <hc_code>I50.9</hc_code>
      <hc_code>I50.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischaemic heart diseases</hc_keyword>
      <hc_keyword>Acute myocardial infarction</hc_keyword>
      <hc_keyword>Heart failure</hc_keyword>
      <hc_keyword>Acute pulmonary edema</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: In group I, before going to sleep at 10 P.M. two drops of lavender essential oil with the trade name of lavender essential oil and scientific name of Lavandula stoechas, manufactured by Barij Essence Company, will be dropped on a napkin and will be attached to the patient's cloth by the clamp in the chest area for 20 minutes and this process will be repeated for seven nights. This essence will be inhaled by the patient. This essential oil will be used in the pure form with 100 percent concentration. linalyl acetate and linalool are the major chemical compounds of this essence.</i_keyword>
      <i_keyword>Intervention 2: In group 2, using sweet almond oil manufactured by Barij essence company, hands and feet ( from the planter surface of the foot up to the knee and the palm of the hand up to elbow ) are given massage by the trained nurse with the same sex for 20 minutes. The oil used in this kind of massage is sweet almond oil with the scientific name of Prunus amygdalus var dulcis and the trade name of sweet almond oil. This oil is manufactured by Kashan Barij Essence Company. The main component of this oil is glyceryl oleate.</i_keyword>
      <i_keyword>Intervention 3: in group 3, using a combination of sweet almond oil and lavender ( 10-15 ml sweet almond oil mixed with lavender, dilution of 1/5 percent ) hands and feet ( from the planter surface of the foot up to the knee and the palm of the hand up to elbow ) are given massage by the trained nurse with the same sex for 20 minutes. The oil used in this kind of massage is sweet almond oil with the scientific name of Prunus amygdalus var dulcis and the trade name of sweet almond oil. This oil is manufactured by Kashan Barij Essence Company. The main component of this oil is glyceryl oleate.</i_keyword>
      <i_keyword>Control group: The control group will receive usual care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality. Timepoint: At the beginning of the study and eighth day. Method of measurement: Pittsburgh sleep quality 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>Vice Chancellor for Research, Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-23</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Kermanshah University of Medical Sciences, Shahid Beheshti Blvd Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
