<?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>IRCT20180728040617N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-28</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of Inhalation Aromatherapy with Citrus Aurantium and lavender on Sleep Quality, and Symptoms of Anxiety and Depression among Acute Coronary Syndrome Patients: A Parallel Randomized Controlled Trial</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Inhalation Aromatherapy with Citrus Aurantium and lavender on Sleep Quality, and Symptoms of Anxiety and Depression among Acute Coronary Syndrome Patients: A Parallel Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70834</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be divided into three aromatherapy groups with lavender, citrus aurantium and control by random block allocation using six blocks created by SPSS software. According to the sample size of 90 people in the present study, 15 blocks of six will be considered. Each patient will be randomly assigned to lavender aromatherapy group (A), citrus aurantium  aromatherapy (B) and control group (C) based on the order determined by the software. The sampling process will be done sequentially until the sampling is completed. People are assigned to the desired group in the order of their entry into the study and randomly through randomized blocks.</study_design>
      <phase>3</phase>
      <hc_freetext>acute coronary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In aromatherapy groups with lavender essential oil, every night for three consecutive nights, 5 drops of lavender essential oil will be poured on a piece of cotton and placed under the outer cover of the patient's pillow at a distance of about 20 cm from the nose. The cotton pad remains in place for 8 hours (10:00 PM to 6:00 AM). Intervention 2: Intervention group: In aromatherapy groups with citrus aurantium essential oil, 5 drops of citrus aurantium essential oil will be poured on a piece of cotton every night and for three consecutive nights and will be placed under the outer cover of the patient's pillow at a distance of about 20 cm from the nose. The cotton pad remains in place for 8 hours (10:00 PM to 6:00 AM). Intervention 3: Control group: Participants in the control group will receive distilled water as a placebo.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Some of the patient's demographic information can be shared after unidentifying individuals. All of the patient's sleep quality and symptoms of anxiety and depression assessment information can be shared with unidentified individuals.

When:
After publishing the article

To whom:
Project partners

Conditions:
People who do similar research.

Where to obtain:
Requests to receive documents are sent to the project's principal investigator (Seyedmohammad Mirhosseini) via email (smohammadmh@gmail.com). 
Address: Tehran St., Shahrood University of Medical Sciences, Shahroud, Iran. Contact number: 00982332395054, postal code: 3614773955

How to obtain:
After receiving the request, the data will be provided to the applicants by the project manager immediately via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedmohammad Mirhosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 3239 3811</telephone>
        <email>smohammadmh@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 3239 3811</telephone>
        <email>ebrahimi@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of acute coronary syndrome by a specialist
Full consciousness (GCS=15)
The patient has been admitted to the hospital 24-48 hours before the intervention.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acute psychological disorders
Neuroleptic medication
Opioid drug consumption 6 hours before the intervention
Allergy to plants and their scent
Lack of sense of smell</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute ischemic heart disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In aromatherapy groups with lavender essential oil, every night for three consecutive nights, 5 drops of lavender essential oil will be poured on a piece of cotton and placed under the outer cover of the patient's pillow at a distance of about 20 cm from the nose. The cotton pad remains in place for 8 hours (10:00 PM to 6:00 AM).</i_keyword>
      <i_keyword>Intervention group: In aromatherapy groups with citrus aurantium essential oil, 5 drops of citrus aurantium essential oil will be poured on a piece of cotton every night and for three consecutive nights and will be placed under the outer cover of the patient's pillow at a distance of about 20 cm from the nose. The cotton pad remains in place for 8 hours (10:00 PM to 6:00 AM).</i_keyword>
      <i_keyword>Control group: Participants in the control group will receive distilled water as a placebo.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety: Anxiety refers to the score that can be obtained from the Sigmund Anxiety and Depression Hospital Scale. Timepoint: before the intervention and 3 nights after the intervention (the morning of the fourth day). Method of measurement: Sigmunds' Hospital Anxiety and Depression Scale.</prim_outcome>
      <prim_outcome>Depression: Depression refers to the score that can be obtained from the Sigmund Anxiety and Depression Hospital Scale. Timepoint: Before the intervention and 3 nights after the intervention (the morning of the fourth day). Method of measurement: Sigmunds' Hospital Anxiety and Depression Scale.</prim_outcome>
      <prim_outcome>Sleep quality: Sleep quality refers to the score that can be obtained from the St. Mary's Hospital Sleep Quality Questionnaire. Timepoint: Before the intervention and 3 nights after the intervention (the morning of the fourth day). Method of measurement: St. Mary's Hospital 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-10</approval_date>
        <contact_name>Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran. Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
