<?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>IRCT20180205038626N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-12</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>study of the effects of Aromatherapy with Rose and Lavender on the Quality of Sleep in patients after CABG in Dr. Heshmat Hospital in Rasht, 2017-2018</public_title>
      <acronym></acronym>
      <scientific_title>study of the effects of Aromatherapy with Rose and Lavender on the Quality of Sleep in patients after CABG in Dr. Heshmat Hospital in Rasht, 2017-2018</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29540</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Since the nature of the interventions restricts the ability to run in a common room environment, it was decided that the rooms would randomly be randomized based on 6 random blocks and would be changed in three randomized rooms in order to eliminate potential confusion. In the eligible patients entered in each room, the intervention will be applied.</study_design>
      <phase>2</phase>
      <hc_freetext>Patients post cardiac artery bypass surgery.</hc_freetext>
      <i_freetext>Intervention group: The first group, a group of lavender essential oil, the second group is a group of medicinal herbs with a basil leaf essential oil..</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:
Patients in the two groups of patients undergoing lavender and flower mourning therapy are asked to inhale the lavender and flower of Mohammadi, which is as much as three drops, for 5 nights each night during the period from 21 to 23 Put on a piece of cloth attached to the patient pillow. It should be noted that during the intervention period, people who develop symptoms such as dyspnea or allergic symptoms will be excluded from the study. Monitor the patient in the department by the partner of the patient and the nurse. Then the sixth day of the questionnaire of sleep quality assessment is completed by the researcher. The researcher in the control group completes the sleep quality questionnaire without any intervention the morning of the day after entering the surgical department and the sixth day of the sleep quality questionnaire.

When:
Between 21:00 and 23:00

To whom:
For scholars working in academia and academia

Conditions:
After collecting data, SPSS-V.21 software is used to describe the data. Descriptive statistics (percentage) and mean (standard deviation) will be used. The normal distribution of quantitative amounts based on the Kolmogrov-Smironov test will be investigated. In order to compare the groups in terms of demographic characteristics, one-way analysis of variance (with Tukey's post hoc test) and Kruskal-Wallis test will be used if no normal distribution is made. In order to compare the groups in terms of qualitative demographic characteristics, the Chi-square test was used and for the qualitative variables of Kruskal-Wallis test (using the Man-Whitney post-mortem test along with the correction of Ben Freonny). To compare the mean sleep quality score in the three groups at the end of the intervention, the covariance analysis will be used by adjusting to the base sleep quality score and eliminating the effect of other adjuncts. In the absence of a condition for covariance analysis, stratified analysis will be used.

Where to obtain:
Dr. Heshmat Rasht Hospital - Valiasr Square, Baniyan St.

How to obtain:
Through automation correspondence or email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zahra ahmadnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Heshmat Rasht Hospital - Valiasr Square, Baniyan St.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193955588</zip>
        <telephone>+98 13 3361 8177</telephone>
        <email>zahmadnia@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zahra ahmadnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Heshmat Rasht Hospital - Valiasr Square, Baniyan St.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193955588</zip>
        <telephone>+98 13 3361 8177</telephone>
        <email>zahmadnia@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 65 years or less (according to the WHO, the age of 65 and older is considered to be aged, so to ensure that the sense of aging is caused by aging), the patient's willingness to participate in the study, the inability of patients to use anti-depressant drugs and narcotics , Speaking of patients' language in Persian, having clear verbal ability, having no history of known psychological disorders, having no history of allergic rhinitis and other respiratory and sinusitis problems, having no history of certain systemic or chronic diseases, affecting the sense of smell or hearing and having no history Sleep disorders and reliance on non-use of medications and sleep apnea.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I97.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other functional disturbances following cardiac surgery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first group, a group of lavender essential oil, the second group is a group of medicinal herbs with a basil leaf essential oil.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality. Timepoint: 6 days after aromatherapy with Rose and Lavender. Method of measurement: Pittsburgh Sleep Quality Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression. Timepoint: 6 days after aromatherapy with Rose and Lavender. Method of measurement: Beck Depression Inventory.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-10</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Dr. Heshmat Hospital - Valiasr Square, Bayani St. rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
