<?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>IRCT20210809052128N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-21</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of lavender and Rosa-damascena on sleep quality</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of lavender and Rosa-damascena on sleep quality of pre-hospital emergency staff</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61539</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done using a table of random numbers. The numbers 0 to 49 will be considered for the first intervention group, 50 to 99 for the second intervention group, and 100 to 149 for the control group. The researcher will randomly put a hand on one of the numbers and move in one of the predetermined paths, then record the numbers and assign the individuals to the groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Sleep disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In intervention group 1 (aromatherapy with Lavender), the method of intervention will be that the person pours two drops of the solution into the vial using a dropper on a cotton ball or paper towel and puts it at a distance of 15 to 20 cm from his nose. He takes a deep breath for two minutes and does this every other night for four weeks in the absence of shifts and at home. Due to the fact that this intervention is performed by the individual, the experimental group will give a vial of Lavender with a concentration of 2% (produced by Kashan Barij Essential Oil Company) to each of the samples. Intervention 2: Intervention group: Intervention group: In intervention group 2 (aromatherapy with Rosa-damascena), the method of intervention will be that the person pours two drops of the solution into the vial using a dropper on a cotton ball or paper towel and puts it at a distance of 15 to 20 cm from his nose. He takes a deep breath for two minutes and does this every other night for four weeks in the absence of shifts and at home. Due to the fact that this intervention is performed by the individual, the experimental group will give a vial of Rosa-damascena with a concentration of 2% (produced by Kashan Barij Essential Oil Company) to each of the samples. Intervention 3: Control group: In Control group (water), the method of intervention will be that the person pours two drops of the solution into the vial using a dropper on a cotton ball or paper towel and puts it at a distance of 15 to 20 cm from his nose. He takes a deep breath for two minutes and does this every other night for four weeks in the absence of shifts and at home. Due to the fact that this intervention is performed by the individual, the experimental group will give a vial of water to each of the samples.</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:
Data on demographic information and patient pain are distributed as anonymous codes

When:
Starting data access is from 2022

To whom:
Access to data will be free for anyone interested in research

Conditions:
Granting data for scientific use without fringe is allowed

Where to obtain:
Can contact with a.noyani@shmu.ac.ir email

How to obtain:
About a month from the time of the first call through the email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh Mahvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv. Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00988338279394</zip>
        <telephone>+98 83 3835 8258</telephone>
        <email>mandanamahvar@ yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tayebeh Mahvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv. Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00988338279394</zip>
        <telephone>+98 83 3835 8258</telephone>
        <email>mandanamahvar@ yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have at least one year of work experience
Have the health of the sense of smell
No underlying sleep-related illnesses (such as rheumatoid arthritis and migraines),
No known sleep disorders as reported by the patient (hospitalization, sleep-related medications)
No history of allergic asthma or rhinitis
No history of flower allergies, and Herbs and the smell of sweat and their essential oils
Not taking neuroleptic drugs
Not having vision problems and
Not having a care or treatment plan during sleep hours
lack of respiratory problems</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Arbitrary use of sedatives
Severe sensitivity to the scent of Rosa-damascena or lavender and</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G47</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sleep disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In intervention group 1 (aromatherapy with Lavender), the method of intervention will be that the person pours two drops of the solution into the vial using a dropper on a cotton ball or paper towel and puts it at a distance of 15 to 20 cm from his nose. He takes a deep breath for two minutes and does this every other night for four weeks in the absence of shifts and at home. Due to the fact that this intervention is performed by the individual, the experimental group will give a vial of Lavender with a concentration of 2% (produced by Kashan Barij Essential Oil Company) to each of the samples.</i_keyword>
      <i_keyword>Intervention group: Intervention group: In intervention group 2 (aromatherapy with Rosa-damascena), the method of intervention will be that the person pours two drops of the solution into the vial using a dropper on a cotton ball or paper towel and puts it at a distance of 15 to 20 cm from his nose. He takes a deep breath for two minutes and does this every other night for four weeks in the absence of shifts and at home. Due to the fact that this intervention is performed by the individual, the experimental group will give a vial of Rosa-damascena with a concentration of 2% (produced by Kashan Barij Essential Oil Company) to each of the samples.</i_keyword>
      <i_keyword>Control group: In Control group (water), the method of intervention will be that the person pours two drops of the solution into the vial using a dropper on a cotton ball or paper towel and puts it at a distance of 15 to 20 cm from his nose. He takes a deep breath for two minutes and does this every other night for four weeks in the absence of shifts and at home. Due to the fact that this intervention is performed by the individual, the experimental group will give a vial of water to each of the samples.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality. Timepoint: Before intervention and four weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-27</approval_date>
        <contact_name>Ethic Committee of Kermanshah University of Medical Science</contact_name>
        <contact_address>Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.Kermashah,iran Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
