<?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>IRCT20221227056938N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-10</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of rose oil on insomnia and sleep quality of students</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of rose oil on insomnia and sleep quality of students living in the girls' dormitory</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71709</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation, people are divided into two groups A and B using a random table, Blinding description: Rose oil and placebo oil will be made by the pharmacist and both rose oil and placebo will be coded (A, B). For the preparation of medicines, 40 bottles with rose oil from the company and another 40 bottles will be prepared by the placebo substance and will be filled with the same color and shape as rose oil. Roses prepared from Attari are put in olive oil at a ratio of 4 times olive oil to roses for 48 hours in a greenhouse, then strained and this is done 3 times. Also, the placebo is paraffin oil, we grease the wall of the paraffin oil can with 5ppm of rose essential oil. Study at the patient level, the outcome evaluator and the statistical analyst of the results will be blinded. Before being filled, the drug and placebo bottles are divided into two equal groups of 40 numbers based on the random number table in the blocky method, and then based on the results obtained, the bottles are filled with drug essence or placebo. Only the researcher can decipher the contents of each bottle based on the initial form of the randomization results. The research unit and the researcher will not be aware of the type of medicine in the Kedar bottles. Finally, the researcher will deliver the coded drugs to the students and give them the necessary training on how to use them.</study_design>
      <phase>3</phase>
      <hc_freetext>insomnia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  receiving rose oil .. Rose oil and placebo oil will be made by the pharmacist and both rose oil and placebo will be coded (A, B). For the preparation of medicines, 40 bottles will be filled with rose oil. Roses prepared from Attari in olive oil at a ratio of 4 times olive oil to roses are placed in a greenhouse for 48 hours, then strained and this is done 3 times. Massage 5 drops on your forehead once a day before going to bed for a week. Intervention 2: Control group:  another 40 bottles will be prepared by the placebo substance and will be filled with the same color and shape with rose oil. The placebo is paraffin oil, we grease the wall of the paraffin oil can with 5ppm of rose essential oil. Massage the bottle containing 3 to 5 drops of oil on your forehead once a day before going to bed for a week.</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:
It is published as an article.

When:
After completing the study

To whom:
all people

Conditions:
article

Where to obtain:
Correspond

How to obtain:
email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naghmeh Yazdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>karegar</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794 - 61357</zip>
        <telephone>+98 916 311 9228</telephone>
        <email>naghmehyazdi@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naghmeh Yazdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794 - 61357</zip>
        <telephone>+98 916 311 9228</telephone>
        <email>naghmehyazdi@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A female student living in the dormitory
Iranian
Having a sleep disorder and insomnia with the Pittsburgh Questionnaire
Willingness to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>36 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a specific disease including depression, anxiety and migraine headaches
Taking drugs affecting sleep in the last two weeks, such as sleeping pills
Allergy to rose
A person's refusal to continue participating in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G47.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Insomnia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  receiving rose oil .. Rose oil and placebo oil will be made by the pharmacist and both rose oil and placebo will be coded (A, B). For the preparation of medicines, 40 bottles will be filled with rose oil. Roses prepared from Attari in olive oil at a ratio of 4 times olive oil to roses are placed in a greenhouse for 48 hours, then strained and this is done 3 times. Massage 5 drops on your forehead once a day before going to bed for a week.</i_keyword>
      <i_keyword>Control group:  another 40 bottles will be prepared by the placebo substance and will be filled with the same color and shape with rose oil. The placebo is paraffin oil, we grease the wall of the paraffin oil can with 5ppm of rose essential oil. Massage the bottle containing 3 to 5 drops of oil on your forehead once a day before going to bed for a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Insomnia or lack of sleep is a symptom that a person does not fall asleep continuously. In other words, difficulty in falling asleep, waking up repeatedly during the night with inability or difficulty in falling asleep again, waking up very early in the morning and sleep that does not rejuvenate are called insomnia. Timepoint: The beginning and end of the study. Method of measurement: Pittsburgh 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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-10</approval_date>
        <contact_name>Research Committee of Jundishapur University of Medical Sciences, Ahvaz</contact_name>
        <contact_address>Ahvaz, academic city, next to the central organization of Jundishapur University of Medical Sciences and Healthcare Services, Ahvaz, Vice-Chancellor of Research and Technology Development Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
