<?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>IRCT20230502058052N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-08</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of aromatherapy with rosa damascena, lavender and citrus aurantium essential oils on the severity of premenstrual syndrome symptoms</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of aromatherapy with rosa damascena, lavender and citrus aurantium essential oils on the severity of premenstrual syndrome symptoms in married women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69921</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The random allocation of samples to each of the studied groups will be determined using 4 and 8 variable blocks and a computer program. Sealed sealed envelopes will be numbered sequentially and used to conceal the allocation, Blinding description: Essential oils and placebo in identical bottles in terms of packaging shape and color; and are coded with A, B, C and D codes; And the study will be blinded in terms of research units.</study_design>
      <phase>3</phase>
      <hc_freetext>Premenstrual Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: From 7 days before menstruation to the fourth day of menstrual bleeding, for two cycles, every day, 2 times a day, 10 drops of 30% rosa damascena essential oil were dripped on a piece of cotton and from a distance of 10 cm from the nose for 5 minutes with they inhale normally. Intervention 2: Intervention group: From 7 days before menstruation to the fourth day of menstrual bleeding, for two cycles, every day, 2 times a day, 10 drops of 30% lavender essential oil were dripped on a piece of cotton and from a distance of 10 cm from the nose for 5 minutes with they inhale normally. Intervention 3: Intervention group: From 7 days before menstruation to the fourth day of menstrual bleeding, for two cycles, every day, 2 times a day, 10 drops of 30% citrus aurantium essential oil were dripped on a piece of cotton and from a distance of 10 cm from the nose for 5 minutes with they inhale normally. Intervention 4: control group: From 7 days before menstruation to the fourth day of menstrual bleeding, for two cycles, every day, 2 times a day, drip 10 drops of odorless sweet almond oil on a piece of cotton and hold it from a distance of 10 cm from the nose for 5 minutes with they inhale normally.</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:
The participants are coded to increase access to them and their information, but at the time of publication, only the main result is published and the information of the participants is not published in any way.

When:
6 months after the results are published

To whom:
Access is open to the public

Conditions:
If people have a request, without mentioning the coding of the information confidentially, without the personal information of the people, only the main and side results will be provided to the requester.

Where to obtain:
E-mail

How to obtain:
First, the applicant sends a message to the e-mail and explains the reason for using the data, and within a week, information with conditions and restrictions will be sent to the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Rastegar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>On the side of Asian Road, Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 991 173 9624</telephone>
        <email>maahsaa.rastegarr@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahsa Rastegar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>On the side of Asian Road, Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 991 173 9624</telephone>
        <email>maahsaa.rastegarr@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Age range from 18 to 35 years
Normal body mass index
No smoking and drugs
Absence of medical diseases and disorders related to the reproductive system based on the person's statements
Not suffering from psychiatric diseases, anxiety disorders, depression and stress based on the person's statements
Menstrual cycles of 21-35 days with a duration of 4-8 days
Having moderate or severe premenstrual syndrome based on the PSST questionnaire
Not using drugs or supplements effective on premenstrual syndrome from 2 months before the start of the study
Not doing sports professionally
No stressful event in the last 6 months
No disorder in the olfactory system based on the person's statements</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue cooperation
Changes in the intervals of menstrual cycles (less than 21 days and more than 35 days) and the number of menstrual days (less than 4 days and more than 8 days)
Taking drugs and supplements effective on premenstrual syndrome
Allergy to the essential oils used in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Premenstrual tension syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: From 7 days before menstruation to the fourth day of menstrual bleeding, for two cycles, every day, 2 times a day, 10 drops of 30% rosa damascena essential oil were dripped on a piece of cotton and from a distance of 10 cm from the nose for 5 minutes with they inhale normally.</i_keyword>
      <i_keyword>Intervention group: From 7 days before menstruation to the fourth day of menstrual bleeding, for two cycles, every day, 2 times a day, 10 drops of 30% lavender essential oil were dripped on a piece of cotton and from a distance of 10 cm from the nose for 5 minutes with they inhale normally.</i_keyword>
      <i_keyword>Intervention group: From 7 days before menstruation to the fourth day of menstrual bleeding, for two cycles, every day, 2 times a day, 10 drops of 30% citrus aurantium essential oil were dripped on a piece of cotton and from a distance of 10 cm from the nose for 5 minutes with they inhale normally.</i_keyword>
      <i_keyword>control group: From 7 days before menstruation to the fourth day of menstrual bleeding, for two cycles, every day, 2 times a day, drip 10 drops of odorless sweet almond oil on a piece of cotton and hold it from a distance of 10 cm from the nose for 5 minutes with they inhale normally</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Symptoms of premenstrual syndrome. Timepoint: before the start of the intervention and during the intervention in two menstrual cycles. Method of measurement: Premenstrual syndrome symptoms screening 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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-30</approval_date>
        <contact_name>Ethics Committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>On the side of Asian Road, Gonabad University of Medical Sciences Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
