<?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>IRCT20230220057463N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-04</date_registration>
      <primary_sponsor>Iranshahr University of Medical Sciences</primary_sponsor>
      <public_title>The effect of  Lavandula  Essence on the severity of premenstrual syndrome (PMS) symptoms in students of Iranshahr University of Medical Sciences 1401</public_title>
      <acronym></acronym>
      <scientific_title>The effect of  Lavandula  Essence on the severity of premenstrual syndrome (PMS)  in students.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/68933</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this way, according to the sample size, 80 cards were prepared, 40 cards with the letter A on it and 40 cards with the letter B written on it and placed in a container. All eligible students choose one of the cards, card A will be the intervention group and card B will be the control group, Blinding description: The groups are provided to the analyzer as A and B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premenstrual syndrome symptoms.</hc_freetext>
      <i_freetext>Intervention 1: "Aromatherapy with lavender essential oil will be performed by the participants themselves, twice a day, with 3 drops of lavender essential oil, from 7 days before menstruation until the fourth day of menstruation (11 days total). In this study, 3 drops of lavender essential oil will be added to 200 mL of hot water; then, the participant's head will be covered with a towel while seated, and she will inhale the steam. This intervention will be carried out for 2 months. Intervention 2: Control group: In the control group, almond oil will be administered by the participants themselves twice daily, with 3 drops, starting 7 days before menstruation and continuing until the fourth day of menstruation (total of 11 days). In this study, 3 drops of almond oil will be added to 200 mL of hot water; then, the participant's head will be covered with a towel while seated, and she will inhale the steam. This placebo intervention will be carried out for 2 months in the control group.</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:
Primary outcomes of the study: premenstrual syndrome (PMS) symptoms"

When:
After the results are published"

To whom:
Researchers worldwide

Conditions:
If requested"

Where to obtain:
the corresponding author

How to obtain:
Applicants must submit a written request to the corresponding author after publication of the results. The request should include the applicant's name, institutional affiliation, purpose of access, and the specific data required. After approval by the research team, de-identified (coded) data will be sent via email. The entire process, from receipt of the request to data submission, is expected to take approximately 2 to 4 weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arezoo pirak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fath Moradi Highway - Faculty of Medicine</address>
        <city>Iranshahar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9914786138</zip>
        <telephone>+98 54 3721 0483</telephone>
        <email>pirak.arezoo@yahoo.com</email>
        <affiliation>Iranshahr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arezoo pirak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fath Moradi Highway - Faculty of Medicine</address>
        <city>Iranshahar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9914786138</zip>
        <telephone>+98 54 3721 0483</telephone>
        <email>pirak.arezoo@yahoo.com</email>
        <affiliation>Iranshahr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having regular menstruation (21-35 days),
not taking antidepressants in the last few months, not taking hormonal and vitamin drugs</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diagnosis of depression (with standard Beck questionnaire),
the occurrence of events such as the death of relatives, divorce and other unfortunate events,
occurrence of menstrual disorders during the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Aromatherapy with lavender essential oil will be performed by the participants themselves, twice a day, with 3 drops of lavender essential oil, from 7 days before menstruation until the fourth day of menstruation (11 days total). In this study, 3 drops of lavender essential oil will be added to 200 mL of hot water; then, the participant's head will be covered with a towel while seated, and she will inhale the steam. This intervention will be carried out for 2 months.</i_keyword>
      <i_keyword>Control group: In the control group, almond oil will be administered by the participants themselves twice daily, with 3 drops, starting 7 days before menstruation and continuing until the fourth day of menstruation (total of 11 days). In this study, 3 drops of almond oil will be added to 200 mL of hot water; then, the participant's head will be covered with a towel while seated, and she will inhale the steam. This placebo intervention will be carried out for 2 months in the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of premenstrual syndrome symptoms. Timepoint: 7 days before menstruation and the first 4 days of menstruation. Method of measurement: Premenstrual Symptoms Questionnaire (PSST).</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>Iranshahr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-23</approval_date>
        <contact_name>Ethics committee of Iranshahr  University of Medical Sciences</contact_name>
        <contact_address>Baluch Blvd.- Roozbeh Psychiatric Hospital- Deputy Research and Technology Iranshahr Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
