<?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>IRCT20250226064865N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-15</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of aromatherapy massage using Rosa damascena oil on the severity of pain caused by primary dysmenorrhea in students</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of aromatherapy massage using Rosa damascena oil on the severity of pain caused by primary dysmenorrhea in students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82181</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible individuals will be selected by convenience sampling and then allocated to the intervention and control groups using a 4-block random sampling method.
For this purpose, the 26 blocks of four will be selected using a random number table, resulting in a sample size of 52 individuals per group. Blocking will be performed by a person not involved in the sampling.</study_design>
      <phase>3</phase>
      <hc_freetext>Primary Dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will massage one cc of Rosa damascena Barij essential oil topically onto the pubic for 10 minutes, three times a day, starting two days before the start of menstruation and ending three days after. The massage will be done with the palm of one hand in a back-and-forth motion without additional pressure. Intervention 2: The control group will receive routine treatment, which includes 500 mg of mefenamic acid capsules from the onset of menstrual symptoms until 3 days after.</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 entire data cannot be shared after de-identifying individuals, but some of the information related to the main outcome can be shared.

When:
One year after the results were published

To whom:
Researchers working in academic and scientific institutions

Conditions:
In order to conduct scientific studies
under the conditions of obtaining permission and observing the principles of research ethics

Where to obtain:
Person responsible for scientific accountability of the study

How to obtain:
One year after the article was published

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samineh Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Pharmacy, Zanjan university of Medical Sciences</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۵۱۳۹۵۶۱۸۴</zip>
        <telephone>+98 24 3347 3635</telephone>
        <email>jafari_s@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samineh Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Pharmacy, Zanjan university of Medical Sciences</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۵۱۳۹۵۶۱۸۴</zip>
        <telephone>+98 24 3347 3635</telephone>
        <email>Jafari_s@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Regular menstruation
Primary dysmenorrhea, grade 1 to 2, based on the Verbal Multidimensional Scoring System
Having a normal sense of smell and ability to smell perfumes
Willingness to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Allergy to Rosa damascena
Suspected pregnancy
Use of hormonal contraceptives
The use of other pain relievers except mefenamic acid
History of abnormal uterine bleeding
Having chronic pelvic inflammatory disease
Having systemic diseases
secondary dysmenorrhea
History of pelvic or abdominal surgery
Having an ovarian cyst
Congenital anomalies of the genital tract</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary dysmenorrhea</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>The intervention group will massage one cc of Rosa damascena Barij essential oil topically onto the pubic for 10 minutes, three times a day, starting two days before the start of menstruation and ending three days after. The massage will be done with the palm of one hand in a back-and-forth motion without additional pressure.</i_keyword>
      <i_keyword>The control group will receive routine treatment, which includes 500 mg of mefenamic acid capsules from the onset of menstrual symptoms until 3 days after.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of menstrual pain. Timepoint: In three time periods: 8-13, 13-18 and 18-24 per day for three consecutive cycles. Method of measurement: Visual analog scale.</prim_outcome>
      <prim_outcome>Duration of menstrual pain. Timepoint: In three time periods: 8-13, 13-18 and 18-24 per day for three consecutive cycles. Method of measurement: Total number of hours of pain per cycle.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The need to use drug therapy to reduce pain. Timepoint: The end of each menstrual cycle for three consecutive months. Method of measurement: The number of capsules of mefenamic acid consumed.</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>Elaheh Rahmati</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-20</approval_date>
        <contact_name>Ethics committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Blvd. of Ostad Saboti, Zanjan University of Medical Sciences,Zanjan Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
