<?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>IRCT20120414009463N62</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-18</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>evaluation the effect of citrus aurantium on severity of primary dysmenorrhea in two models of skin massage and inhalation aromatherapy</public_title>
      <acronym></acronym>
      <scientific_title>evaluation the effect of citrus aurantium on severity of primary dysmenorrhea in two models of skin massage and inhalation aromatherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54310</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be done with the consecutive presence of the researcher in the dormitories of Zanjan University of Medical Sciences in two stages. At first  two dormitories of Zanjan University of Medical Sciences will be divided into two groups of massage therapy and inhalation aromatherapy with using of lottery card . Then in the first stage, people who have dysmenorrhea and met inclusion criteria   and want to participate in the study will be determined, and then They will be randomly assigned to the intervention and control group within each dormitory. Randomization  will be done by  using  the website Randomization with www.graphpad.com. Initially, inside each dormitory, people who met inclusion criteria were given the number one to 70, and with using web-based randomization will placed in two groups of massage therapy with citrus aurantium essential  oil and massage with sweet almond oil, and in the another dormitory in two groups of inhalation aromatherapy of citrus aurantium essential  oil and  sweet almond oil. The number B is written on the bottles of almond oil and the number A is written on the bottle containing of citrus aurantium essential  oil.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Primary dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the study who met the inclusion criteria in the In massage group,  massage will be done in the first two days of the menstrual cycle daily for 30 minutes with 2cc of citrus aurantium essential oil for two consecutive cycles  and In the aromatherapy group, in the first two days of the menstrual cycle for two consecutive cycles, 10 drops of citrus aurantium essential oil are sprayed on the piece of cotton and inhaled at a distance of 20 cm from the nose for 30 minutes. Intervention 2: Control group: Participants in the study who met the inclusion criteria in the In massage group,  massage will be done in the first two days of the menstrual cycle daily for 30 minutes with 2cc of sweet almond oil for two consecutive cycles  and In the aromatherapy group, in the first two days of the menstrual cycle for two consecutive cycles, 10 drops of sweet almond oil are sprayed on the piece of cotton and inhaled at a distance of 20 cm from the nose for 30 minutes.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I have not decided yet - the release schedule is not clear yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Behboodi Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4227</telephone>
        <email>Behboodi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Behboodi Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4227</telephone>
        <email>Behboodi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>satisfaction to participate in the study
having a regular menstrual cycle with a duration of 3-7 days and interval of 21-35 days
menarche before the age of 18
primary dysmenorrhea with a score of 5 or more in the visual Analogue scale During two consecutive cycles
age 18-25 years
single
Iranian
lack of mental or physical illness
absence of gynecological disease (myoma, endometriosis, ovarian cyst, pelvic inflammatory disease, etc.)
having a normal sense of smell</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue attending the study
very severe dysmenorrhea
incidence of dysmenorrhea after the age of 20
allergy to citrus aurantium essential oil
diagnosis of physical or mental illness during the study
abnormal bleeding during the study</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>Intervention group: Participants in the study who met the inclusion criteria in the In massage group,  massage will be done in the first two days of the menstrual cycle daily for 30 minutes with 2cc of citrus aurantium essential oil for two consecutive cycles  and In the aromatherapy group, in the first two days of the menstrual cycle for two consecutive cycles, 10 drops of citrus aurantium essential oil are sprayed on the piece of cotton and inhaled at a distance of 20 cm from the nose for 30 minutes.</i_keyword>
      <i_keyword>Control group: Participants in the study who met the inclusion criteria in the In massage group,  massage will be done in the first two days of the menstrual cycle daily for 30 minutes with 2cc of sweet almond oil for two consecutive cycles  and In the aromatherapy group, in the first two days of the menstrual cycle for two consecutive cycles, 10 drops of sweet almond oil are sprayed on the piece of cotton and inhaled at a distance of 20 cm from the nose for 30 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of people whose menstrual pain intensity has decreased after abdominal massage of citrus aurantium  oil or inhalation of citrus aurantium essential oil. Timepoint: Before the intervention, after the intervention in the first cycle and after the intervention in the second cycle in the control and intervention groups. Method of measurement: visual analogue scale tool.</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>معاونت پژوهشی دانشگاه علوم پزشکی تهران</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-02</approval_date>
        <contact_name>Ethics committee of tehran university of medical science</contact_name>
        <contact_address>Keshavarz Boulevard, corner of Quds Street, central building tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
