<?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>IRCT20250531065989N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-09-27</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>The effect of abdominal massage with Rosemary oil on the intensity of menstrual pain and bleeding</public_title>
      <acronym></acronym>
      <scientific_title>The effect of abdominal massage with Rosemary oil on the intensity of menstrual pain and bleeding</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83947</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method in this study is convenience sampling, and participants are divided into two intervention and control groups using block randomization. Block randomization is an important method in clinical trial design that is used to balance the number of participants in different treatment groups, reduce bias, and increase the validity of the results. This method is particularly useful in randomized controlled trials (RCTs) and helps researchers ensure that there are equal numbers of participants in each treatment group. The method is that participants are randomly divided into blocks. Each block contains a number of participants who are assigned to different treatment groups, so that each group has an equal number of participants. In this study, computer algorithms will be used to randomly assign blocks to consider additional parameters and ensure appropriate allocation of participants to groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Intensity of menstrual pain and bleeding.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, in the first 3 days of menstruation, the abdomen area, the upper part of the mons pubis, and the area around the navel are massaged twice a day by Shiatsu method by the participant, with 2 cc of 1% rosemary oil based on sunflower oil made by Barich Essence Company, in the form of circular hand movements (without pressure), for 15 minutes, in a lying position. Intervention 2: Control group: In the control group, in the first 3 days of menstruation, 2 times a day, the participant massages the abdominal area, the upper part of the mons pubis, and the area around the navel using Shiatsu method, with 2 cc of sunflower oil manufactured by Barich Essence Company, in the form of circular hand movements (without applying pressure), for 15 minutes, in a lying position.</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 use of the entire content of the resulting article is permitted, provided that the source is properly cited.

When:
Immediately after the article is published

To whom:
The use of the materials in this project and article is free for all domestic and foreign researchers, provided the source is cited.

Conditions:
If the source of the article resulting from this project and the organizational affiliation of the authors of the article are correctly cited, its content may be used in other articles and research projects without hindrance.

Where to obtain:
Vice President for Research and Technology, Qom University of Medical Sciences: Address: Qom - Safashar Street - Jahad Daneshgahi Alley - Shahid Lotfi Niasar (Alley No. 4) - No. 83
Contact Number: 02532852720

How to obtain:
Approval by the Council of the Midwifery Department of Qom University of Medical Sciences and later, approval by the Research and Postgraduate Education Council of the Faculty of Nursing and Midwifery, then: approval by the University Research Council and later, approval by the Ethics Committee of Qom University of Medical Sciences.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahla Hasanzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baran Building 3, Eastern Ponk St, facing Moalem Blvd, South Yas Town</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3197918282</zip>
        <telephone>+98 26 3465 3520</telephone>
        <email>mahlahasanzadeh797979@gmail.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Mehran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, East No 2 Alley, Teacher Blvd, Qom</address>
        <city>Ghoum</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3715835155</zip>
        <telephone>+98 25 3783 1370</telephone>
        <email>n_mehran59@yahoo.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 25 years
Being single
The normality of menstrual cycles (the length of menstrual bleeding is 3 to 8 days and the length of the menstrual cycle is 21 to 35 days)
moderate menstrual pain (getting a score of 4 to 7 according to the visual analogue scale)
Menstrual bleeding score less than 100 according to Higham chart</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Routine use of painkillers in previous menstrual cycles
Using drugs such as anticoagulants, oral contraceptives, narcotics and benzodiazepines
Chronic diseases (irritable bowel syndrome, inflammatory bowel and chronic pelvic pain) and women's diseases (myoma, fibrocystadenoma, endometriosis, chronic pelvic inflammatory disease, congenital abnormalities of the uterus, ovarian cyst, adenomyosis and metrorrhagia) affecting the results of the study
Having skin diseases such as eczema and inflammation in the massage area
Presence of abnormal vaginal secretions
Existence of stressful factors in the last two months (death of relatives, accident, separation from spouse, etc.)
Graduation within the next 6 months
Having a history of allergy to rosemary and sunflower</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, in the first 3 days of menstruation, the abdomen area, the upper part of the mons pubis, and the area around the navel are massaged twice a day by Shiatsu method by the participant, with 2 cc of 1% rosemary oil based on sunflower oil made by Barich Essence Company, in the form of circular hand movements (without pressure), for 15 minutes, in a lying position.</i_keyword>
      <i_keyword>Control group: In the control group, in the first 3 days of menstruation, 2 times a day, the participant massages the abdominal area, the upper part of the mons pubis, and the area around the navel using Shiatsu method, with 2 cc of sunflower oil manufactured by Barich Essence Company, in the form of circular hand movements (without applying pressure), for 15 minutes, in a lying position.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Menstrual pain intensity score according to the visual analog scale. Timepoint: Measuring the intensity of menstrual pain before the start of the study as a baseline score and in the next two menstrual cycles in two consecutive months after the intervention. Method of measurement: 10-point Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Severity of menstrual bleeding based on Higham chart. Timepoint: Measuring the intensity of menstrual bleeding before the start of the study as a baseline score and in the next two menstrual cycles in two consecutive months after the intervention. Method of measurement: Higham chart.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Non. Timepoint: -. Method of measurement: -.</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>Ghoum University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-05</approval_date>
        <contact_name>Ethics committee of Qom university of medical sciences</contact_name>
        <contact_address>Safashahr Ave, Qom Ghoum Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
