<?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>IRCT20171224038025N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-23</date_registration>
      <primary_sponsor>Bam University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of aromatherapy with essential oils cloves and Citrus Aurantium on pain and anxiety in the first stage of labor in primiparous women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of aromatherapy with essential oils cloves and Citrus Aurantium on pain and anxiety in the first stage of labor in primiparous women referring to Bam Pasteur Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28484</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: To confirm people, three groups of weekly treatments will be used. Six cards of 6 days a week, called perfumes (two cards clove and two card cards Citrus Aurantium and two cards control groups) are prepared from the beginning of each week. A random card No selection choices and the selected fragrances are applied to women on that day.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain and anxiety in the first stage of labor.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first intervention group will consume 0.2 ml of cloves and clot in the collar of the specimens, and every half hour the corresponding essential oil will be repeated. The severity of pain will be measured in dilates of 3-4, 5-7 and 8-10 cm and the severity of anxiety will be measured at dilatation of 3-4 and 8-10 cm. Intervention 2: Intervention group: In the second intervention group, 4 ml of essential oil of Citrus Aurantium  will be attached to the collar of the samples, and every half an hour the prescribed essential oil will be repeated. The severity of pain will be measured in dilates of 3-4, 5-7 and 8-10 cm and the severity of anxiety will be measured at dilatation of 3-4 and 8-10 cm. Intervention 3: Control group: In the third group or control group, 4 ml of normal saline will be gassed and bonded to the collar of the samples, and each half an hour the prescribed essential oil will be repeated. The severity of pain will be measured in dilates of 3-4, 5-7 and 8-10 cm and the severity of anxiety will be measured at dilatation of 3-4 and 8-10 cm.</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:
Data on the outcome of study (pain relief and delivery anxiety)

When:
After completion of the sampling all the consequences are presented in a report

To whom:
Head of Hospital and Research Deputy of Bam University of Medical Sciences

Conditions:
After publishing an article in the internal journal, the results of the research will be provided to individuals upon request by email

Where to obtain:
Author

How to obtain:
Applying from the email or through the university

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahin khajehpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Persian Gulf Blvd.</address>
        <city>Bam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618716519</zip>
        <telephone>+98 34 4421 7378</telephone>
        <email>m.khajehpoor25@gmail.com</email>
        <affiliation>Bam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin khajehpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Persian Gulf Blvd.</address>
        <city>Bam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618716519</zip>
        <telephone>+98 34 4421 7378</telephone>
        <email>m.khajehpoor25@gmail.com</email>
        <affiliation>Bam University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>primiparous</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the first intervention group will consume 0.2 ml of cloves and clot in the collar of the specimens, and every half hour the corresponding essential oil will be repeated. The severity of pain will be measured in dilates of 3-4, 5-7 and 8-10 cm and the severity of anxiety will be measured at dilatation of 3-4 and 8-10 cm</i_keyword>
      <i_keyword>Intervention group: In the second intervention group, 4 ml of essential oil of Citrus Aurantium  will be attached to the collar of the samples, and every half an hour the prescribed essential oil will be repeated. The severity of pain will be measured in dilates of 3-4, 5-7 and 8-10 cm and the severity of anxiety will be measured at dilatation of 3-4 and 8-10 cm.</i_keyword>
      <i_keyword>Control group: In the third group or control group, 4 ml of normal saline will be gassed and bonded to the collar of the samples, and each half an hour the prescribed essential oil will be repeated. The severity of pain will be measured in dilates of 3-4, 5-7 and 8-10 cm and the severity of anxiety will be measured at dilatation of 3-4 and 8-10 cm.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of labor pain. Timepoint: The severity of pain in the first stage of labor is measured at dilates of 3-4, 5-7 and 8-10 cm. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>The amount of labor anxiety. Timepoint: The amount of anxiety in the dilatation is 3-4 and 8-10 cm. Method of measurement: Spielberger Anxiety Inventory.</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>Bam University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-21</approval_date>
        <contact_name>Ethics Committee of Bam University of Medical Sciences</contact_name>
        <contact_address>persian gulf Bam Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
