<?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>IRCT20170906036081N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-15</date_registration>
      <primary_sponsor>The University of Kurdistan of Medical Science</primary_sponsor>
      <public_title>Effect of Entonox gas compared with aromatherapy with Lavender on severity of labor pain</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Entonox gas compared with aromatherapy with Lavender on severity of nulliparous women's labor pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27080</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: People wlli divide randomly divided into intervention and control groups.
The placement of individuals in the interventions grope on the envelope is designed so that people will have equal odds, Blinding description: To prevent bias, the researcher will not measure the severity of pain after the intervention, and this will be done by a research collaborator.
Information will be provided to the analyst without specifying intervention groups.
Due to the LDR of the research room rooms, the patient is unaware of the interventional groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Severity of labor pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the group using Entonox gas, people will be trained to breathe the mask on their mouths, starting with a 4 cm dilatation.They should tell their severity before and after the use of Entonx gas based on the visual analogue scale ruler (VAS). The amount of pain will be recorded.  Measuring the pain at dilates of 5-4 cm, 7-6 cm, 9-8 cm and 10 cm before and after using the entonox gas. Intervention 2: Intervention group : In a group of lavender fragrances, after 4 cm dilatation, the researcher will drop two drops of lavender essential oil prepared by Barich Essence on sterilized gas at a distance of 7-10 cm from the patient's nose. And every half an hour it will repeat the essential oil on the gas. The mother should tell her pain before and after the intervention based on the visual criteria of the VAS ruler in dilatations of 5-4 cm, 7-6 cm, 9-8 cm and 10 cm. This information will be recorded by the research fellow.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maedeh Sharghi Chalaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Blvd, Kurdistan University of Medical Science</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618634683</zip>
        <telephone>+98 87 3323 5445</telephone>
        <email>maedeh.sharghi@muk.ac.ir</email>
        <affiliation>The University of Kurdistan of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maedeh Sharghi Chalaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Blvd, Kurdistan University of Medical Science</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618634683</zip>
        <telephone>+98 87 3323 5445</telephone>
        <email>maedeh.sharghi@muk.ac.ir</email>
        <affiliation>The University of Kurdistan of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 35 to 18 can enter the study.
Women who are nulliparous can participate in the study.
The position of the embryo should be cephalic.
Amenotypic fluid volume of the mother is normal.
The last trimester of ultrasound has reported the normal weight of the fetus.
According to the first day of the last menstruation, the gestational age is greater than 38 weeks.
The mother is healthy in terms of respiratory system and smell.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Hypertension in mother .
Diabetes in mother.
The mother has thyroid problems.
The embryo is macrosomal.
The fetus is a IUGR or low birth weight .
Long-term rupture of the curtains for more than 18 hours.
Polyhydramnios
Oligohydramnios
Embryonic anomalies have been diagnosed.
Mothers have allergies and respiratory illness.
An uncontrollable heartbeat of the fetus is created in the lab.
SPO2 mother is less than 95%
People who have contraindications to Entonox gas, such as head trauma, head stiffness, severe asthma, need for medical interventions in labor, are excluded from 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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the group using Entonox gas, people will be trained to breathe the mask on their mouths, starting with a 4 cm dilatation.They should tell their severity before and after the use of Entonx gas based on the visual analogue scale ruler (VAS). The amount of pain will be recorded.  Measuring the pain at dilates of 5-4 cm, 7-6 cm, 9-8 cm and 10 cm before and after using the entonox gas.</i_keyword>
      <i_keyword>Intervention group : In a group of lavender fragrances, after 4 cm dilatation, the researcher will drop two drops of lavender essential oil prepared by Barich Essence on sterilized gas at a distance of 7-10 cm from the patient's nose. And every half an hour it will repeat the essential oil on the gas. The mother should tell her pain before and after the intervention based on the visual criteria of the VAS ruler in dilatations of 5-4 cm, 7-6 cm, 9-8 cm and 10 cm. This information will be recorded by the research fellow.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of labor pain. Timepoint: The severity of pain is measured in dilates 4-5, 6-7, 8-9, and 10 cm before and after the intervention. Method of measurement: Visual Analogue Scale.</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>The University of Kurdistan of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-05</approval_date>
        <contact_name>ethics committee of kurdistan university of medical sciences</contact_name>
        <contact_address>Pasdaran street، Kurdistan University of Medical Science Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
