<?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>IRCT2017012323370N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-23</date_registration>
      <primary_sponsor>Vice chancellor for research, Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>effect of aromatherapy on pain, anxiety and duration of first and second stages of labor</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of Comparison The effect of aromatherapy with essential oil of Rosa damascene and lavender in the single and mixed from on pain, anxiety and duration of first and second stages of labor in primigravida women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19941</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pain and anxiety and duration of first and second stages of labor.</hc_freetext>
      <i_freetext>Intervention 1: On the nulliparous women with VAS pain intensity and anxiety level were assessed by questionnaire "Eshpel Burger"  into four groups and then intervention was divided into three groups as below. The first group inhaled 0.1 ml rose  mixed with 2 ml of distilled water, the second group inhaled 0.1 ml of lavender oil mixed with 2 ml of distilled water, the third group inhaled 0.1 ml Rose and 0.1 ml of lavender oil mixed with 2 ml of distilled water. Then poured oil on the guate and clipped to the collars of the women and asked them to inhale their fragrance during uteral contractions. Pain intensity  and anxiety level were measured again 30 and 60 minutes after the intervention. The duration of the first stage and second stage were measured and recorded by the researcher. Intervention 2: In the control group ,placebo or normal saline (N/S) was used in the place of oil so that in the active phase of the Labour two drops of saline is poured on the threaded guates. pain intensity is  measured by VAS and the anxiety level by questionnaire "Eshpel Burger" 30 and 60 minutes after intervention was measured. The duration of the first and second stage were measured and recorded by the researcher.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Navaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behdasht Street, Zahedan, Iran</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 54 3344 4510</telephone>
        <email>helennavaee@gmail.com</email>
        <affiliation>Faculty of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Navaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behdasht Street, Zahedan, Iran</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 54 3344 4510</telephone>
        <email>helennavaee@gmail.com</email>
        <affiliation>Faculty of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criterias:Age between 18-35; Normal pregnancy between 42-38 weeks; Cephalic presentation; Normal fetus and  amniotic fluid index; Singleton pregnancy; Dilatation of the cervix 3-4 cm, At least the fifth class of the primary education and no history of infertility;The absence of acute and chronic diseases; Asthma, eczema and allergies;  Lack of anxiety and known  depression diseases;  Not taking anti-anxiety drugs; No addiction to narcotic drugs; Since last six months had no severe emotional disorders; And they shouldn't be from the medical staff. &#13;
 Exclusion criterias: Receiving analgesics; Sedatives and narcotics drugs with in three hours of the beginning and during the study; Use of oxytocin for induction and augmentation of Labour; All mothers who were discharged the natural course of Labour and were in need of intensive care or emergency cesarean section, Or had allergy to the used material.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O60-75</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complications of labour and delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>On the nulliparous women with VAS pain intensity and anxiety level were assessed by questionnaire "Eshpel Burger"  into four groups and then intervention was divided into three groups as below. The first group inhaled 0.1 ml rose  mixed with 2 ml of distilled water, the second group inhaled 0.1 ml of lavender oil mixed with 2 ml of distilled water, the third group inhaled 0.1 ml Rose and 0.1 ml of lavender oil mixed with 2 ml of distilled water. Then poured oil on the guate and clipped to the collars of the women and asked them to inhale their fragrance during uteral contractions. Pain intensity  and anxiety level were measured again 30 and 60 minutes after the intervention. The duration of the first stage and second stage were measured and recorded by the researcher.</i_keyword>
      <i_keyword>In the control group ,placebo or normal saline (N/S) was used in the place of oil so that in the active phase of the Labour two drops of saline is poured on the threaded guates. pain intensity is  measured by VAS and the anxiety level by questionnaire "Eshpel Burger" 30 and 60 minutes after intervention was measured. The duration of the first and second stage were measured and recorded by the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: At the beginning of the active phase and before the intervention and again after giving birth. Method of measurement: With anxiety inventory Spillberger.</prim_outcome>
      <prim_outcome>Pain. Timepoint: 30 and 60 minutes after intervention. Method of measurement: Using a numerical pain scale (VAS).</prim_outcome>
      <prim_outcome>First stages of labor. Timepoint: Once and from the beginning to the end of the active phase. Method of measurement: using a researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Second stages of labor. Timepoint: Once and from the beginning to the end of the active phase. Method of measurement: Using a researcher-made questionnaire.</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>Vice chancellor for research, Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-13</approval_date>
        <contact_name>Vice chancellor for research, Zahedan University of Medical Sciences</contact_name>
        <contact_address>Zahedan University of Medical Sciences, Khalije Fars Boulevard, Zahedan, Ira Zahedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
