<?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>IRCT20180513039632N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-09</date_registration>
      <primary_sponsor>Zabol University of Medical Sciences</primary_sponsor>
      <public_title>Studying the Effect of Aromatherapy on Pain and Anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Comparision of the effects of aromatherapy with roses and lavender ecxtract on pain and anxiety of active phase of labor in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31252</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: Simple randomization.
Random unit: Individual.
Instrumentation: Using colored cards.
How to make sequences: random, Blinding description: All interventions in this research are done by the researcher and the information registration form and the pain assessment scale are completed by another person who are not aware of the type of intervention used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Labor pain. Condition 2: anxiety.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Rose concentration 1%, produced by Barij Essen Company. In the rose group a piece of cloth was impregnated with 0.2 ml of the rose oil and was attached to the collar of the patients and patient inhaled the rose smell. This process starts from the onset of the labor active phase and was repeated every 15 minutes. Intervention 2: Intervention group 2:  The lavender concentration produced by Barij Essen. That was prepared by distillation method with concentration of 1.5% of unopened flowers and olive oil was used as the carrier. In this group, a piece of cloth was impregnated with 0.2 ml of the rose oil and was attached to the collar of the patients and patient inhaled the rose smell. This process starts from the onset of the labor active phase and was repeated every 15 minutes. Intervention 3: Control group: Distilled water.A drop of distilled water was stacked on a piece of cloth and was attached to the patient's collar. The process was repeated every 15 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The main consequences will be published in the article

When:
2018

To whom:
Researchers working in academia

Conditions:
For scientific research

Where to obtain:
Sanaz Nehbandani. snehbandani2013@zbmu.ac.ir

How to obtain:
After getting permission from relevant individuals, there is the possibility of sending data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sanaz Nehbandani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 8,Taleghani 47, Taleghani street</address>
        <city>Zabol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861784678</zip>
        <telephone>+98 54 3222 8046</telephone>
        <email>snehbandani2013@gmail.com</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sanaz Nehbandani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 8,Taleghani 47, Taleghani street</address>
        <city>Zabol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861784678</zip>
        <telephone>+98 54 3222 8046</telephone>
        <email>snehbandani2013@gmail.com</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gestational age of 38-42  week
Being at the age of 18-35 years
Cervical dilatation of more than 3 CM
Singleton pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of asthma and allergies
Known liver, gallbladder and respiratory tract disease
Complications during pregnancy and maternity
Olfactory problems and sensitivity to herbal medicine
Anxiety and depression
History of infertility and especially thyroid disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>000-099</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>080-084</hc_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>First intervention group: Rose concentration 1%, produced by Barij Essen Company. In the rose group a piece of cloth was impregnated with 0.2 ml of the rose oil and was attached to the collar of the patients and patient inhaled the rose smell. This process starts from the onset of the labor active phase and was repeated every 15 minutes.</i_keyword>
      <i_keyword>Intervention group 2:  The lavender concentration produced by Barij Essen. That was prepared by distillation method with concentration of 1.5% of unopened flowers and olive oil was used as the carrier. In this group, a piece of cloth was impregnated with 0.2 ml of the rose oil and was attached to the collar of the patients and patient inhaled the rose smell. This process starts from the onset of the labor active phase and was repeated every 15 minutes.</i_keyword>
      <i_keyword>Control group: Distilled water.A drop of distilled water was stacked on a piece of cloth and was attached to the patient's collar. The process was repeated every 15 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Labor pain. Timepoint: At the beginning of the  study and at 4-5 cm, 6-7 cm and 8-10 cm dilatation. Method of measurement: McGill Pain Relief Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and after intervention. 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>Zabol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-24</approval_date>
        <contact_name>Ethics committee of Zabol University of Medical Sciences</contact_name>
        <contact_address>No8, Taleghani 47, Taleghani street Zabol Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
