<?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>IRCT20130718014049N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-12</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aromatherapy in women undergoing cesarean section with spinal anesthesia on neonatal apgar score</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effect of Aromatherapy on Pregnant mothers with Flavors of Citrus aurantium on the Apgar score of newborn infants during elective cesarean section surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45075</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: To randomize the subjects, the dice will be divided into two groups: intervention and control.In this way, once a dice is thrown for each patient, the patient with will be in the even number will be in intervention group, and patient with odd number will be in the control group.In addition the person evaluating the consequence is unaware of the manner and results of this accident, Blinding description: A double blind method was used for blinding in this study so that 1- volunteer 2- Neonatal Apgar Scale Measurer does not know about intervention and control groups.Both intervention and control groups will be told that drops of liquid will be poured onto the cotton and you will be asked to breathe in with normal breathing;So they won't know the type of drop.Due to the fact that the patient of the intervention group did not know the type of substance used in the patient, the control group (distilled water) and while our dependent variable is measured from the newborn؛Therefore, the mother and baby do not know their intervention group؛So if the mother's condition affects the dependent variable, which is measured from the baby, the mother still has no knowledge of her intervention or control group.،Because it does not know the type of material used in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Apgar score scale after maternal aromatherapy.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Half an hour before entering the operating room, 3 drops of distilled water are poured on a cotton pad and we ask the person to breathe for 10 minutes from a distance of 10 cm (cotton soaked in distilled water). It is attached to the collar of the patient's operating room collar (10 cm from the nose) and will continue until the operating room arrives. Then after the baby is born, Weight and apgar score will be recorded  at one and five minutes after birth by a pre-trained researcher who has no knowledge of whether the patient and her infant are in the intervention or control group. Intervention 2: Intervention group: Half an hour before entering the operating room, the aromatherapy mixture containing 3 drops of 10%  Citrus aurantium , prepared by Tebab Drug Company, is poured onto a cotton pad and the person is asked to rest for 30 minutes on a regular basis. Breathe in with a normal breath of 10 cm (the essential oil cotton is attached to the collar of patients' operating room 10 cm from the nose) and this process will continue until entering the operating room. Then after the baby is born, Weight and apgar score will be recorded  at one and five minutes after birth by a pre-trained researcher who has no knowledge of whether the patient and her infant are in the intervention or control group.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Abasi Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research deputy, Jahrom University of Medical science, martyr Motaharie Blvd, Jahrom</address>
        <city>jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>+98 71 5434 0406</telephone>
        <email>aliabbasijahromi@yahoo.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Abasi Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research deputy, Jahrom University of medical science, martyr Motaharie Blvd, Jahrom</address>
        <city>jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>+98 71 5434 0406</telephone>
        <email>aliabbasijahromi@yahoo.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients undergoing cesarean section at Motahari Hospital of Jahrom University of Medical Sciences.
Spinal anesthesia for the mother has been approved by the anesthesiologist.
Term pregnancy
Patient Satisfaction to Participate in the Study and No Sensitivity to Citrus aurantium
Term pregnancy
Non-emergency surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Respiratory Disease
Pain medication for the past 8 hours
Incidence of labor complications such as vaginal bleeding during research
Addiction and psychotropic drugs
The patient and his wife declare their consent to continue 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>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Half an hour before entering the operating room, 3 drops of distilled water are poured on a cotton pad and we ask the person to breathe for 10 minutes from a distance of 10 cm (cotton soaked in distilled water). It is attached to the collar of the patient's operating room collar (10 cm from the nose) and will continue until the operating room arrives. Then after the baby is born, Weight and apgar score will be recorded  at one and five minutes after birth by a pre-trained researcher who has no knowledge of whether the patient and her infant are in the intervention or control group.</i_keyword>
      <i_keyword>Intervention group: Half an hour before entering the operating room, the aromatherapy mixture containing 3 drops of 10%  Citrus aurantium , prepared by Tebab Drug Company, is poured onto a cotton pad and the person is asked to rest for 30 minutes on a regular basis. Breathe in with a normal breath of 10 cm (the essential oil cotton is attached to the collar of patients' operating room 10 cm from the nose) and this process will continue until entering the operating room. Then after the baby is born, Weight and apgar score will be recorded  at one and five minutes after birth by a pre-trained researcher who has no knowledge of whether the patient and her infant are in the intervention or control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Apgar score. Timepoint: The first minute after birth. Method of measurement: Based on Apgar Scale.</prim_outcome>
      <prim_outcome>Apgar score. Timepoint: Fifth minute after birth. Method of measurement: Based on Apgar 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>En Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-25</approval_date>
        <contact_name>Ethic Committee of Jahrom University of Medical Sciences</contact_name>
        <contact_address>Ethic committee, Jahrom University of medical science, martyr Motaharie Blvd, Jahrom Jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
