<?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>IRCT20260514069397N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-02</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Citrus aurantium Aroma on Anxiety and Duration of Labor Stages in Nulliparous Women</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Citrus aurantium Aroma on Anxiety and Duration of Labor Stages in Nulliparous Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/90175</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants enrolled in the study will be allocated to study groups using the permuted block method. Block sizes of 4 and 6 will be considered. Randomization will be performed using the blockrand package in R software.</study_design>
      <phase>3</phase>
      <hc_freetext>Anxiety and the duration of labor stages.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: . In the intervention group, 4 drops of spring orange essential oil are added to 300 ml of water and in the control group, 4 drops of normal saline are added to 300 ml of water and are continuously diffused through an aroma diffuser throughout the entire labor process. Anxiety intensity will be measured 30 minutes after aromatherapy at 3-4 and 6-8 cm dilations. The duration of labor will be measured from 3-4 cm dilation to 10 cm, from 10 cm dilation to delivery of the baby, and from delivery of the baby to delivery of the placenta in both groups. Intervention 2: Control group: In the control group, 4 drops of normal saline are poured into 300 ml of water and continuously diffused through an aroma diffuser throughout the entire duration of labor, and the intensity of anxiety will be measured 30 minutes after aromatherapy at dilations of 3-4 and 6-8 cm. The duration of labor will be measured from dilation of 3-4 cm to 10 cm, from dilation of 10 cm to delivery of the baby, and from delivery of the baby to delivery of the placenta in both groups.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soheila Pirdade Beyranvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kamalvand</address>
        <city>Khoramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6813833946</zip>
        <telephone>+98 66 0333 3302</telephone>
        <email>kimia_n72@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheila Pirdadeh Beyranvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kamalvand</address>
        <city>Khoramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6813833946</zip>
        <telephone>+98 66 3330 2033</telephone>
        <email>kimia_n72@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian ethnicity
Primiparous
Singleton pregnancy with a gestational age of 37 to 42 weeks
Maternal age between 18 and 35 years
Cervical dilation of 3–4 cm
At least 2 to 3 spontaneous uterine contractions lasting 40–45 seconds within 10 minutes
Regular fetal heart rate between 110 and 160 beats per minute
Normal maternal vital signs
Normal fetal movements according to the mother’s report
Body mass index of 18.5–29.9 kg/m²
Height greater than 145 cm
Estimated fetal weight between 2500 and 4000 g
Compatibility of the fetal head with the maternal pelvis
Consistency of fundal height with gestational age
Cephalic fetal presentation
Intact amniotic sac</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Presence of medical and obstetric complications in the current pregnancy
Use of anti-anxiety medications and supplements
Fetal distress or disorder in labor progression
Development of sensitivity to orange blossom essential oil
Presence of olfactory disorders, allergies, or previous unpleasant experiences with specific scents
Use of analgesic or anti-anxiety medication at least 3 hours before the start of the intervention
Addiction to tobacco, narcotics, or alcoholic beverages
Presence of any contraindication to vaginal delivery
Need for labor augmentation with oxytocin or other methods
Need for emergency cesarean section
Need to use other pharmacological or non-pharmacological pain relief methods
Experiencing a major adverse event during the past 3 months</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>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: . In the intervention group, 4 drops of spring orange essential oil are added to 300 ml of water and in the control group, 4 drops of normal saline are added to 300 ml of water and are continuously diffused through an aroma diffuser throughout the entire labor process. Anxiety intensity will be measured 30 minutes after aromatherapy at 3-4 and 6-8 cm dilations. The duration of labor will be measured from 3-4 cm dilation to 10 cm, from 10 cm dilation to delivery of the baby, and from delivery of the baby to delivery of the placenta in both groups.</i_keyword>
      <i_keyword>Control group: In the control group, 4 drops of normal saline are poured into 300 ml of water and continuously diffused through an aroma diffuser throughout the entire duration of labor, and the intensity of anxiety will be measured 30 minutes after aromatherapy at dilations of 3-4 and 6-8 cm. The duration of labor will be measured from dilation of 3-4 cm to 10 cm, from dilation of 10 cm to delivery of the baby, and from delivery of the baby to delivery of the placenta in both groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of anxiety during the first stage of labor. Timepoint: Before aromatherapy and twice after the intervention at dilations of 3 to 4 and 6 to 8 cm. Method of measurement: Spielberger Anxiety Assessment Questionnaire.</prim_outcome>
      <prim_outcome>Labor time. Timepoint: Every one to two hours. Method of measurement: Examination and registration in the examination form.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-05-12</approval_date>
        <contact_name>“Ethics Committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Moallem St., Anoushirvan Rezaei Square, Lorestan University of Medical Sciences Headquarters khoramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
