<?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>IRCT20260205068764N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-25</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of massage with Elaeagnus angustifolia oil and massage with lavender oil on anxiety and labor pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of massage with Elaeagnus angustifolia oil and massage with lavender oil on anxiety and labor pain in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90251</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method is as follows: first, six possible blocks (BAAB, ABBA, BABA, BBAA, ABAB, AABB) are listed, and each block is assigned a number from 1 to 6. Then, using a random number table in Excel, a number between 1 and 6 is randomly selected, and participants are allocated to groups according to the block corresponding to that number. This process is repeated until the total sample size is reached. Allocation concealment is performed by an individual, and to conceal the allocation method, the blocks are placed in sealed envelopes.
Furthermore, to ensure homogeneity between the two groups regarding the number of primiparous women, participants are stratified based on their current delivery status (first delivery, etc.). The block randomization method is then implemented within each stratum.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Anxiety. Condition 2: Labor pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention groupMassage with 10 drops of oleaster oil from Giahe Kala Company, which has the Sib-e Salamat (health mark) and necessary health permits, is 100% pure and organic, free from additives and preservatives, packaged in antibacterial containers with a volume of 30 cc. The massage will be performed using effleurage (gentle rubbing) with moderate pressure. Simultaneously with the onset of contractions, the mother will be placed in a side-lying position, and a full-back massage will be given for 20 minutes during three stages of cervical dilation: 3–4 cm, 5–7 cm, and 8–10 cm. Intervention 2: Control group:Massage with 10 drops of lavender oil from Giahe Kala Company, which has the Sib-e Salamat (health mark) and necessary health permits, is 100% pure and organic, free from additives and preservatives, packaged in antibacterial containers with a volume of 30 cc. The massage will be performed using effleurage (gentle rubbing) with moderate pressure. Simultaneously with the onset of contractions, the mother will be placed in a side-lying position, and a full-back massage will be given for 20 minutes during three stages of cervical dilation: 3–4 cm, 5–7 cm, and 8–10 cm.</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 DONT KNOW</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Simin Ashrafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 32, Second Floor, Second Door on the Left, Emam Reza 26, Jomhouri 40</address>
        <city>Kashmar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9671975820</zip>
        <telephone>+98 51 5523 7271</telephone>
        <email>ashrafisimin5@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Simin Ashrafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 32, Second Floor, Second Door on the Left, Emam Reza 26, Jomhouri 40</address>
        <city>Kashmar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9671975820</zip>
        <telephone>+98 51 5523 7271</telephone>
        <email>ashrafisimin5@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A healthy, alive, single fetus with no anomalies
The mother has no pregnancy-related or medical complications such as preeclampsia, diabetes, active bleeding, or severe cardiac disorders that would prevent massage or continuation of natural labor
The delivery is the first to the third
The estimated fetal weight according to the most recent ultrasound is 2500 to 4000 grams
The fetal lie is longitudinal and the presenting part is cephalic
The gestational age is between 37 and 41 weeks
Body mass index at delivery is between 18.5 and 29.9
Regular uterine contractions three times in ten minutes
Cervical dilation of at least 3-4 centimeters
Informed consent to participate in the research</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of allergy to oleaster (Elaeagnus angustifolia) and lavender
Skin infection or lesion in the massage area
History of infertility or use of assisted reproductive technique
Occurrence of a stressful event in the past 6 months (such as divorce, death of first-degree relatives of the mother
Psychiatric disorder based on maternal self-report
Maternal addiction by maternal self-report
Having an accompanying midwife or doula
Any maternal disability (blindness, deafness, hearing loss, motor impairment
Use of other non-pharmacological methods for reducing labor pain
Use of herbal medications during or before delivery
History of pregnancy or delivery complications (neonatal death, dystocia, stillbirth</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention groupMassage with 10 drops of oleaster oil from Giahe Kala Company, which has the Sib-e Salamat (health mark) and necessary health permits, is 100% pure and organic, free from additives and preservatives, packaged in antibacterial containers with a volume of 30 cc. The massage will be performed using effleurage (gentle rubbing) with moderate pressure. Simultaneously with the onset of contractions, the mother will be placed in a side-lying position, and a full-back massage will be given for 20 minutes during three stages of cervical dilation: 3–4 cm, 5–7 cm, and 8–10 cm</i_keyword>
      <i_keyword>Control group:Massage with 10 drops of lavender oil from Giahe Kala Company, which has the Sib-e Salamat (health mark) and necessary health permits, is 100% pure and organic, free from additives and preservatives, packaged in antibacterial containers with a volume of 30 cc. The massage will be performed using effleurage (gentle rubbing) with moderate pressure. Simultaneously with the onset of contractions, the mother will be placed in a side-lying position, and a full-back massage will be given for 20 minutes during three stages of cervical dilation: 3–4 cm, 5–7 cm, and 8–10 cm</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Labor pain intensity. Timepoint: before the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Labor pain intensity. Timepoint: after the intervention at dilation of 3–4 cm. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Labor pain intensity. Timepoint: after the intervention at dilation of 5-7cm. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Labor pain intensity. Timepoint: after the intervention at dilation of 8-10cm. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Anxiety intensity. Timepoint: Before the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Anxiety intensity. Timepoint: after the intervention at dilation of 3–4 cm. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Anxiety intensity. Timepoint: after the intervention at dilation of 5-7 cm. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Anxiety intensity. Timepoint: after the intervention at dilation of 8-10 cm. 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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-05-15</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Gonabad, side of Asian Road Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
