<?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>IRCT20190322043098N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-27</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of Solvia oil in two methods of Massage and Aromatherapy on intensity of  labor pain in primiparous women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Solvia oil in two methods of Massage and Aromatherapy on intensity of  labor pain in primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38514</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: ---Examples of each group for the statistical counselor will be unknown.</study_design>
      <phase>N/A</phase>
      <hc_freetext>-.</hc_freetext>
      <i_freetext>Intervention 1: 1. Group A: Group A (aromatherapy with solvia oil) In this study, women have a sensation of 5-4, 7-6, and 10-8 cm dilatations. The herbal scent is smeared with 10% bean oil for 20 minutes, and the severity of pain after 20 Minutes are recorded. Intervention 2: Group B: Group B (Massage Therapy with solvia oil) In this study, women who have been treated with an extract of essential oil in a 4x4, 7-6, and 10-8cm dilates for 20 minutes, 10 percent made by Healing Kurdistan Corporation. And the severity of pain is recorded after 20 minutes. Intervention 3: Control group: In the study, the group C (control) in this study is women who have routine care in dilates 5-4, 7-6 and 10-8.</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:
Information on the effect of the herbal extracts on the severity of labor pain will be released.primiparous women admitted to the delivery ward of Beasat Hospital in Sanandaj  in 2019.

When:
-Start the access period 6 months after printing the results

To whom:
-Researchers working in academic institutions and pharmaceutical companies

Conditions:
-No institution and anyone else has access.

Where to obtain:
bahareh noori monfared
nouri.b1365@gmail.com
09189294236

How to obtain:
-After accessing the data and verifying the request by the researcher and the research executor, data is provided to individuals or institutions within at least three months.

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bahareh Noori Monfared</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Boulevard, Kurdistan University of Medical Sciences</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617715175</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>Nouri.b1365@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Zaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Boulevard, Kurdistan University of Medical Sciences</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617715175</zip>
        <telephone>+98 87 3366 4653</telephone>
        <email>f.zaheri1968@gmail.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The desire to participate in the study
Women aged 40-18
Pregnancy age between 42-37 weeks
4-3 cm dilatation
At least reading and writing skills
Having a natural garden before studying
Not having a midwife along
Exposure to the embryo
Not having diseases like cancer, lumbar disc disease, high blood pressure, seizures, diabetes, high fever, infectious disease,</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Rupture more than 6 hours a bottle of water
Get anorexia three hours before the study begins
Multiplayer women
Known mental illness
Surgery of the spine in the last three months
The occurrence of any stressful event involving the separation of the spouse, the death of the loved ones within the past six months
Drug Addiction and Psychosocial
History of sensation and allergy to fragrances
Third-trimester bleeding
Abortion history</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1. Group A: Group A (aromatherapy with solvia oil) In this study, women have a sensation of 5-4, 7-6, and 10-8 cm dilatations. The herbal scent is smeared with 10% bean oil for 20 minutes, and the severity of pain after 20 Minutes are recorded.</i_keyword>
      <i_keyword>Group B: Group B (Massage Therapy with solvia oil) In this study, women who have been treated with an extract of essential oil in a 4x4, 7-6, and 10-8cm dilates for 20 minutes, 10 percent made by Healing Kurdistan Corporation. And the severity of pain is recorded after 20 minutes.</i_keyword>
      <i_keyword>Control group: In the study, the group C (control) in this study is women who have routine care in dilates 5-4, 7-6 and 10-8</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of labor pain is measured based on a pain reliever. Timepoint: -In dilates of 5-4, 7-6 and 8-10 cm cervix before and after intervention in the studied groups. Method of measurement: Based on the visual scale of the pain, which is a 10-cm ruler, the zero number on the left indicates no pain and the number 10 on the right.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-19</approval_date>
        <contact_name>Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Kurdistan University of Medical Sciences Pasdaran Blvd, Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
