<?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>IRCT20200810048357N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-05</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of reflexology  on reducing labor pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of foot trigger reflexology with aromatherapy on anxiety, pain and consequences of  labor  pregnancy in women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50265</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each mother was allocated randomly to one of the intervention or control groups. The random sampling was performed by  drawing 105 cards labeled as intervention1,intervention 2 and control equally from a matte box .Thus the random sequence was not predictable.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Labor pain.</hc_freetext>
      <i_freetext>Intervention 1: intervention group 1 : Routine cares along with reflexology technique of trigger  points of sole with non-aromatic oil (olive oil)was continued for a period of 20 minutes for each foot. Reflexology with olive oil was taken place at one time in 4-5 cm dilatation. Intervention 2: Intervention group2:  Routine cares along with Reflexology technique of trigger points of Sole with aromatic oil (Lavender oil)was continued for a period of 20 minutes for each foot. Reflexology with Lavender oil was taken place at one time in 4-5 cm dilatation. Intervention 3: Control group: routine maternity cares (control of contractions, fetal heart rate, monitoring labor progress, and no sedative drug interventions) performed Throughout the labor.</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:
Only part of the data that is related to the main outcome and is electronic will be available via e-mail after authentication and eligibility of the applicants.

When:
One year after the publication of the article  and for one year the data will become available.

To whom:
Researchers and academics in universities

Conditions:
Only systematic review and meta-analysis of data will be possible

Where to obtain:
Call the number 0098 9367088289. Farahi farzaneh

How to obtain:
Having sufficient explanations and clarify their purpose for data analysis. additionaly presenting a formal request from a research institute or university.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Farahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>14 Alley , Shareefabad Ave</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7157874696</zip>
        <telephone>+98 71 3720 5444</telephone>
        <email>frznfarahi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Farahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alley 14 , Shareefabad Ave</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7157874696</zip>
        <telephone>+98 71 3720 5444</telephone>
        <email>frznfarahi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>primigravida mothers having single term pregnancy with cephalic presentation
The least dilatation of 4-5cm (the beginning of active phase of delivery
No medical problems or pregnancy and fetal complications
Without applying Analgesics and Anesthetics,
Possessing psychical and cognitive ability to cooperate
Having informed consent for participation</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Miscarriage history
High risk pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O75.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified complications of labor and delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group 1 : Routine cares along with reflexology technique of trigger  points of sole with non-aromatic oil (olive oil)was continued for a period of 20 minutes for each foot. Reflexology with olive oil was taken place at one time in 4-5 cm dilatation</i_keyword>
      <i_keyword>Intervention group2:  Routine cares along with Reflexology technique of trigger points of Sole with aromatic oil (Lavender oil)was continued for a period of 20 minutes for each foot. Reflexology with Lavender oil was taken place at one time in 4-5 cm dilatation</i_keyword>
      <i_keyword>Control group: routine maternity cares (control of contractions, fetal heart rate, monitoring labor progress, and no sedative drug interventions) performed Throughout the labor.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Labor pain. Timepoint: Pain  were measured before intervention and then after intervention in 4- 5 and 7- 8 cm dilatation. Method of measurement: Visual analogue  scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Anxiety was measured before intervention and then after intervention in 4-5 and 7-8 cm dilation. Method of measurement: Spielberger questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Apgar score. Timepoint: Immediately after birth. Method of measurement: Using the Apgar score table.</sec_outcome>
      <sec_outcome>Duration of the first stage of labor. Timepoint: Measure the  time between dilatations 4-10 cm. Method of measurement: Time measurement.</sec_outcome>
      <sec_outcome>Duration of the second stage of labor. Timepoint: From dilatation 10 cm to delivery. Method of measurement: Time measurement.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-16</approval_date>
        <contact_name>Ethics committee  of Kazeroon Islamic Azad University</contact_name>
        <contact_address>Shahid Ghasem soleimani Blvd., Kazeroon azad university Kazeroon Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
