<?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>IRCT20191208045660N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-15</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mindfulness on labor pain in primiparous women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mindfulness on labor pain in primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44076</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Samples will be randomly assigned   to the control and intervention groups using a four-block design using a coin throw.</study_design>
      <phase>3</phase>
      <hc_freetext>Intensity of labor pain in active phase.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: There are 56 pregnant women in this group who will receive routine pregnancy care and childbirth preparation classes + 8 mindfulness training sessions. Intervention 2: Control group: 56 Pregnant women are in this group who will receive routine pregnancy care and childbirth preparation classes.</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:
Part of the data related to the primary and secondary outcomes can be shared.

When:
Start of access period 6 months after printing results

To whom:
Researchers working in academic and scientific institutes and research students in this field.

Conditions:
It is permissible to use results in articles and compare them in new work.

Where to obtain:
E-mail:
z.hasanimotlagh72@yahoo.com 
z.hasanimotlagh@qums.ac.ir
nezalazh@gmail.com

How to obtain:
After the applicant's request by email, the necessary reviews will be made and information will be available shortly after approval.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zeinabhasanimotlagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Boulevard. Qazvin University of Medical Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15315-34199</zip>
        <telephone>(5-33336001) (28)</telephone>
        <email>z.hasanimotlagh72@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zeinab hasani motlagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Boulevard. Qazvin University of Medical Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15315-34199</zip>
        <telephone>(5-33336001) (28)</telephone>
        <email>z.hasanimotlagh72@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- Primiparous Pregnant Women, from Week 20 to 23
Having at least a third-grade guidance degree
Age range 18 to 35 years
Single pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>High-risk pregnancy (based on Integrated Maternal Health Care Booklet)
Experience with meditation and yoga
Known mental illnesses and drug use
Scheduled cesarean birth
- Any need for emergency intervention in the mother and fetus in cases such as bleeding, tandem contractions, accelerated labor, fetal distress, premature placental abruption, cesarean section
Normal contraindications (placenta previa, pelvic stenosis, no fetal rotation)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>000-099</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>pregnancy,childbirth and the pureperium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: There are 56 pregnant women in this group who will receive routine pregnancy care and childbirth preparation classes + 8 mindfulness training sessions.</i_keyword>
      <i_keyword>Control group: 56 Pregnant women are in this group who will receive routine pregnancy care and childbirth preparation classes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of labor pain in two groups. Timepoint: after admission the severity of pain at 4, 6,8,10 and in second stage and when laceration or episiotomy . Method of measurement: In the study of the effect of mindfulness on labor pain, how variable measure can be visual analogue scale and McGill questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Measuring the length of the first, second and third stages of labor. Timepoint: In the study of the effect of mindfulness on labor pain in primiparous women, the timing of measuring the length of the first, second and third stages of labor can be during the active phase of labor and postpartum. Method of measurement: In studying the effect of mindfulness on labor pain in primiparous women, how the secondary variable measuring the length of the first, second and third stages of labor can be measured in minutes and hours.</sec_outcome>
      <sec_outcome>The severity of episiotomy pain. Timepoint: In the study of the effect of mindfulness on labor pain in primiparous women, time periods of measuring the severity of episiotomy pain may be postpartum and undergoing episiotomy repair. Method of measurement: In studying the effect of mindfulness on labor pain in primiparous women, how to measure secondary variable of severity of pain can be McGill questionnaire and visual analogue scale .</sec_outcome>
      <sec_outcome>The amount of analgesia used. Timepoint: In the study of the effect of mindfulness on labor pain in primiparous women, time periods are measured to measure the amount of analgesic drug use throughout the labor stages. Method of measurement: In the study of the effect of mindfulness on labor pain in primiparous women, how to measure the secondary variable of analgesic drug use can be case study and question.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-04</approval_date>
        <contact_name>ethics committee of qazvin university of medical sciences</contact_name>
        <contact_address>Shahid Bahonar Boulevard - Qazvin University of Medical Sciences qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
