<?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>IRCT20171007036615N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-16</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mindfulness-based counseling on nulliparous women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mindfulness-based counseling on childbirth experience and support and control among nullipar women: a randomised controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61030</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants using the RAS(Random Allocation Software)with the size of 4 and 6 blocks and quotas based on the type of labor pain onset (spontaneous or induction) and with a ratio of 1: 1 to the two groups receiving mindfulness counseling and allocation control group Will be given. Blocking was performed by a person not involved in sampling and data analysis. For concealment, the intervention type assignment will be written on a piece of paper and placed in matte envelopes and numbered in a row. These envelopes will be opened in the presence of the mother and by a person not involved in sampling (in charge of the hospital clinic) and the type of group will be informed to the mother.</study_design>
      <phase>N/A</phase>
      <hc_freetext>childbirth experience and support and control.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pregnant mothers who are in the mindfulness group, for 8 sessions of counseling program with the content of mindfulness as walking: walking slowly and intentionally and paying attention to movements, weight changes and balance and sensations in the legs that are related to walking. The process of eating: continues by feeling the raisins in the mouth, biting them, paying attention to the taste and texture, and the sensations and movements of the mouth and throat while chewing and swallowing the raisins. Awareness is done. Body scan: When lying on your back for 40 minutes, your attention is directed to different parts of your body (from toes to head) and you pay attention to the emotions in every part of your body with openness and curiosity.Sitting meditation: In a sitting position, the person is asked to pay attention to the feelings and movements of breathing. The person is instructed to pay attention to bodily feelings without judgment and acceptance. Yoga: Slow and gradual yoga Hatha Consciously nurtures the body when moving, stretching or maintaining a posture. Enters the body slowly and deeply into a dome-shaped body and abdomen, and then exhale very slowly without any pressure or contraction. It will be a minute.The assignments requested from the mothers in cyberspace will be reviewed by the researcher and the mother will be given feedback. Finally, after hospitalization and stabilization in the delivery room for each of the women in the mindfulness group, she will be reminded of the trainings of mindfulness techniques and in order to perform the steps of mindfulness correctly during labor and dilation of six centimeters ( Active phase of labor) will guide. Intervention 2: Control group:. For the control group of routine care training (Trainings based on the educational content of physiological delivery, including nutritional, health, exercise and information's about  physiological delivery and pain relief delivery methods) in pregnancy will be held as a session every week online and in person.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Esmat Mehrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>b.mehrabi@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Esmat Mehrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>b.mehrabi@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The first delivery
Live cephalic single fetus
Tendency to give birth in Al-Zahra and Taleghani hospitals
Lack of mental disability and deafness</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1. History of pre-pregnancy mental disorders according to the patient3. 4. 5. 6. 7. 8. 9. 10.
Abnormal volume of amniotic fluid
NST non-reactive
Fetal malformations
Have any surgery on the uterus
Having high-risk pregnancies such as hypertension, diabetes, placenta previa, cardiovascular disease and other chronic diseases, bleeding in the third trimester, placental abruption, placenta previa, fetal growth disorder
Pregnancy with the help of assisted reproductive techniques
The desire to receive other pharmacological and non-pharmacological analgesics
Unplanned pregnancy
Any contraindications for vaginal delivery, including pelvic series mismatch</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>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pregnant mothers who are in the mindfulness group, for 8 sessions of counseling program with the content of mindfulness as walking: walking slowly and intentionally and paying attention to movements, weight changes and balance and sensations in the legs that are related to walking. The process of eating: continues by feeling the raisins in the mouth, biting them, paying attention to the taste and texture, and the sensations and movements of the mouth and throat while chewing and swallowing the raisins. Awareness is done. Body scan: When lying on your back for 40 minutes, your attention is directed to different parts of your body (from toes to head) and you pay attention to the emotions in every part of your body with openness and curiosity.Sitting meditation: In a sitting position, the person is asked to pay attention to the feelings and movements of breathing. The person is instructed to pay attention to bodily feelings without judgment and acceptance. Yoga: Slow and gradual yoga Hatha Consciously nurtures the body when moving, stretching or maintaining a posture. Enters the body slowly and deeply into a dome-shaped body and abdomen, and then exhale very slowly without any pressure or contraction. It will be a minute.The assignments requested from the mothers in cyberspace will be reviewed by the researcher and the mother will be given feedback. Finally, after hospitalization and stabilization in the delivery room for each of the women in the mindfulness group, she will be reminded of the trainings of mindfulness techniques and in order to perform the steps of mindfulness correctly during labor and dilation of six centimeters ( Active phase of labor) will guide.</i_keyword>
      <i_keyword>Control group:. For the control group of routine care training (Trainings based on the educational content of physiological delivery, including nutritional, health, exercise and information's about  physiological delivery and pain relief delivery methods) in pregnancy will be held as a session every week online and in person.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Childbirth experience score. Timepoint: 24 hours after delivery. Method of measurement: Denker Childbirth Experience Questionnaire.</prim_outcome>
      <prim_outcome>Support and control score. Timepoint: Before intervention and 24 hours after delivery. Method of measurement: Support and control questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain perception score. Timepoint: Dilatation at 6 cm and 24 hours after delivery. Method of measurement: Childbirth pain questionnaire Visual Analog Scale.</sec_outcome>
      <sec_outcome>Fear of childbirth score. Timepoint: Dilatation at 6 cm and 24 hours after delivery. Method of measurement: Fear of childbirth in the labor stage will be using the WDE-Q (A) questionnaire and in the postpartum stage with the WDE-Q (B) fear of childbirth questionnaire.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-06</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz college of Nursing and Midwifery, South Shariati St., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
