<?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>IRCT20171007036615N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-16</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mindfulness techniques in counseling with and without acupressure on pain and childbirth experience in primiparous women: a randomized controlled clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mindfulness techniques in counseling with and without acupressure on pain and childbirth experience in primiparous women: a randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74561</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: Using Random Allocation Software, RAS, the participants will be assigned to three groups receiving mindfulness counseling without acupressure, mindfulness counseling with acupressure, and the control group with a block size of 9 and with an allocation ratio of 1:1:1. became. Blocking will be done by a person not involved in data sampling and analysis (responsible for the clinic). In order to hide the allocation, the type of intervention will be written on a sheet of paper and placed inside opaque envelopes numbered consecutively. These envelopes will be opened in the presence of the mother and the type of group will be informed to the mother, Blinding description: Due to the nature of the study, this study is single blind.In this way, the person analyzing the data will not be aware of the type of intervention groups.
​.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pain of child birth.</hc_freetext>
      <i_freetext>The first intervention group: pregnant mothers who are in this group will receive 8 counseling sessions with mindfulness content, including two sessions per week in person (in groups of 4-6 people), each session lasting 45 minutes. The second intervention group: They will receive 8 counseling sessions with mindfulness content, including two sessions per week in person (in groups of 4-6 people), each session lasting 45 minutes. For the intervention group receiving mindfulness with acupressure stimulation of pressure points (KD1 (Kidney 1), SPECIAL HAND-COMB TECHNIQUE) will be taught. In case the mother is unable to participate in the counseling sessions for 1-2 sessions, further training will be provided with telephone and virtual follow-ups. Finally, after the delivery bed and stabilization of the situation in the delivery room, for each of the women in the mindfulness group, mindfulness techniques training Awareness will be reminded. The control group will receive routine pregnancy care training..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is "There is no further information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Esmat Mehrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Shariati St</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>b.mehrabi62@gmail.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 St</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>b.mehrabi62@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with first pregnancy
Age 18-45 years
Living in Tabriz city
Gestational age 32-34 weeks at the time of study entry
Willingness to give birth in Al-Zahra and Taleghani centers and 29 Bahman Social Security Hospital in Tabriz</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Prior knowledge of yoga
Multiple pregnancy
Suffering from chronic diseases or induced or aggravated during pregnancy, such as hypertension, cardiovascular diseases, diabetes, preeclampsia, etc.
Cesarean indications such as placenta previa, non-cephalic presentations, abnormal fetal heartbeats and...
Known indication for caesarean section or hysterectomy
Hospitalization after 6 cm dilatation
Abnormal pregnancy process such as polyhydramnios, oligohydramnios, intrauterine growth disorder
Pregnancy with assisted reproduction methods</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: pregnant mothers who are in this group will receive 8 counseling sessions with mindfulness content, including two sessions per week in person (in groups of 4-6 people), each session lasting 45 minutes. The second intervention group: They will receive 8 counseling sessions with mindfulness content, including two sessions per week in person (in groups of 4-6 people), each session lasting 45 minutes. For the intervention group receiving mindfulness with acupressure stimulation of pressure points (KD1 (Kidney 1), SPECIAL HAND-COMB TECHNIQUE) will be taught. In case the mother is unable to participate in the counseling sessions for 1-2 sessions, further training will be provided with telephone and virtual follow-ups. Finally, after the delivery bed and stabilization of the situation in the delivery room, for each of the women in the mindfulness group, mindfulness techniques training Awareness will be reminded. The control group will receive routine pregnancy care training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Understanding labor pain score. Timepoint: 24 hours after delivery. Method of measurement: Childbirth Pain Perception Questionnaire.</prim_outcome>
      <prim_outcome>Birth experience score. Timepoint: 24 hours after delivery. Method of measurement: Denker childbirth experience questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The score of support and control in birth. Timepoint: 24 hours after delivery. Method of measurement: Support and Control in birth questionnaire.</sec_outcome>
      <sec_outcome>Length of labor stages score. Timepoint: 24 hours after delivery. Method of measurement: Viewing/checking partograph and midwifery profile section.</sec_outcome>
      <sec_outcome>Cesarean frequency score. Timepoint: 24 hours after delivery. Method of measurement: View/check the midwifery profile section.</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>2024-01-01</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University, University Koi, Vice-Chancellor of Technology Research, Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
