<?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>IRCT20221116056514N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-27</date_registration>
      <primary_sponsor>Ilam University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of cognitive counseling based on mindfulness (MBCT) on psychological well-being and choosing the type of delivery in pregnant women who referred to childbirth preparation classes at Ayatollah Taleghani Hospital in Ilam city in 2023</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of cognitive counseling based on mindfulness (MBCT) on psychological well-being and choosing the type of delivery in pregnant women who referred to childbirth preparation classes at Ayatollah Taleghani Hospital in Ilam city in 2023</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66906</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After preparing a general list of clients, using Random Allocation Software for Clinical Trials, people are randomly selected in two groups, Blinding description: In this one-way blind study, one of these groups is blinded to the intervention.
Which of the groups should be blinded depends on the type of study, the sample under study or the disease in question and even the type of intervention used. In this study, the participant group was blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type of delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: MBCT therapy sessions will be held according to Kabat-Zinn et al. protocol (Kabat-Zinn et al., 1992) and pregnancy preparation classes in 8 90-minute sessions (two sessions per week). 1) Description of cognitive therapy intervention sessions Behavior based on mindfulness 1) The first session of cognitive therapy based on the presence of mind, setting a general policy taking into account the aspect of confidentiality and personal life of people, inviting people to introduce themselves to each other, practicing physical examination, homework, discussion and setting weekly meetings. , the distribution of tapes and pamphlets will be. 2) The second session will include training for 14 groups of muscles, including forearms, arms, calf muscles, thighs, stomach, chest, shoulders, neck, lips, eyes, and forehead. 3) The third session Relaxed tone for six groups of muscles, including hands and arms, legs and thighs, stomach and chest, forehead and lips, and relaxed tone homework will be training. Inhaling and exhaling with relaxation and without thinking about anything else and teaching the technique of watching breathing and setting the home task of mindfulness of breathing before sleep will be dedicated. Their movements and search for physical sensations, and the homework assignment will be eating mindfulness. 6) The sixth session, training to pay attention to the mind, positive and negative thoughts, whether the thoughts are pleasant or unpleasant, allowing negative and positive thoughts to enter the mind and It will be as easy as removing them from the mind without judgment and paying deep attention to them. 7) The seventh session will include 40 minutes of sitting meditation, reviewing homework, and practicing observing the connection between activity and creation. 8) The eighth session, past materials. It will be a review and summary. 2) Description of the preparation sessions during pregnancy. The first session: In this session, which is held in the 20th to 23rd week of pregnancy, you will get to know the objectives and principles of the classes and how to conduct the classes. You will also learn about the female reproductive system and the names and functions of some organs that are involved in the process of pregnancy and childbirth, personal hygiene, adapting to the physiological changes during pregnancy. You will get to know the common complaints and how to deal with them and you will get to know the skeletal and stretching exercises, breathing and relaxation and you can do the exercises after the session. The second session: In this session, which is held during the 24th to 27th week of pregnancy, you will learn about nutrition during pregnancy, distribution of the food pyramid, correction of posture, skeletal stretching exercises, breathing and relaxation, and after the session you can Do the exercises. Third meeting: This meeting is held in the 28th to 29th week of pregnancy. In this session, you and your wife will learn about mental health, the role of the spouse, changes in mood during pregnancy and the growth and development of the fetus, how to communicate with the fetus and correct the position of courtship, skeletal stretching exercises, breathing and relaxation, and after the session you will You can do the exercises. Fourth session: This session is held in the 30th to 31st week of pregnancy. warning signs/diagnosis of normal and abnormal pains during pregnancy, bleeding * spotting * headache * fetal movements * discharge * rupture of amniotic sac * swelling of hands and feet * correction of the position during pregnancy * skeletal and muscular exercises * in this session you will have nutrition and You will get to know maintaining a proper diet, how to take supplements, childbirth and pain reduction methods, stretching exercises, breathing and relaxed tone, and after the session you can do the exercises. Fifth session: This session is held at 32-33 weeks of pregnancy. It is possible to plan for childbirth/choose the type of childbirth/various methods of pain reduction and anesthesia in the childbirth process/choose the place of childbirth and the necessary equipment for childbirth/visiting the delivery room of a hospital if possible/correcting the situation during pregnancy/skeletal and muscular exercises / Breathing exercises and calmness of the sixth session: This session is held at 34-35 weeks of pregnancy. Familiarity with the process and symptoms of labor pain / Familiarity with the first, second and third stages of labor and how to take care of yourself in each of the stages of labor / The role of pregnancy hormones in the stages of labor / Adapting to the pain of labor / Showing a video or animation of labor / Correcting the situation in pregnancy / Skeletal and muscular exercises/breathing and relaxation exercises, seventh session: This session is held at the 36th week of pregnancy. Postpartum health and care/postpartum warning signs/postpartum grief and depression/breastfeeding training/postpartum exercises/correction of posture during pregnancy/squatting and muscle exercises/breathing and relaxation exercises Eighth session: This session is held in the 37th week of pregnancy. Baby hygiene with an emphasis on the general characteristics of the baby at birth and during the newborn period / Baby care (how to bathe and change clothes, etc.) / Breastfeeding training / Danger signs for the baby / Showing the video of breastfeeding and baby care / Modification Position in pregnancy/skeletal and muscular exercises/breathing exercises and relaxation. Intervention 2: Control group: Control group: The control group will receive only the usual pregnancy care.</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 "No more information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Alizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti St., Correspondent Blvd., next to Iran Khodro</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931975397</zip>
        <telephone>+98 84 3337 2708</telephone>
        <email>alizadeh.elham2@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Alizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti St., Correspondent Blvd., next to Iran Khodro</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931975397</zip>
        <telephone>+98 84 3337 2708</telephone>
        <email>alizadeh.elham2@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age of the participant is between 20 and 40 years old
The gestational age is more than 20 weeks
Absence of drug addiction in the mother
Not  having abortion symptoms
Absence of high blood pressure or diabetes</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participant withdrawal
Absence or not completing meetings completely</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O82.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delivery by emergency caesarean section</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: MBCT therapy sessions will be held according to Kabat-Zinn et al. protocol (Kabat-Zinn et al., 1992) and pregnancy preparation classes in 8 90-minute sessions (two sessions per week). 1) Description of cognitive therapy intervention sessions Behavior based on mindfulness 1) The first session of cognitive therapy based on the presence of mind, setting a general policy taking into account the aspect of confidentiality and personal life of people, inviting people to introduce themselves to each other, practicing physical examination, homework, discussion and setting weekly meetings. , the distribution of tapes and pamphlets will be. 2) The second session will include training for 14 groups of muscles, including forearms, arms, calf muscles, thighs, stomach, chest, shoulders, neck, lips, eyes, and forehead. 3) The third session Relaxed tone for six groups of muscles, including hands and arms, legs and thighs, stomach and chest, forehead and lips, and relaxed tone homework will be training. Inhaling and exhaling with relaxation and without thinking about anything else and teaching the technique of watching breathing and setting the home task of mindfulness of breathing before sleep will be dedicated. Their movements and search for physical sensations, and the homework assignment will be eating mindfulness. 6) The sixth session, training to pay attention to the mind, positive and negative thoughts, whether the thoughts are pleasant or unpleasant, allowing negative and positive thoughts to enter the mind and It will be as easy as removing them from the mind without judgment and paying deep attention to them. 7) The seventh session will include 40 minutes of sitting meditation, reviewing homework, and practicing observing the connection between activity and creation. 8) The eighth session, past materials. It will be a review and summary. 2) Description of the preparation sessions during pregnancy. The first session: In this session, which is held in the 20th to 23rd week of pregnancy, you will get to know the objectives and principles of the classes and how to conduct the classes. You will also learn about the female reproductive system and the names and functions of some organs that are involved in the process of pregnancy and childbirth, personal hygiene, adapting to the physiological changes during pregnancy. You will get to know the common complaints and how to deal with them and you will get to know the skeletal and stretching exercises, breathing and relaxation and you can do the exercises after the session. The second session: In this session, which is held during the 24th to 27th week of pregnancy, you will learn about nutrition during pregnancy, distribution of the food pyramid, correction of posture, skeletal stretching exercises, breathing and relaxation, and after the session you can Do the exercises. Third meeting: This meeting is held in the 28th to 29th week of pregnancy. In this session, you and your wife will learn about mental health, the role of the spouse, changes in mood during pregnancy and the growth and development of the fetus, how to communicate with the fetus and correct the position of courtship, skeletal stretching exercises, breathing and relaxation, and after the session you will You can do the exercises. Fourth session: This session is held in the 30th to 31st week of pregnancy. warning signs/diagnosis of normal and abnormal pains during pregnancy, bleeding * spotting * headache * fetal movements * discharge * rupture of amniotic sac * swelling of hands and feet * correction of the position during pregnancy * skeletal and muscular exercises * in this session you will have nutrition and You will get to know maintaining a proper diet, how to take supplements, childbirth and pain reduction methods, stretching exercises, breathing and relaxed tone, and after the session you can do the exercises. Fifth session: This session is held at 32-33 weeks of pregnancy. It is possible to plan for childbirth/choose the type of childbirth/various methods of pain reduction and anesthesia in the childbirth process/choose the place of childbirth and the necessary equipment for childbirth/visiting the delivery room of a hospital if possible/correcting the situation during pregnancy/skeletal and muscular exercises / Breathing exercises and calmness of the sixth session: This session is held at 34-35 weeks of pregnancy. Familiarity with the process and symptoms of labor pain / Familiarity with the first, second and third stages of labor and how to take care of yourself in each of the stages of labor / The role of pregnancy hormones in the stages of labor / Adapting to the pain of labor / Showing a video or animation of labor / Correcting the situation in pregnancy / Skeletal and muscular exercises/breathing and relaxation exercises, seventh session: This session is held at the 36th week of pregnancy. Postpartum health and care/postpartum warning signs/postpartum grief and depression/breastfeeding training/postpartum exercises/correction of posture during pregnancy/squatting and muscle exercises/breathing and relaxation exercises Eighth session: This session is held in the 37th week of pregnancy. Baby hygiene with an emphasis on the general characteristics of the baby at birth and during the newborn period / Baby care (how to bathe and change clothes, etc.) / Breastfeeding training / Danger signs for the baby / Showing the video of breastfeeding and baby care / Modification Position in pregnancy/skeletal and muscular exercises/breathing exercises and relaxation</i_keyword>
      <i_keyword>Control group: Control group: The control group will receive only the usual pregnancy care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological well-being. Timepoint: Examination of psychological well-being before the intervention, 4 weeks of training (intervention), 2 weeks later re-examination. Method of measurement: After the completion of the meetings and compliance with the criteria for exiting the research during the entire process of holding the meetings, in the last stage of the research questionnaires will be distributed between both experimental and control groups and the data will be collected and analyzed in SPSS software and the results will be obtained. They will be registered.</prim_outcome>
      <prim_outcome>Choice of delivery type. Timepoint: 8 sessions and each session is 90 minutes (twice a week). Method of measurement: After the completion of the meetings and compliance with the criteria for exiting the research during the entire process of holding the meetings, in the last stage of the research questionnaires will be distributed between both experimental and control groups and the data will be collected and analyzed in SPSS software and the results will be obtained. They will be registered.</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>Ilam University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-25</approval_date>
        <contact_name>Ethics Committee of Ilam University of Medical Sciences</contact_name>
        <contact_address>Beheshti Street, Correspondent Boulevard, next to Iran Khodro Ilam Ilam Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
