<?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>IRCT20190204042622N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-08</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The effect of couple counseling with cognitive-behavioral approach on severe labor pain and postpartum blues and depression</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of couples counseling with cognitive-behavioral approach on the severity of labor pain and prevention of postpartum blues and depression in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>116</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56373</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Quadruple blocks. In this study, we will use the Restricted randomization method of block randomization. The size of all blocks is equal and we in this two-group experiment of 4 blocks (including 2 participants in We will have an intervention group and 2 participants in the control group). The method of hiding the sequence of allocating white envelopes is used. Using the website https://www.sealedenvelope.com/simple-randomiser/v1/lists and with the help of the methodology consultant, the allocation sequence was generated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postpartum blues and depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to attending childbirth preparation classes, intervention groups also attend cognitive-behavioral counseling sessions with their spouse. The Cognitive Behavioral Counseling Group will participate in 4 1-hour sessions. Due to the increase in the sample size, each group of people are placed in groups of 8 to 12 people for counseling.At the beginning of counseling classes, the informed consent form is completed in writing and the demographic profile form and the design questionnaire including grief and depression are completed.                                                                                                                          A Brief Description of Cognitive-Behavioral Couple Sessions in Research (Cognitive Therapy Techniques by Robert Lee Hee):Session 1: Establishing a good relationship and getting acquainted with the principles and goals of cognitive-behavioral couple therapy, examining and recognizing the goals of members participating in the sessions. Session 2: Identifying unrealistic beliefs and expectations of couples by providing cognitive skills Session 3: Correcting mistakes Cognitive (thinking all or nothing, exaggerated generalization, subjective filtering, neglect of the positive, hasty conclusions, mind reading, prediction, magnification, emotional reasoning, do's and don'ts, labeling, personalization and blame.), Clearing up misunderstandings Due to misconceptions or differences from each other - Replacing realistic beliefs and expectations (cognitive skills) Session 4: Teaching effective communication skills between couples (verbal and non-verbal communication, empathetic understanding and active listening) Recognizing patterns of reinforcement and punishment of each Spouses, Increasing Positive Reinforcers and Increasing Positive Behavioral Exchanges (Behavioral Skills). Homework: We teach couples in any intense and annoying emotional situation they have experienced the feelings of inefficiency that come to mind at that moment. And in the next step, when they learned Shakhty mistakes, thinking n Write the effect next to that sense, then write the alternative thinking we have taught them against this inefficient thought, and finally write their sense after substituting the alternative thought and express what percentage of them feel better. Intervention 2: Control group: Control group: The control group will participate in childbirth preparation classes routinely. Due to the increase in the sample size, each group of people are placed in groups of 8 to 12 people for counseling.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefe beyhaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences</address>
        <city>shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773943</zip>
        <telephone>+98 51 3752 3023</telephone>
        <email>abeyhaghi76@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefe beyhaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773943</zip>
        <telephone>+98 51 3752 3023</telephone>
        <email>abeyhaghi76@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Having at least primary education 2- Not having a history of mental illnesses in the past such as schizophrenia, depression, anxiety, etc. 3- Participating in childbirth preparation classes 4- Lack of doctor's instructions for absolute rest 5- Absence of chronic physical illnesses 6- Absence Addiction 7- No history of mental illness in the spouse.8_Noli Parita</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Occurrence of any stressful event for the patient or first-degree members of the pregnant woman's family, diagnosis of mental illness and psychiatric disorders (mood disorders such as depression, anxiety disorder and diagnosis of the patient with any incurable disease, etc.) during the study), Dissatisfaction and unwillingness to continue cooperation, absence of more than 2 sessions in counseling sessions, abnormalities and fetal death and termination of pregnancy before the end of counseling sessions, multiple ,Emergency cesarean section</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F53</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioural disorders associated with the puerperium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to attending childbirth preparation classes, intervention groups also attend cognitive-behavioral counseling sessions with their spouse. The Cognitive Behavioral Counseling Group will participate in 4 1-hour sessions. Due to the increase in the sample size, each group of people are placed in groups of 8 to 12 people for counseling.At the beginning of counseling classes, the informed consent form is completed in writing and the demographic profile form and the design questionnaire including grief and depression are completed.                                                                                                                          A Brief Description of Cognitive-Behavioral Couple Sessions in Research (Cognitive Therapy Techniques by Robert Lee Hee):Session 1: Establishing a good relationship and getting acquainted with the principles and goals of cognitive-behavioral couple therapy, examining and recognizing the goals of members participating in the sessions. Session 2: Identifying unrealistic beliefs and expectations of couples by providing cognitive skills Session 3: Correcting mistakes Cognitive (thinking all or nothing, exaggerated generalization, subjective filtering, neglect of the positive, hasty conclusions, mind reading, prediction, magnification, emotional reasoning, do's and don'ts, labeling, personalization and blame.), Clearing up misunderstandings Due to misconceptions or differences from each other - Replacing realistic beliefs and expectations (cognitive skills) Session 4: Teaching effective communication skills between couples (verbal and non-verbal communication, empathetic understanding and active listening) Recognizing patterns of reinforcement and punishment of each Spouses, Increasing Positive Reinforcers and Increasing Positive Behavioral Exchanges (Behavioral Skills). Homework: We teach couples in any intense and annoying emotional situation they have experienced the feelings of inefficiency that come to mind at that moment. And in the next step, when they learned Shakhty mistakes, thinking n Write the effect next to that sense, then write the alternative thinking we have taught them against this inefficient thought, and finally write their sense after substituting the alternative thought and express what percentage of them feel better.</i_keyword>
      <i_keyword>Control group: Control group: The control group will participate in childbirth preparation classes routinely. Due to the increase in the sample size, each group of people are placed in groups of 8 to 12 people for counseling.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum blues. Timepoint: Filling out the grief questionnaire by a pregnant woman before the start of counseling sessions. After the counseling sessions, the post-delivery grief questionnaire is filled in 3 to 5 days after delivery. Method of measurement: Stein Postpartum Grief Questionnaire.</prim_outcome>
      <prim_outcome>Postpartum depression. Timepoint: Completing the Postpartum Depression Questionnaire by a pregnant woman before the start of counseling sessions. After the counseling sessions, the Edinburgh Postpartum Depression Inventory will be completed on the 15th day after delivery. Method of measurement: Edinburgh Postpartum Depression Inventory.</prim_outcome>
      <prim_outcome>Intensity of labor pain. Timepoint: Intensity of labor pain during the active phase of labor (dilation 4 cm) is filled in three stages. Method of measurement: Visual scale of pain.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-01</approval_date>
        <contact_name>Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud, 7th of Tir Square - Shahroud University of Medical Sciences and Health Services shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
