<?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>IRCT20220926056046N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-28</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of psychodrama on postpartum anxiety in women with traumatic birth experiences.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of psychodrama-based group therapy counseling on postpartum anxiety in women with traumatic childbirth experience: A randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/86893</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling will be done by convenience sampling and according to the inclusion and exclusion criteria. Participants will be randomly assigned to the intervention and control groups using RAS (Random Allocation Software) with stratified blocks (based on being prime and multiparous) with block sizes of 4 and 6 and with a ratio of 1:1. The allocation of women will be done by a person not involved in the sampling. To conceal the allocation, the type of allocation will be written on paper and placed in consecutively numbered opaque envelopes (Allocation Concealment). The envelopes will be opened in the order of the participants’ names in the study and by a person not involved in the study.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Postpartum depression. Condition 2: Postpartum anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the intervention group, 6 sessions (once a week) of psychodrama-based intervention will be held in groups of 4-5 people for 45-60 minutes in a group and in person at the health center/hospital. The implementation of psychodrama will be carried out by a trained student under the supervision of an expert psychologist (consulting professor). In the intervention group, homework will be given to the individuals at the end of each session, and a review of the previous session will be conducted at the beginning of each session. A text message will be sent to the individuals each week to remind them of the assignments and sessions. Participants will receive free internet incentives to motivate them to do their homework each week. The researcher's contact number and email will be provided to the intervention group so that they can express their questions and talk confidentially if needed. The content of the sessions includes: Session 1: General session: Getting to know each other, building trust and group cohesion; Session objectives: Explaining the concept of psychodrama and the goals of group therapy and the effect of group activity on solving problems by the therapist; Introducing members and talking about their current discomfort and experiences related to traumatic childbirth; creating a sense of psychological safety; Session techniques: Warm-up games such as introducing yourself with a positive characteristic; Sociometry technique; free discussion about shared feelings after childbirth; explaining the framework of the sessions and group rules. Session 2: Session overview: Recognizing feelings and experiences of childbirth; Session objectives: Expressing the personal experience of childbirth; Identifying repressed feelings such as sadness, fear, anger, loneliness, worry, etc. and expressing them through physical exercises and alternating expressions on the face and body; Session techniques: Drawing a picture of the childbirth experience; Using the monologue technique (each person talks about their experience); playing a short role of a difficult childbirth scene; group reflection and empathy. Session 3: Session overview: Role-playing a traumatic scene; Session objectives: Reconstructing and discharging emotions related to traumatic childbirth after physical and expressive exercises and warming up, using stage props, music, and other clients in the form of defined roles; Reducing anxiety related to the memory of childbirth; Accurately simulating traumatic situations for each client; Session techniques: Choosing a protagonist (one of the members); Performing a complete psychodrama with the help of egos (auxiliary characters); Working with feelings of fear, anger, and helplessness; Technique of “changing the ending of the scene” in a healthier way. Session 4: Session overview: Working with the maternal role and female identity; Session objectives: Identifying negative beliefs about motherhood after warming up exercises; Reconstructing the maternal role in the individual’s mind; Performing unpleasant experiences and dysfunctional feelings and thoughts of the protagonist by the egos and watching their own experiences from the perspective of the protagonist. Spectator; Session techniques: Double technique: reflection of the individual's hidden feelings by the therapist or another member; role-playing in the form of a conversation with the "critical self"; conversation with the "ideal mother self"; reconstruction of the positive maternal role; continued accurate simulation of the life situations of each client. Session five: General session: strengthening internal resources and social support; Session objectives: activating internal and external support resources; increasing the sense of maternal adequacy; consciously repeating the bitter and unpleasant experiences of the clients and forming a pleasant and controllable experience; continued accurate simulation of the life situations of each client; Session techniques: working with an empty chair (conversation with a source of support such as mother or spouse or God); visualizing a capable self and a successful mother; writing a supportive message to the future self; practicing relaxation and self-care. Session six: General session: summary, farewell and evaluation; Session objectives: reviewing previous sessions and the path taken; evaluating constructive individual changes in the members' relationships; increasing awareness, empathy and confrontation in social interactions; Discovering new patterns and reducing conflicts; clarifying roles, interpersonal relationships, values, and revealing new desirable feelings, thoughts, and behaviors that are fruitful through group solidarity; preparing for the end of sessions; session techniques: reviewing initial feelings and current changes; drawing a chart of personal change; writing a letter to the pre-treatment self; group farewell ritual and transferring support outside the group. Intervention 2: Control group: The control group will be provided with routine postpartum education, care, and counseling. After the intervention, if the results are significant and the psychodrama has a positive effect on the main outcome of the study, a virtual group counseling session will be held for the control group upon their request and willingness.</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 Participant data is confidential.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Solmaz Ghanbari Homaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, South Shariati Street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3477 0648</telephone>
        <email>homayisolmaz@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Solmaz Ghanbari Homaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, South Shariati Street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3477 0648</telephone>
        <email>homayisolmaz@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>
    </countries>
    <criteria>
      <inclusion_criteria>Term delivery
Singleton birth
Living in Tabriz city or its suburbs
Having experienced traumatic vaginal birth based on the Childbirth Experiences Questionnaire version 2.0 (CEQ 2.0) and a mean score lower than 2.5
Obtaining an anxiety score higher than 28 based on a specific postpartum anxiety questionnaire
Having a smart phone
Internet access
Education level: Elementary school completion and above</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having post-traumatic stress syndrome (PTSD) based on the Post-Traumatic Stress Symptom Scale (PSS_1) questionnaire
History of depression or postpartum depression based on maternal self-report or medical record review or score of 13 or higher on the Edinburgh Depression Questionnaire or mental illness based on self-report or medical record review
Participating in two studies simultaneously
Use of antidepressants based on medical record review
The occurrence of a stressful life event, such as divorce, death of a close family member, and diagnosis of a terminal or incurable disease for a family member within three months prior to data collection.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F53</hc_code>
      <hc_code>F41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Puerperal psychosis</hc_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the intervention group, 6 sessions (once a week) of psychodrama-based intervention will be held in groups of 4-5 people for 45-60 minutes in a group and in person at the health center/hospital. The implementation of psychodrama will be carried out by a trained student under the supervision of an expert psychologist (consulting professor). In the intervention group, homework will be given to the individuals at the end of each session, and a review of the previous session will be conducted at the beginning of each session. A text message will be sent to the individuals each week to remind them of the assignments and sessions. Participants will receive free internet incentives to motivate them to do their homework each week. The researcher's contact number and email will be provided to the intervention group so that they can express their questions and talk confidentially if needed. The content of the sessions includes: Session 1: General session: Getting to know each other, building trust and group cohesion; Session objectives: Explaining the concept of psychodrama and the goals of group therapy and the effect of group activity on solving problems by the therapist; Introducing members and talking about their current discomfort and experiences related to traumatic childbirth; creating a sense of psychological safety; Session techniques: Warm-up games such as introducing yourself with a positive characteristic; Sociometry technique; free discussion about shared feelings after childbirth; explaining the framework of the sessions and group rules. Session 2: Session overview: Recognizing feelings and experiences of childbirth; Session objectives: Expressing the personal experience of childbirth; Identifying repressed feelings such as sadness, fear, anger, loneliness, worry, etc. and expressing them through physical exercises and alternating expressions on the face and body; Session techniques: Drawing a picture of the childbirth experience; Using the monologue technique (each person talks about their experience); playing a short role of a difficult childbirth scene; group reflection and empathy. Session 3: Session overview: Role-playing a traumatic scene; Session objectives: Reconstructing and discharging emotions related to traumatic childbirth after physical and expressive exercises and warming up, using stage props, music, and other clients in the form of defined roles; Reducing anxiety related to the memory of childbirth; Accurately simulating traumatic situations for each client; Session techniques: Choosing a protagonist (one of the members); Performing a complete psychodrama with the help of egos (auxiliary characters); Working with feelings of fear, anger, and helplessness; Technique of “changing the ending of the scene” in a healthier way. Session 4: Session overview: Working with the maternal role and female identity; Session objectives: Identifying negative beliefs about motherhood after warming up exercises; Reconstructing the maternal role in the individual’s mind; Performing unpleasant experiences and dysfunctional feelings and thoughts of the protagonist by the egos and watching their own experiences from the perspective of the protagonist. Spectator; Session techniques: Double technique: reflection of the individual's hidden feelings by the therapist or another member; role-playing in the form of a conversation with the "critical self"; conversation with the "ideal mother self"; reconstruction of the positive maternal role; continued accurate simulation of the life situations of each client. Session five: General session: strengthening internal resources and social support; Session objectives: activating internal and external support resources; increasing the sense of maternal adequacy; consciously repeating the bitter and unpleasant experiences of the clients and forming a pleasant and controllable experience; continued accurate simulation of the life situations of each client; Session techniques: working with an empty chair (conversation with a source of support such as mother or spouse or God); visualizing a capable self and a successful mother; writing a supportive message to the future self; practicing relaxation and self-care. Session six: General session: summary, farewell and evaluation; Session objectives: reviewing previous sessions and the path taken; evaluating constructive individual changes in the members' relationships; increasing awareness, empathy and confrontation in social interactions; Discovering new patterns and reducing conflicts; clarifying roles, interpersonal relationships, values, and revealing new desirable feelings, thoughts, and behaviors that are fruitful through group solidarity; preparing for the end of sessions; session techniques: reviewing initial feelings and current changes; drawing a chart of personal change; writing a letter to the pre-treatment self; group farewell ritual and transferring support outside the group.</i_keyword>
      <i_keyword>Control group: The control group will be provided with routine postpartum education, care, and counseling. After the intervention, if the results are significant and the psychodrama has a positive effect on the main outcome of the study, a virtual group counseling session will be held for the control group upon their request and willingness.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum anxiety. Timepoint: Before the start of the intervention, 4 weeks after the end of the intervention. Method of measurement: Postpartum Specific Anxiety Scale-Research Short-Form (PSAS-RSF).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postpartum depression. Timepoint: Before the intervention, 4 weeks after the end of the intervention, controlling for the effect of the baseline score. Method of measurement: Edinburgh Postpartum Depression Scale (EPDS).</sec_outcome>
      <sec_outcome>Maternal function. Timepoint: Before the intervention, 4 weeks after the end of the intervention, controlling for the effect of the baseline score. Method of measurement: Barkin Index of Maternal Functioning (BIMF).</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>2025-10-06</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Central Building, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, Iran. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
