<?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)>

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          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>IRCT20201216049732N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effectiveness of Schema Therapy and Compassion-Focused Therapy on Marital Satisfaction, Maladaptive Schemas, Self-efficacy and Mind Rumination</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Schema Therapy and Compassion-Focused Therapy on Marital Satisfaction, Maladaptive Schemas, Self-efficacy and Mind Rumination in student Married Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53214</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Schema Therapy. Condition 2: Compassion-focused Therapy. Condition 3: Marital Satisfaction. Condition 4: Maladaptive Schemas. Condition 5: Self-efficacy. Condition 6: Mind Rumination.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Schema therapy is performed on participants in 8 sessions of 90 minutes. Description of training sessions Schema therapy Session Title Sessions of the first session: Communication and initial evaluation, - Communication and introduction of members Objectives of the session: - Explaining the rules of the group and goals and introduction of the course - Commitment - Recognizing the current problem Assignments: Each person in the next few days Take care of your spouse and others and identify your current problems. Then write these problems specifically according to the description of the session and in return write your goals about the problem according to the course of treatment. Session 2: Teaching about schemas and coping styles Objectives of the sessions: - Teaching maladaptive schemas, Types and characteristics - Explaining coping styles - Communicating the problems of current life and schemas Homework: People should read the information sheet about schemas well and consider some situations that they suffer from in their married life. And write the type of schema that is evoked and related to it at the time, and identify their coping styles to cope with that schema. Session 3: Cognitive strategies. Objectives of the sessions: - Presenting the logic of the technique Cognitive theories and metaphors of war - Implementation of schema validity test - Use of empathetic coping therapy style - New definition of evidence confirming schema. Assignments: Individuals should consider some of the schematic behaviors until the next session, write down the underlying schema, the evidence confirming and rejecting it. Session 4: Cognitive techniques. Objectives of the sessions: - Evaluating the advantages and disadvantages of people's coping responses - Establishing a dialogue between the schema aspect and the healthy aspect - Using the devil defender game - Training, development and educational structures. Assignments: Individuals at home establish a dialogue between the schematic aspect and their healthy aspect using the empty chair technique. Session 5: Experimental Strategies. Objectives of the sessions: - Presenting the logic of the experimental technique and its goals - Mental imagery - Relating the mental image of the past to the present - Conducting imaginary dialogue. Assignments: Write a letter to a person who was harmed during childhood and did not send it and bring it with them to the meeting. Session 6: Behavioral model breaking. Objectives of the sessions: - Presenting the logic of behavioral techniques - Expressing the purpose of behavioral techniques - Determining a comprehensive list of specific behaviors as a subject of change - Providing ways to prepare a list of behaviors - Prioritizing behaviors for modeling and identifying the most problematic - Increasing motivation for change Behavior. Assignments: Over the next few days, people will consider some frustrated situations in life and pay attention to how they felt, what they thought, and what they did, and in the event of problematic behavior, a healthy alternative to the opposite. Write it. Session 7: Behavioral techniques. Objectives of the sessions: - Increasing motivation to change behavior - Practicing healthy behaviors through illustration and role-playing - Overcoming barriers to behavior change - Making important changes in life. Assignments: Ask people for behavior that has not yet changed by asking themselves, "What would I do if I didn't have this schema?" Find alternative behaviors and write down the advantages and disadvantages of change over non-change. Session 8: Conclusion. Objectives of the sessions: Summary of previous sessions - Review of completed assignments and troubleshooting - Conclusion and final conclusion with the help of members - Presentation of relevant post-test - Thanks and goodbye. Intervention 2: Intervention group 2: Compassion-focused therapy is performed in 8 sessions of 90 minutes. The following is a brief description of the sessions. Session 1: Familiarity with the general principles of treatment. Content of the sessions: Establishing initial communication, grouping, reviewing the structure of the sessions, getting acquainted with the general principles of compassion-focused treatment, evaluating and evaluating the level of emotional and self-harm of members, describing and explaining emotional harassment and factors related to its symptoms and conceptualizing education Self-compassion. Homework: Record emotional and self-critical harassment in daily activities and challenges. Expected Behavior: Identify and be aware of self-criticism. Session 2: Recognizing the components of self-compassion Content of the sessions: Identifying and introducing the components of compassion, examining each component of compassion in members and identifying its characteristics, getting acquainted with the characteristics of people with compassion and reviewing the compassion of members themselves. Homework: Recording the components of self-sufficiency in daily activities. Expected Behavior: Identify and be aware of the components of self-compassion. Session 3: Self-compassion education of members. Content of the sessions: reviewing the tasks of the previous session, cultivating a feeling of warmth and kindness towards oneself, cultivating and understanding that others also have flaws and problems (cultivating a sense of human commonalities) in the face of self-destructive feelings, shame, self-compassion; Form and create more and more diverse feelings related to people's issues to increase care and attention to their health. Homework: Recording the components of self-sufficiency in daily activities. Expected Behavior: Identify and be aware of the components of self-compassion. Session 4: Self-knowledge and identification of self-critical factors. Content of the sessions: Reviewing the previous session, encouraging the subjects to self-knowledge and examining their personality as a "compassionate person" or "determining compassion", identifying and applying the exercises of "cultivating a compassionate mind" (the value of self-compassion, empathy and compassion To teach oneself and others, teaching the physiotherapist metaphor), making mistakes and forgiving oneself for mistakes to speed up change. Homework: Recording daily mistakes and identifying the factors of expected behavior: Cultivating self-sufficiency. Session 5: Correction and expansion of compassion. Content of the sessions: Review of the previous session's practice, familiarity and application of "compassionate mind training exercises" (forgiveness, acceptance without judgment, teaching the flu metaphor and training of misery), training to accept problems, accepting changes ahead and enduring difficult and challenging situations with Paying attention to the changing nature of life and people facing different challenges. Homework: Forgiveness and acceptance without judgment in challenging daily activities and recording this expected behavior: Improving and developing self-sufficiency. Session 6: Teaching styles and methods of expressing compassion. Content of the sessions: Review of the previous session, practical practice of creating compassionate images, teaching styles and methods of expressing compassion (verbal compassion, practical compassion, intermittent compassion and continuous compassion), and applying these methods in daily life and for the family and Friends, teach the development of valuable and transcendent emotions. Home exercise: Applying compassion in daily activities. Expected Behavior: Feeling worthwhile and self-sufficient. Session 7: Compassion Techniques. Content of the sessions: Reviewing the practice of the previous session, learning to write compassionate letters for oneself and others, teaching recording methods and daily notes of real situations based on compassion and the individual's performance in those situations. Homework: Write compassionate letters to yourself and others. Expected Behavior: Improving Self-Sufficiency and Self-Esteem. Session 8: Evaluation and application. Content of the sessions: Training and practicing the skills, reviewing and practicing the skills presented in the previous sessions to help the subjects to cope with different life situations in different ways, and finally summarizing and presenting solutions to maintain and apply this Therapeutic methods in daily life Home exercise: recording and recording self-sufficiency in daily challenges. Expected behavior: cultivating and growing self-sufficiency. Intervention 3: Control group: Does not receive any intervention.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mansoreh nasirharand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farhangshahr, Islamic Azad University</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۱۳۴۹۳۷۳۳۳</zip>
        <telephone>+98 61 3334 8421</telephone>
        <email>info@iauahvaz.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansoreh Nasirharand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farhangshahr, Islamic Azad University</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۱۳۴۹-۳۷۳۳۳</zip>
        <telephone>+98 61 3334 8320</telephone>
        <email>info@iauahvaz.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No mental disorders
Marriage history between 1 to 5 years
Minimum  Level of education diploma</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Receive any psychological interventions and counseling just before starting work
Taking psychiatric drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Schema therapy is performed on participants in 8 sessions of 90 minutes. Description of training sessions Schema therapy Session Title Sessions of the first session: Communication and initial evaluation, - Communication and introduction of members Objectives of the session: - Explaining the rules of the group and goals and introduction of the course - Commitment - Recognizing the current problem Assignments: Each person in the next few days Take care of your spouse and others and identify your current problems. Then write these problems specifically according to the description of the session and in return write your goals about the problem according to the course of treatment. Session 2: Teaching about schemas and coping styles Objectives of the sessions: - Teaching maladaptive schemas, Types and characteristics - Explaining coping styles - Communicating the problems of current life and schemas Homework: People should read the information sheet about schemas well and consider some situations that they suffer from in their married life. And write the type of schema that is evoked and related to it at the time, and identify their coping styles to cope with that schema. Session 3: Cognitive strategies. Objectives of the sessions: - Presenting the logic of the technique Cognitive theories and metaphors of war - Implementation of schema validity test - Use of empathetic coping therapy style - New definition of evidence confirming schema. Assignments: Individuals should consider some of the schematic behaviors until the next session, write down the underlying schema, the evidence confirming and rejecting it. Session 4: Cognitive techniques. Objectives of the sessions: - Evaluating the advantages and disadvantages of people's coping responses - Establishing a dialogue between the schema aspect and the healthy aspect - Using the devil defender game - Training, development and educational structures. Assignments: Individuals at home establish a dialogue between the schematic aspect and their healthy aspect using the empty chair technique. Session 5: Experimental Strategies. Objectives of the sessions: - Presenting the logic of the experimental technique and its goals - Mental imagery - Relating the mental image of the past to the present - Conducting imaginary dialogue. Assignments: Write a letter to a person who was harmed during childhood and did not send it and bring it with them to the meeting. Session 6: Behavioral model breaking. Objectives of the sessions: - Presenting the logic of behavioral techniques - Expressing the purpose of behavioral techniques - Determining a comprehensive list of specific behaviors as a subject of change - Providing ways to prepare a list of behaviors - Prioritizing behaviors for modeling and identifying the most problematic - Increasing motivation for change Behavior. Assignments: Over the next few days, people will consider some frustrated situations in life and pay attention to how they felt, what they thought, and what they did, and in the event of problematic behavior, a healthy alternative to the opposite. Write it. Session 7: Behavioral techniques. Objectives of the sessions: - Increasing motivation to change behavior - Practicing healthy behaviors through illustration and role-playing - Overcoming barriers to behavior change - Making important changes in life. Assignments: Ask people for behavior that has not yet changed by asking themselves, "What would I do if I didn't have this schema?" Find alternative behaviors and write down the advantages and disadvantages of change over non-change. Session 8: Conclusion. Objectives of the sessions: Summary of previous sessions - Review of completed assignments and troubleshooting - Conclusion and final conclusion with the help of members - Presentation of relevant post-test - Thanks and goodbye.</i_keyword>
      <i_keyword>Intervention group 2: Compassion-focused therapy is performed in 8 sessions of 90 minutes. The following is a brief description of the sessions. Session 1: Familiarity with the general principles of treatment. Content of the sessions: Establishing initial communication, grouping, reviewing the structure of the sessions, getting acquainted with the general principles of compassion-focused treatment, evaluating and evaluating the level of emotional and self-harm of members, describing and explaining emotional harassment and factors related to its symptoms and conceptualizing education Self-compassion. Homework: Record emotional and self-critical harassment in daily activities and challenges. Expected Behavior: Identify and be aware of self-criticism. Session 2: Recognizing the components of self-compassion Content of the sessions: Identifying and introducing the components of compassion, examining each component of compassion in members and identifying its characteristics, getting acquainted with the characteristics of people with compassion and reviewing the compassion of members themselves. Homework: Recording the components of self-sufficiency in daily activities. Expected Behavior: Identify and be aware of the components of self-compassion. Session 3: Self-compassion education of members. Content of the sessions: reviewing the tasks of the previous session, cultivating a feeling of warmth and kindness towards oneself, cultivating and understanding that others also have flaws and problems (cultivating a sense of human commonalities) in the face of self-destructive feelings, shame, self-compassion; Form and create more and more diverse feelings related to people's issues to increase care and attention to their health. Homework: Recording the components of self-sufficiency in daily activities. Expected Behavior: Identify and be aware of the components of self-compassion. Session 4: Self-knowledge and identification of self-critical factors. Content of the sessions: Reviewing the previous session, encouraging the subjects to self-knowledge and examining their personality as a "compassionate person" or "determining compassion", identifying and applying the exercises of "cultivating a compassionate mind" (the value of self-compassion, empathy and compassion To teach oneself and others, teaching the physiotherapist metaphor), making mistakes and forgiving oneself for mistakes to speed up change. Homework: Recording daily mistakes and identifying the factors of expected behavior: Cultivating self-sufficiency. Session 5: Correction and expansion of compassion. Content of the sessions: Review of the previous session's practice, familiarity and application of "compassionate mind training exercises" (forgiveness, acceptance without judgment, teaching the flu metaphor and training of misery), training to accept problems, accepting changes ahead and enduring difficult and challenging situations with Paying attention to the changing nature of life and people facing different challenges. Homework: Forgiveness and acceptance without judgment in challenging daily activities and recording this expected behavior: Improving and developing self-sufficiency. Session 6: Teaching styles and methods of expressing compassion. Content of the sessions: Review of the previous session, practical practice of creating compassionate images, teaching styles and methods of expressing compassion (verbal compassion, practical compassion, intermittent compassion and continuous compassion), and applying these methods in daily life and for the family and Friends, teach the development of valuable and transcendent emotions. Home exercise: Applying compassion in daily activities. Expected Behavior: Feeling worthwhile and self-sufficient. Session 7: Compassion Techniques. Content of the sessions: Reviewing the practice of the previous session, learning to write compassionate letters for oneself and others, teaching recording methods and daily notes of real situations based on compassion and the individual's performance in those situations. Homework: Write compassionate letters to yourself and others. Expected Behavior: Improving Self-Sufficiency and Self-Esteem. Session 8: Evaluation and application. Content of the sessions: Training and practicing the skills, reviewing and practicing the skills presented in the previous sessions to help the subjects to cope with different life situations in different ways, and finally summarizing and presenting solutions to maintain and apply this Therapeutic methods in daily life Home exercise: recording and recording self-sufficiency in daily challenges. Expected behavior: cultivating and growing self-sufficiency.</i_keyword>
      <i_keyword>Control group: Does not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Marital Satisfaction. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Enrich Marital Satisfaction Questionnaire.</prim_outcome>
      <prim_outcome>Maladaptive Schemas. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Yang Maladaptive Schema Questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Scherer General Self-Efficacy Questionnaire.</prim_outcome>
      <prim_outcome>Mind Rumination. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Yousefi Mind Rumination Questionnaire.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-28</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Ahvaz Branch</contact_name>
        <contact_address>Farhangshahr Ave, Islamic Azad University Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
