<?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>IRCT20210403050822N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-22</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effectiveness of Acceptance and Commitment Therapy on sexual self-esteem and couple burnout of infertile women</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Acceptance and Commitment Therapy on sexual self-esteem and couple burnout of infertile women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>4</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55327</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>infertile women.</hc_freetext>
      <i_freetext>Individual training with an approach based on acceptance and commitment, which is held in the form of 8 sessions two hours a week .Step A Baseline measurement using a questionnaire, Step B Intervention and re-measurement with a questionnaire, Step C Follow up the effects of the intervention after its completion.Acceptance and commitment therapy (ACT) has six central processes that lead to psychological flexibility. These six processes are: "acceptance, failure, self as context, present-day communication, recognizing values, and committed action." Acceptance and commitment therapy, in fact, is not intended to bring about a direct change in clients, but rather to help clients to relate to their experiences in different ways and to be able to fully live a meaningful and value-based life. (Protocol based on Hayes, Estrosal, and Wilson's book of Acceptance and Commitment). Intervention group: There are 4 infertile women who complete marital boredom with full insertion of details in the pre-test of sexual self-esteem form questionnaires before implementing the protocol. In the intervention group, the treatment protocol based on acceptance and commitment (act) will be held during 8 sessions of 2 hours. During the treatment and after that, questionnaires will be used to evaluate the changes..</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only part of the data, such as information about the main outcome or the like, can be shared

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Accurate reading of study and researcher information for reference without changing it

Where to obtain:
Email addresses, telephone numbers

How to obtain:
Send a request via email and check the cause and rank of the university and receive a response

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sadaf Town, Mehdi Bayat St., North Bahman Alley, No. 48, Unit 5</address>
        <city>Andishe</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3168963489</zip>
        <telephone>+98 21 6557 7990</telephone>
        <email>Elham.asadi7488@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sadaf Town, Mehdi Bayat St., North Bahman Alley, No. 48, Unit 5</address>
        <city>Andishe</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3168963489</zip>
        <telephone>+98 21 6557 7990</telephone>
        <email>elham.asadi7488@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>aged 20 years to 40 years
At least four years of cohabitation (duration of infertility awareness for at least two years)
Infertility due to female physical problems (ovulation disorders, uterine tube disorders, endometriosis, immune system problems) and its diagnosis and approval by a gynecologist according to her medical record at the Infertility Center
Failure to confirm false infertility (due to fertility stress) using the initial interview</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Major psychiatric disorder
History of hospitalization in psychiatric department
Use of psychiatric drugs (according to the medical record and using interviews and confidentiality of clients)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Individual training with an approach based on acceptance and commitment, which is held in the form of 8 sessions two hours a week .Step A Baseline measurement using a questionnaire, Step B Intervention and re-measurement with a questionnaire, Step C Follow up the effects of the intervention after its completion.Acceptance and commitment therapy (ACT) has six central processes that lead to psychological flexibility. These six processes are: "acceptance, failure, self as context, present-day communication, recognizing values, and committed action." Acceptance and commitment therapy, in fact, is not intended to bring about a direct change in clients, but rather to help clients to relate to their experiences in different ways and to be able to fully live a meaningful and value-based life. (Protocol based on Hayes, Estrosal, and Wilson's book of Acceptance and Commitment). Intervention group: There are 4 infertile women who complete marital boredom with full insertion of details in the pre-test of sexual self-esteem form questionnaires before implementing the protocol. In the intervention group, the treatment protocol based on acceptance and commitment (act) will be held during 8 sessions of 2 hours. During the treatment and after that, questionnaires will be used to evaluate the changes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual self-esteem of infertile women. Timepoint: Before and during the intervention and after the intervention. Method of measurement: Sexual Self-Esteem Index for Woman-Short Form (SSEI-W-SF).</prim_outcome>
      <prim_outcome>Marital boredom of infertile women. Timepoint: Before and during the intervention and after the intervention. Method of measurement: Couple burnout questionnaire (CBM) of Pines.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical dimension of marital boredom. Timepoint: Before, during and after the study. Method of measurement: Pineas Marital Boredom Questionnaire.</sec_outcome>
      <sec_outcome>Emotional dimension of marital boredom. Timepoint: Before, during and after the study. Method of measurement: Pineas Marital Boredom Questionnaire.</sec_outcome>
      <sec_outcome>Mental dimention of marital boredom. Timepoint: Before, during and after the study. Method of measurement: Pineas Marital Boredom Questionnaire.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-04</approval_date>
        <contact_name>Ethics Committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Sadaf Town, Mehdi Bayat St., North Bahman Alley, No. 48, Unit 5 Andishe Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
