<?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>IRCT20210407050883N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-25</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of supportive counseling on self-esteem and self-efficacy of infertile women after IVF failure</public_title>
      <acronym></acronym>
      <scientific_title>The effect of supportive counseling on self-esteem and self-efficacy of infertile women after IVF failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56331</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This analysis is only performed on patients who have completed all stages of counseling correctly - generalizing the results to the community should be done with caution, Randomization description: Randomization method: simple randomization
Randomization tool: statistical software(Random allocation software)
How to make a random sequence: They are selected as available and are randomly placed in each of the groups using a simple random sequence.
Hide allocation: using randomly sealed opaque envelopes with random sequence.</study_design>
      <phase>N/A</phase>
      <hc_freetext>It is not a disease.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": Support counseling in 4 sessions (28), two face-to-face sessions and two face-to-face sessions - virtual and each session for 45 to 60 minutes and each week with the content of the first session (individual-face-to-face): reassuring and explanation (establishing a positive relationship, resolving Patient misunderstandings and doubts and pointing out potential abilities and potentials and reducing stress by clarifying and providing information and explanation on the subject under discussion, Jacobsen relaxation training)،Second and third sessions (individual-virtual): guidance, encouragement and persuasion (online virtual individual counseling with the content of the first session feedback, explanation of various assisted reproductive methods, treatment protocols, experience of successful mothers, providing success statistics of reproductive assistive methods), fourth session (Individual-face-to-face): Vacation (practicing the techniques of revealing and discharging emotions, psychological support by active and empathetic listening, and a positive and unconditional outlook on life) is provided. Intervention 2: "Control group":in the first session coordinated by the clients at the Infertility Center, the Demographic Characteristics Questionnaire, Eysenck Self-Esteem Questionnaire and Cousinio (2006) Infertility Self-Efficacy Questionnaire were completed and routine care provided at  Milad Infertility Center was included. With how to continue treatment is assisted reproduction.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Manijeh Shafaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina St., Ph.D. Crossroads, School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Shafaghim2@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fatemeh Zahra Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Street, Doctoral Crossroads, School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Karimifz@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of primary infertility
Negative pregnancy test following failure of the first IVf
Iranian and resident of Mashhad
ability to speak and write in Persian
No known medical conditions
do not smoke or drink alcohol
Has a smartphone or any electronic device with the ability to connect to the Internet
Satisfaction to participate in the study
Do not have a mental illness</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Occurrence of stressful events during the study
Not attending one of the counseling sessions,
participating in other training and counseling sessions while studying</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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": Support counseling in 4 sessions (28), two face-to-face sessions and two face-to-face sessions - virtual and each session for 45 to 60 minutes and each week with the content of the first session (individual-face-to-face): reassuring and explanation (establishing a positive relationship, resolving Patient misunderstandings and doubts and pointing out potential abilities and potentials and reducing stress by clarifying and providing information and explanation on the subject under discussion, Jacobsen relaxation training)،Second and third sessions (individual-virtual): guidance, encouragement and persuasion (online virtual individual counseling with the content of the first session feedback, explanation of various assisted reproductive methods, treatment protocols, experience of successful mothers, providing success statistics of reproductive assistive methods), fourth session (Individual-face-to-face): Vacation (practicing the techniques of revealing and discharging emotions, psychological support by active and empathetic listening, and a positive and unconditional outlook on life) is provided.</i_keyword>
      <i_keyword>"Control group":in the first session coordinated by the clients at the Infertility Center, the Demographic Characteristics Questionnaire, Eysenck Self-Esteem Questionnaire and Cousinio (2006) Infertility Self-Efficacy Questionnaire were completed and routine care provided at  Milad Infertility Center was included. With how to continue treatment is assisted reproduction</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Infertility self-efficacy. Timepoint: At the beginning of the study and 4 weeks after the intervention. Method of measurement: Infertility self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Self-esteem. Timepoint: At the beginning of the study and 4 weeks after the intervention. Method of measurement: Eysenck Self-esteem 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-20</approval_date>
        <contact_name>Mashhad University of Medical Sciences and Health Services</contact_name>
        <contact_address>Khorasan Razavi - Mashhad - University Street - in front of University Alley 18 - Mashhad University of Medical Sciences - Vice Chancellor for Research and Technology Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
