<?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>IRCT20230426058001N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-21</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>the effect of  counseling on the sexual self-esteem and genital self-image</public_title>
      <acronym></acronym>
      <scientific_title>the effect of cognetive-behavioral group counseling on the sexual self-esteem and genital self-image  in the women seeking genital cosmetic surgry</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69784</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A randomized clinical trial with a pre-test and post-test plan will be conducted on 70 women applying for genital cosmetic surgery (before and after cosmetic surgery) referring to private offices and clinics and beauty centers in Neishabur city. After obtaining permission from the ethics committee of the university and receiving a letter of introduction from the research vice-chancellor of the Mashhad Midwifery Nursing School, the researcher will conduct sampling by visiting beauty clinics and gynecologists' offices daily. Sampling will be done among the eligible applicants for genital cosmetic surgery by the available method.
Then the objectives and method of the research will be explained to them by the researcher. If they are willing and meet the entry criteria, written consent will be obtained from them to enter the research. Then they will be randomly divided into intervention and control groups.
Randomization Unit: Individual

How to make a random sequence: Permuted block randomization with a block size of four

How people enter the random sequence: according to the sequence created by the Random Allocation Software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Healthy people willing to undergo unnecessary cosmetic surgery.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, group cognitive-behavioral counseling is held face-to-face in 8 sessions of 90 minutes twice a week. The number of women present in the meetings will be 11-12 people (three groups). The content of the sessions includes: introduction, explanation of the work method and the type of counseling and the research goal of people's cognitive reconstruction, including the process of identifying and evaluating ineffective and unhelpful spontaneous thoughts, as well as ineffective coping behaviors. In the field of self-image and body image and sexual self-esteem, identifying and evaluating cognitive distortions, realistically looking at the individual valuation system, identifying strengths and weaknesses and correcting them. At the end of each. Intervention 2: Control group: Women applying for genital cosmetic surgery who will not receive any advice.</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 The results are only in the form of printing the article after finishing the work</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamide Sadat Mollanorouzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 Vali Asr Street, Taban Building, Plate 85, 6th Floor.</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9318743745</zip>
        <telephone>+98 51 4263 4350</telephone>
        <email>mollanorouzih981@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kobra Mirzakhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad St.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9138813944</zip>
        <telephone>+98 51 3841 2081</telephone>
        <email>MirzakhaniK@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be Iranian
Not pregnant
Not menopause
There is no medical indication for genital cosmetic surgery according to the gynecologist's opinion.
have written informed consent to participate in the research
Be between 18 and 50 years old
Apply for genital cosmetic surgery
Have at least a cycle certificate and a smartphone
Don't have severe stress, anxiety and depression
Do not participate in cognitive behavioral counseling or training classes at the same time
There should be no addiction to alcohol and drugs in the woman and her husband
Unfortunate incidents have not happened to him in the last 6 months.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to participate in more than two counseling sessions
Occurrence of accidents during the study
Incomplete completion of questionnaires (response rate less than 90%)</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, group cognitive-behavioral counseling is held face-to-face in 8 sessions of 90 minutes twice a week. The number of women present in the meetings will be 11-12 people (three groups). The content of the sessions includes: introduction, explanation of the work method and the type of counseling and the research goal of people's cognitive reconstruction, including the process of identifying and evaluating ineffective and unhelpful spontaneous thoughts, as well as ineffective coping behaviors. In the field of self-image and body image and sexual self-esteem, identifying and evaluating cognitive distortions, realistically looking at the individual valuation system, identifying strengths and weaknesses and correcting them. At the end of each</i_keyword>
      <i_keyword>Control group: Women applying for genital cosmetic surgery who will not receive any advice.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changing the sexual self-esteem score. Timepoint: Before the start of the intervention and  one month after the end of the intervention (counseling sessions). Method of measurement: Zina and Schwarz sexual self-esteem questionnaire - shortened form.(SSEI-W-SF).</prim_outcome>
      <prim_outcome>Changing the genital self-image score. Timepoint: Before the start of the intervention and  one month after the end of the intervention (counseling sessions). Method of measurement: Genital self-image questionnaire.(FGSIS).</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>2023-03-04</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>University St., Ibn Sina St., Dr. Crossroad, Faculty of Nursing and Midwifery Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
