<?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>IRCT20240601061975N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-08</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The impact of online solution-focused group counseling on the sexual quality of life and marital adjustment of women after hysterectomy</public_title>
      <acronym></acronym>
      <scientific_title>The impact of online solution-focused group counseling on the sexual quality of life and marital adjustment of women after hysterectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77150</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Patients will be randomly assigned to study groups using a block randomization method with block sizes of 2 and 4. This will be done using the website https://www.sealedenvelope.com/.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual Quality of Life After Hysterectomy, Marital Adjustment After Hysterectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receive 6 online coaching sessions based on the Solution-Focused approach. Intervention 2: Control group: It 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The study data includes sexual quality of life scores, marital adjustment scores, demographic characteristics, and information related to hysterectomy awareness questionnaires. This data will be reported solely as numbers and average scores; the names of participants will remain confidential with the researcher.

When:
Access will begin, along with the printing of related research papers.

To whom:
The thesis will be accessible to medical researchers and students in Mashhad, and related articles will be available to all researchers.

Conditions:
Individuals affiliated with scientific organizations and institutions may use this material for their research, upon request and with proper attribution and referencing of the relevant study.

Where to obtain:
Contact the responsible author via email.

How to obtain:
After receiving an applicant's email, which includes their introduction and type of request, the responsible writer will review the necessary information and send it to the applicant as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Zahra Hadizade Talasaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square, Eastern Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Khwarazmi Educational Complex</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3884 6730</telephone>
        <email>hadizadehz@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Zahra Hadizade Talasaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square, Eastern Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Khwarazmi Educational Complex</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3884 6730</telephone>
        <email>hadizadehz@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Hysterectomy for benign reasons (bleeding, mass, prolapse, pelvic pain, and adenomyosis)
Being married and sexually active
Having just one partner
Being within 2 months to one year post-operation
Having access to the internet and communication tools
Not using hormonal replacement therapy (HRT)
Not receiving other educational programs
Not consuming psychiatric drugs
No history of mental illness
Absence of medical conditions (cardiac disorders, high blood pressure, respiratory diseases, thyroid disorders, epilepsy, overt diabetes)
No recent experience of stressful and unpleasant events in the past six months (serious illness of self or immediate family members, death of a loved one, accidents, severe family conflicts, divorce, migration, expulsion, unemployment, bankruptcy)
Quality of sexual life score less than 80 or marital adjustment score less than 100</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue the collaboration
Absence from more than one session
Failure to complete assignments for more than two sessions
Experiencing significant stressful events during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>(http://ap</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Z90.7Acquired absence of genital organ(s)F52.1Sexual aversion and lack of sexual enjoymentZ70.0Counselling related to sexual attitudeZ70.1Counselling related to patient's sexual behaviour and orientationZ70.8Other sex counsellingZ71.8Other specified couns</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Receive 6 online coaching sessions based on the Solution-Focused approach.</i_keyword>
      <i_keyword>Control group: It does not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in the Average Scores of Individuals on the Simon's Sexual Quality of Life Questionnaire for Women. Timepoint: At the beginning of the study, immediately and one month after the completion of the consultation sessions. Method of measurement: Simon's Sexual Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Changes in Average Marital Adjustment Scores of Spouses. Timepoint: At the beginning of the study, immediately and one month after the completion of the consultation sessions. Method of measurement: Dyadic adjustment scale.</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>2024-05-14</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing &amp; Midwifery - Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad University of Medical Sciences, Khwarazmi Complex, School of Nursing and Midwifery, 2nd Floor, Room C26 Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
