<?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>IRCT20230209057373N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-19</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of online and face to face  positive psychology counseling on sexual intimacy in women undergoing hysterectomy due to benign reasons.</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of online and face to face  positive psychology counseling on sexual intimacy in women undergoing hysterectomy due to benign reasons.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68652</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 66 women with a history of hysterectomy have a record of hospitalization in Shohadaye Kargar Hospital of Yazd and are included in the study based on the entry and exit criteria.Sampling in this research will be done by simple random allocation method.So that by the expert of biostatistics using simple randomization method and sequence of random numbers with random allocation software, these women are divided into two groups of 33 people: virtual positive counseling (intervention group) and face-to-face positive counseling (control group). At the beginning of the study, people are told that they have the same chance to be in each intervention group. And except for the biostatistics researcher, no one (not the students, supervisors and advisors and not the participants) knows in which group they will be allocated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual intimacy counseling.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The virtual counseling group is subjected to the protocol of counseling and question and answer during 8 counseling sessions for 90 minutes, a positive approach in sexual relations where both the content of the sessions are presented and the questions are answered. Counseling by a researcher who is studying counseling in midwifery and has obtained the certificate of ability to complete the positive-oriented approach counseling course under the supervision of supervisors, the counselor is implemented. In the intervention group, there are 8 virtual group counseling sessions of 90 minutes, the content of the positive-oriented approach sessions with The subject of the effect of a positive cognitive approach on sexual satisfaction and marital compatibility, which has been approved by supervisors, advisors, referees, and supervisors, is prepared in a multimedia format and one day a week in a virtual way by installing one of the software The authorized messengers are carried out on mobile phones of the research units and they are asked to ask their questions in the form of online chat and receive the necessary advice and guidance from the researcher. Intervention 2: Control group: the face-to-face intervention or control group, the content of the sessions is the same as the virtual intervention group, with the difference that one session per week is held as a group according to the planning between the researcher and the clients by the researcher at Shohada Karegar Hospital. In the control group, there were 8 face-to-face group counseling sessions, 90 minutes, with the content of the positive approach sessions on the topic of the effect of the positive cognitive approach on sexual satisfaction and marital adjustment by a researcher who studies counseling in midwifery and a certificate of ability to complete the positive approach counseling course. It is implemented under the supervision of supervisors and advisors.</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:
All individual data of study participants can be shared after de-identification.

When:
After results publication.

To whom:
The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them

Conditions:
Scientific usage.

Where to obtain:
mah_bokaie@yahoo.com

How to obtain:
One week after receiving the applicant's email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahshid Bokaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Midwifery Nursing., Bouali Alley., Teymsar Fallahi St., Safaieh., Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>mah_bokaie@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahshid Bokaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Midwifery Nursing., Bouali Alley., Teymsar Fallahi St., Safaieh., Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>mah_bokaie@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20 and 60 years
The cause of hysterectomy is benign
The type of hysterectomy should be complete abdominal
Three months to two years have passed since the hysterectomy.
Have a common bed with her husband
Be the only wife of her husband
Have access to a smart phone and the Internet.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participation in psychological and psychiatric interventions at the same time
taking psychiatric drugs (according to the patient).
Have done a vaginal hysterectomy.
She or her husband have addiction (according to the patient)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z70.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other sex counselling</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: The virtual counseling group is subjected to the protocol of counseling and question and answer during 8 counseling sessions for 90 minutes, a positive approach in sexual relations where both the content of the sessions are presented and the questions are answered. Counseling by a researcher who is studying counseling in midwifery and has obtained the certificate of ability to complete the positive-oriented approach counseling course under the supervision of supervisors, the counselor is implemented. In the intervention group, there are 8 virtual group counseling sessions of 90 minutes, the content of the positive-oriented approach sessions with The subject of the effect of a positive cognitive approach on sexual satisfaction and marital compatibility, which has been approved by supervisors, advisors, referees, and supervisors, is prepared in a multimedia format and one day a week in a virtual way by installing one of the software The authorized messengers are carried out on mobile phones of the research units and they are asked to ask their questions in the form of online chat and receive the necessary advice and guidance from the researcher.</i_keyword>
      <i_keyword>Control group: the face-to-face intervention or control group, the content of the sessions is the same as the virtual intervention group, with the difference that one session per week is held as a group according to the planning between the researcher and the clients by the researcher at Shohada Karegar Hospital. In the control group, there were 8 face-to-face group counseling sessions, 90 minutes, with the content of the positive approach sessions on the topic of the effect of the positive cognitive approach on sexual satisfaction and marital adjustment by a researcher who studies counseling in midwifery and a certificate of ability to complete the positive approach counseling course. It is implemented under the supervision of supervisors and advisors.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in mean scores of sexual intimacy in women. Timepoint: Measuring the sexual intimacy score at the beginning of the study (before the start of the intervention) and 8 and 12 weeks after the start of virtual and face-to-face counseling. Method of measurement: Women's Sexual Intimacy Questionnaire (Botlani et al.).</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-24</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Bld., Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
