<?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>IRCT20221219056866N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-15</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Sexual Health counseling based on Good Enough Sexual Model (GESM)  versus PERMA (Positive Emotion, Engagement, Positive Relationships, Meaning, Accomplishment) on Sexual Function and Quality of Sexual Life in women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Sexual Health counseling based on Good Enough Sexual Model (GESM)  versus PERMA (Positive Emotion, Engagement, Positive Relationships, Meaning, Accomplishment) on Sexual Function and Quality of Sexual Life in women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>82</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67640</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling in this research will be done by simple random allocation method. so that the second author (student) gave each woman a number from 1 to 82 based on the entry and exit criteria, and using random allocation software, the women were divided into two groups based on the randomization method (A: sexual experience model) Good enough and B: Perma model or positivism approach) are divided. At the beginning of the study, people are told that they have the same chance to be in each intervention group. So that except for the biostatistics researcher, no one (not the students, supervisors and advisors, nor the participants) knows in which group they will be allocatedEach group is divided into three sub-blocks. So that 41 participants in each intervention group are invited to 3 sub-groups (two groups of 14 people and one group of 13 people) for face-to-face counseling.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Sexual dysfunction counseling. Condition 2: Counseling the quality of sexual life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The intervention in the group of good enough sexual experience model is done face-to-face and in a group at Bandar Abbas Comprehensive Health Center for 4 sessions of 90 minutes, once a week by the second researcher under the supervision of the first and third researchers. The content of the sessions includes explaining the importance of sex as a vital element of life, the importance of the quality of sex and sexual satisfaction in the sexual development of couples, setting realistic expectations for sex, emphasizing physical health and healthy habits to restore sexual healthBehavioral education and counseling, paying attention to getting sexual pleasure as much as achieving proper sexual performance, counseling to overcome sexual fears and worries, training to have unusual sexual experiences, put aside idealistic ideas about sex, setting goals in Sex, getting to know the styles of sexual arousal, getting to know gender differences and accepting similarities and differences, strengthening communication skills, training the sexual desire cycle and counseling for personalizing sexual desire. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed and the assigned tasks related to the previous session will be reviewed by the researcher. Women are asked to participate in discussions and raise their questions. At the end of each session, a summary of the important topics discussed is presented and people's questions are answered, and women are asked to do their homework in the next sessions. Intervention 2: Intervention group:The intervention in the positivism approach group is conducted face-to-face and as a group in the hall of Bandar Abbas Comprehensive Health Center for 5 sessions of 90 minutes, once a week by the second researcher under the supervision of the first and third researchers. The content of the sessions includes positive emotions, engagement, positive relationship, meaning and achievement. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed and the assigned tasks related to the previous session will be reviewed by the researcher. Women are asked to participate in discussions and raise their questions. At the end of each session, a summary of the important topics discussed is presented and people's questions are answered, and women are asked to do their homework in the next sessions.</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>Bouali ave</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>Bouali ave</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>Women of reproductive age (15-49 years)
Women living in Bandar Abbas city and having health records in comprehensive health centers
Being Iranian
Being married
Being the only spouse
Having a common platform
Having at least reading and writing literacy
Obtaining a score of less than 28 in the Rozen Women's Sexual Performance Index Questionnaire
Interested in participating in studying and doing homework</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
Breastfeeding
Sterility
Psychiatric diagnosis of depression and anxiety
Lack of medical history for chronic diseases
Addiction to alcohol or drugs in oneself or one's spouse according to the woman's statement
Simultaneous participation in educational sessions or sexual counseling</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z70</hc_code>
      <hc_code>Z70</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Counseling related to sexual attitude, behavior and orientation</hc_keyword>
      <hc_keyword>Counseling related to sexual attitude, behavior and orientation</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 intervention in the group of good enough sexual experience model is done face-to-face and in a group at Bandar Abbas Comprehensive Health Center for 4 sessions of 90 minutes, once a week by the second researcher under the supervision of the first and third researchers. The content of the sessions includes explaining the importance of sex as a vital element of life, the importance of the quality of sex and sexual satisfaction in the sexual development of couples, setting realistic expectations for sex, emphasizing physical health and healthy habits to restore sexual healthBehavioral education and counseling, paying attention to getting sexual pleasure as much as achieving proper sexual performance, counseling to overcome sexual fears and worries, training to have unusual sexual experiences, put aside idealistic ideas about sex, setting goals in Sex, getting to know the styles of sexual arousal, getting to know gender differences and accepting similarities and differences, strengthening communication skills, training the sexual desire cycle and counseling for personalizing sexual desire. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed and the assigned tasks related to the previous session will be reviewed by the researcher. Women are asked to participate in discussions and raise their questions. At the end of each session, a summary of the important topics discussed is presented and people's questions are answered, and women are asked to do their homework in the next sessions.</i_keyword>
      <i_keyword>Intervention group:The intervention in the positivism approach group is conducted face-to-face and as a group in the hall of Bandar Abbas Comprehensive Health Center for 5 sessions of 90 minutes, once a week by the second researcher under the supervision of the first and third researchers. The content of the sessions includes positive emotions, engagement, positive relationship, meaning and achievement. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed and the assigned tasks related to the previous session will be reviewed by the researcher. Women are asked to participate in discussions and raise their questions. At the end of each session, a summary of the important topics discussed is presented and people's questions are answered, and women are asked to do their homework in the next sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in mean scores of sexual performance in women. Timepoint: In the baseline, completion of the intervention (week 4 in the good enough sexual experience model and week 5 in the positivism approach) and in the follow-up period (4 weeks after the completion of the intervention) in each group. Method of measurement: FSFI-female sexual function index (Rosen et al.).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change in the mean scores of women's sexual life quality. Timepoint: In the baseline, completion of the intervention (week 4 in the good enough sexual experience model and week 5 in the positivism approach) and in the follow-up period (4 weeks after the completion of the intervention) in each group. Method of measurement: SQOL-F Sexual Life Quality Questionnaire (Simonds et al.).</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>2022-11-16</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Bahonar Square; Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
