<?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>IRCT20201015049031N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-23</date_registration>
      <primary_sponsor>Tarbiat Modares University of Tehran</primary_sponsor>
      <public_title>Design and effectiveness of a sexual satisfaction promotion program</public_title>
      <acronym></acronym>
      <scientific_title>Design and effectiveness of sexual satisfaction promotion program in married men: based on Information, Motivation and Behavioral skills model.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52783</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A simple randomization method is used. They are individual randomization units and are assigned to one of the intervention and control groups using a table of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual dissatisfaction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: An educational package entitled "Sexual Satisfaction Promotion" was prepared for the intervention group and its content was used as a digital booklet, multimedia PowerPoint and SMS in the WhatsApp virtual group, for 3 months, respectively, lesson plan training sessions with questions and Answers and group discussions are posted. Intervention 2: Control group: The control group completes the pre-test questionnaire and will not receive any intervention, and after three months, will complete the same questionnaire as the post-test.</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:
Data on study outcomes can be shared after non-identifying individuals.

When:
Access period starts 8 months after the results are published

To whom:
Students, researchers and staff at scientific centers are allowed access to the data upon request.

Conditions:
The use of data is allowed with the permission of the ethics committee of Tarbiat Modares University of Tehran.

Where to obtain:
Submit an application by email to the principal investigator at naseh_1366@yahoo.com

How to obtain:
Submitting a request via email to the main researcher, sending a request to the ethics committee of Tarbiat Modares University of Tehran for review, if approved and allowed, the ethics committee of the data university will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fazlollah Ghofranipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al-Ahmad St., Nasr Bridge</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111-14115</zip>
        <telephone>+98 21 8288 3869</telephone>
        <email>ghofranf@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University, Tehran, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fazlollah Ghofranipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3869</telephone>
        <email>ghofranf@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University, Tehran, Iran.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>6 months to 5 years have passed since the beginning of their married life.
Be over 18 years old and have no age difference of more than 15 years and their age should not be more than 50 years.
Have at least a basic education and the ability to read and write.
Formal marriage and monogamy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></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>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: An educational package entitled "Sexual Satisfaction Promotion" was prepared for the intervention group and its content was used as a digital booklet, multimedia PowerPoint and SMS in the WhatsApp virtual group, for 3 months, respectively, lesson plan training sessions with questions and Answers and group discussions are posted.</i_keyword>
      <i_keyword>Control group: The control group completes the pre-test questionnaire and will not receive any intervention, and after three months, will complete the same questionnaire as the post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual information. Timepoint: Before and 3 months after the intervention. Method of measurement: Questionnaire on sexual information, motivation and behavioral skills.</prim_outcome>
      <prim_outcome>Sexual motivation. Timepoint: Before and 3 months after the intervention. Method of measurement: Questionnaire on sexual information, motivation and behavioral skills.</prim_outcome>
      <prim_outcome>Behavioral skills. Timepoint: Before and 3 months after the intervention. Method of measurement: Questionnaire on sexual information, motivation and behavioral skills.</prim_outcome>
      <prim_outcome>Self-efficacy. Timepoint: Before and 3 months after the intervention. Method of measurement: Questionnaire on sexual information, motivation and behavioral skills.</prim_outcome>
      <prim_outcome>Behavior. Timepoint: Before and 3 months after the intervention. Method of measurement: Questionnaire on sexual information, motivation and behavioral skills.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual satisfaction. Timepoint: Before and 3 months after the intervention. Method of measurement: Larson Sexual Satisfaction Questionnaire.</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>Tarbiat Modares University, Tehran, Iran.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-07</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modares University of Tehran</contact_name>
        <contact_address>Jalal Al-Ahmad, Nasr Bridge Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
