<?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>IRCT20160808029255N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Remote Group intervention on sexual health literacy, sexual function, sexual self-efficacy and quality of sexual life of women in reproductive age</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Remote Group intervention on sexual health literacy, sexual function, sexual self-efficacy and quality of sexual life of women in reproductive age:A randomized clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52822</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, randomization method will be randomized block design with block size of 4. The block randomization method is designed to randomize participants into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. in this clinical trial with control and treatment groups, a randomized block procedure would be as follows: (1) a block size of 4 will be chosen, (2) possible balanced combinations with 2 A (intervention) and 2 B (control) subjects will be calculated as 6 (BBAA, BABA, BAAB, ABBA, ABAB, AABB) and (3) blocks will be randomly chosen to determine the assignment of all participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: sexual health literacy. Condition 2: sexual function. Condition 3: Quality of sexual life. Condition 4: Sexual self-efficacy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group,  will have access to the Content of the intervention as offline mode weekly for 8 weeks, and during this time, in online and offline peer's Whatsapp group, the content of the intervention will be analyzed Weekly by researcher for further training and the asked questions of individuals will be solved in the group  .Standard questionnaires will be complete before and immediately after 8 sessions of intervention and also  one month after the intervention. Intervention 2: Control group: The control group will  receive information about Covid-19 until the end of the research. Then, based on the ethics of the research and their willingness can use the content of Intervention.Standard questionnaires will be complete before and immediately after 8 sessions of intervention and also to one month after the intervention in control group.</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 of the study would be available after unrecognizable process of participants.

When:
6 months after publications of findings

To whom:
Data of this research would be available for academic researchers

Conditions:
Data of this study would be available for same research

Where to obtain:
Dr. Raziyeh Maasoumi email: r_masoumi@sina.tums.ac.ir

How to obtain:
Sending a request by email attendance to the office of corresponding of project presentation the reasons for similarity of two projects studying the proposal by corresponding of project final decision making with corresponding author access of data in office of corresponding author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Raziyeh Maasoumi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East Nosrath., Towhid Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4214</telephone>
        <email>r_masoumi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Raziyeh Maasoumi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East Nosrath., Towhid Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4214</telephone>
        <email>r_masoumi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian originality
reading and writing literacy
marriage
Not having physical or mental diseases affecting sexual health of the woman or her husband
Not having critical marital conflicts or not being on the verge of divorce
Not previous participation in Sex education classes
Willingness to attend all meetings
At least one year of living together
Not infection to Known sexual dysfunction like Vaginismus
not being pregnant and Menopause
Do not consume of Cigarettes, Alcohol and no addiction in woman or her husband
Do not take any Psychotropic or psychoactive drug or Drugs affecting the sexual response cycle during intervention by woman or her husbandHaving
having a mobile phone with Android system
Access to internet</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>exclution criteria: Unwillingness of the women to continue participating in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_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>Intervention group: The intervention group,  will have access to the Content of the intervention as offline mode weekly for 8 weeks, and during this time, in online and offline peer's Whatsapp group, the content of the intervention will be analyzed Weekly by researcher for further training and the asked questions of individuals will be solved in the group  .Standard questionnaires will be complete before and immediately after 8 sessions of intervention and also  one month after the intervention.</i_keyword>
      <i_keyword>Control group: The control group will  receive information about Covid-19 until the end of the research. Then, based on the ethics of the research and their willingness can use the content of Intervention.Standard questionnaires will be complete before and immediately after 8 sessions of intervention and also to one month after the intervention in control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual health literacy. Timepoint: Before the intervention, immediately and one month after the intervention. Method of measurement: Iranian Adult Sexual Health Literacy Standard Questionnaire.</prim_outcome>
      <prim_outcome>Sexual function. Timepoint: Before the intervention, immediately and one month after the intervention. Method of measurement: The standardized Persian version of the six-item women's sexual function index.</prim_outcome>
      <prim_outcome>Quality of sexual life. Timepoint: Before the intervention, immediately and one month after the intervention. Method of measurement: Standardized questionnaire Quality of sexual life for Iranian women.</prim_outcome>
      <prim_outcome>Sexual self-efficacy. Timepoint: Before the intervention, immediately and one month after the intervention. Method of measurement: Standardized questionnaire of sexual self-efficacy for Iranian women.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-08</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>East Nosrath., Towhid Sq Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
