<?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>IRCT20110629006917N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-27</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of expressive writing on sexual dysfunction, quality of life and body image of women with MS</public_title>
      <acronym>MS</acronym>
      <scientific_title>The effect of expressive writing on sexual dysfunction, quality of life and body image of women with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43488</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Other design features: This study was designed as a four-group Solomon study to minimize the impact of pre-test questionnaires on attitude and subjectivity of research units. In this way we will have two intervention and two control groups and one intervention and one control group will complete pre-test and post-test questionnaires and the other two groups will answer only post-test questionnaires (Delavar, 2016). the explanation of the four groups is as follows.Control group A1: Includes those in the control group without pre-test, who will only complete the post-test questionnaires.Control group A2: Including control group who will complete the questionnaires in two stages before and after the intervention.Intervention group B1: Includes those in the intervention group without pre-test who will only complete the post-test questionnaires.Intervention group B2: Includes those in the intervention group who will complete the questionnaires in two stages before and after the intervention, Randomization description: the allocation of samples in 4 groups A1 and B1 groups without pre-test, and groups A2 and B2 groups with pre-test and post-test will determine by computer random number table. And sampling will continue until completion of sample size in each The subgroups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis (MS).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group consists of 52 married women aged 18-45 years with multiple sclerosis who will be divided into two subgroups of 26 based on Solomon's design. The first group is the intervention group without pre-test and only completes the questionnaires after the intervention. The second group will complete the questionnaires in both stages before and after the intervention. The overall six-week intervention period is designed, with participants completing assignments each week. A commitment and service contract will be provided to the participants of the intervention groups and signed prior to starting writing at home to consider performing the work as part of their duties. Finally, the research units execute the program at home on a daily basis for 6 consecutive weeks. At the core of this method of writing are two central tools of writing: morning pages and an in-person artist appointment. Morning pages are such that they will write their morning pages every morning during these 6 weeks of intervention. Generally speaking, the morning pages consist of 3 regular handwritten pages, They write freely and without thinking and do not give up on paper. There is no wrong way to write the morning pages. Even if nothing comes to mind, the three pages say "nothing comes to mind." The definition of an in-house artist meeting is that they cultivate awareness every week for a full time (eg two hours). This appointment can be the best of the kind of tour, recreation and play they can plan in advance, and will not be canceled against any interference with or obstructions. At this meeting, no one is going to bring anyone, and we will tell them that this is a chance to listen to what you are saying. They will be told that there are probably many reasons to avoid doing this and the most common is to say that I am not in good financial shape, but the artist within you is a child who spends more time with her parents than It is money only and they can only go to shops and this principle is essential for self-care. For the sake of convenience, participants will be given five thousand dollars a week to donate to an artist within themselves. There are also a number of creative assignments each week that will be performed on different days until the end of each week. At the end of each week, an assessment will be made of how the assignments will be completed by completing the checklist. Intervention 2: Control group: This group consists of 52 married women aged 18-45 years with multiple sclerosis who will be divided into two subgroups of 26 based on Solomon's design. The first group is the intervention group without pre-test and only completes the questionnaires after the intervention. The second group will complete the questionnaires in both stages before and after the intervention. The control group is routinely monitored.  After completion of the intervention group, a Justification meeting will be held for both control groups and a weekly service plan will be presented.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is "No more information".</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr Ave., above Vanak Square, Rashid Yasimi Street</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۶۷۱۳۸۸۳</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>amini.l@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr Ave., above Vanak Square, Rashid Yasimi Street</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۶۷۱۳۸۸۳</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>amini.l@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum literacy
Obtain an EDSS disability score of less than 4.5 to the physician's diagnosis
At least one year after diagnosis
Having sex at least once a month during the past month
Access to and ability to use virtual networks such as WhatsApp
Women with Multiple Sclerosis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Taking drugs that affect sexual function
use of psychotropic drugs, alcohol, opiates, hallucinogens or drugs affecting sexual desire and sexual function in couples, as reported by the patient or registered in the case
Chronic disease other than MS in research units
pregnancy or lactation
traumatic event occurring three months prior to intervention according to patient
Relationship between participants with other clients in that center or non-membership of a virtual shared group</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This group consists of 52 married women aged 18-45 years with multiple sclerosis who will be divided into two subgroups of 26 based on Solomon's design. The first group is the intervention group without pre-test and only completes the questionnaires after the intervention. The second group will complete the questionnaires in both stages before and after the intervention. The overall six-week intervention period is designed, with participants completing assignments each week. A commitment and service contract will be provided to the participants of the intervention groups and signed prior to starting writing at home to consider performing the work as part of their duties. Finally, the research units execute the program at home on a daily basis for 6 consecutive weeks. At the core of this method of writing are two central tools of writing: morning pages and an in-person artist appointment. Morning pages are such that they will write their morning pages every morning during these 6 weeks of intervention. Generally speaking, the morning pages consist of 3 regular handwritten pages, They write freely and without thinking and do not give up on paper. There is no wrong way to write the morning pages. Even if nothing comes to mind, the three pages say "nothing comes to mind." The definition of an in-house artist meeting is that they cultivate awareness every week for a full time (eg two hours). This appointment can be the best of the kind of tour, recreation and play they can plan in advance, and will not be canceled against any interference with or obstructions. At this meeting, no one is going to bring anyone, and we will tell them that this is a chance to listen to what you are saying. They will be told that there are probably many reasons to avoid doing this and the most common is to say that I am not in good financial shape, but the artist within you is a child who spends more time with her parents than It is money only and they can only go to shops and this principle is essential for self-care. For the sake of convenience, participants will be given five thousand dollars a week to donate to an artist within themselves. There are also a number of creative assignments each week that will be performed on different days until the end of each week. At the end of each week, an assessment will be made of how the assignments will be completed by completing the checklist</i_keyword>
      <i_keyword>Control group: This group consists of 52 married women aged 18-45 years with multiple sclerosis who will be divided into two subgroups of 26 based on Solomon's design. The first group is the intervention group without pre-test and only completes the questionnaires after the intervention. The second group will complete the questionnaires in both stages before and after the intervention. The control group is routinely monitored.  After completion of the intervention group, a Justification meeting will be held for both control groups and a weekly service plan will be presented.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual dysfunction. Timepoint: Before intervention and immediately after intervention, four weeks and eight weeks after intervention. Method of measurement: The Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19).</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before intervention and immediately after intervention, four weeks and eight weeks after intervention. Method of measurement: Multiple Sclerosis Quality of Life-54 (MSQOL-54).</prim_outcome>
      <prim_outcome>Body image. Timepoint: Before intervention and immediately after intervention, four weeks and eight weeks after intervention. Method of measurement: Fisher Body Image Test.</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>Iran university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-15</approval_date>
        <contact_name>iran national committee for Ethics in Biomedical Research</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town, Tehran, Iran. tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
