<?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>IRCT20200620047846N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-01</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of solution focused therapy consoling in marital intimacy of women suffering from Down syndrome child</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of solution- focused therapy counseling with educational pamphlets on improving marital intimacy of women suffering from Down syndrome child</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49041</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sample size consists of 72 people (women) and due to the fact that counseling sessions are held in the presence of women and online, each person can be assigned a number between 1 and 72, which can be found by visiting the site. Random allocation is done online. There are currently three models of random allocation, and considering that this study is in two groups (intervention and control group), the first generation randomization model is used, where each sample (female) is placed in a treatment group. This is called block randomization and is done through the site. Http://www.randomization.com. Through the blocks on the site, groups A and B are entered in the treatment groups section, and then the number of people, which is 72, is entered in the number of people in the treatment blocks, where the software of each person is entered. Assigns to one of the two groups A and B randomly, which means that the assignment of individuals to each of the two groups does not occur in the order AB, but in the order in which the software output is placed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Marital intimacy in mothers with children with Down syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Counseling for the experimental group is done in 8 sessions of 90 minutes once a week and online and doing homework. In the first session, the questionnaire is completed online by the couple separately, which takes 10 minutes. Then, the contents of the first session: the anatomy of the female reproductive system, creating communication and acquaintance, familiarizing the participants with the goals, rules and work process of the sessions, creating hope for change in the participants, asking for their expectations, giving homework, are expressed. In each session, the first 15 minutes of homework review, 45 minutes of content of the same session and 30 minutes of questions and answers. The contents of the second session: review of homework, familiarity with the basic principles of solution-oriented counseling and its application, review of active acceptance of responsibility in a relationship, formulation of problem-solving circles. Session 3: Reviewing assignments, identifying participants' solutions to different problem areas, familiarizing participants with useful solutions and repeating them, and discarding inappropriate solutions, finding a positive story. Session 4: Assignment of tasks, commitment and hope of participants to solve the problem, identify and solve the resistance of participants, talk about the future, talk about tasks, use the technique of scale questions. Session 5: Reviewing assignments, familiarizing members with problem exceptions, strengthening and highlighting problem exceptions, participants realizing their capabilities and capabilities. Session 6: Assessment of assignments, helping participants to identify other ways of thinking, feeling and behaving instead of thinking, feeling and behaving the current problem, helping participants to admire instead of criticizing each other, performing the master key technique. Session 7: Review assignments, help participants imagine a future of interest and a better world, help participants get out of trouble and identify. Session 8: Summarizing the sessions and concluding, using the graded questions, conducting the post-test, thanking and appreciating the members for participating in the meeting. Intervention 2: Control group: The control group will be given an educational pamphlet during 4 sessions، every other week, during the consultation of the intervention group, without doing homework.</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:
The results of the clinical study will be published in the form of an article.

When:
Immediately after printing the results

To whom:
All researchers

Conditions:
Scientific use with reference to the article

Where to obtain:
Email: naeime.mir61@gmail.com

How to obtain:
Up to one week after correspondence by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naeime Mirshafieian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 115, Madain Alley, Lahore St., Isfahan</address>
        <city>Sfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8157796360</zip>
        <telephone>+98 31 3274 3257</telephone>
        <email>naeime.mir61@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahshid Bokaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safaieh, Timsar Fallahi St., Bouali Sina Alley, School of Midwifery and Nursing</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</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>The desire to participate the study
Having a smart phone
Being Iranian
Living in Isfahan
Reading and Writing literacy
Married and with a spouse
Being one`s only spouse
Down`s age over 2 years
Member of Isfahan Sky Blue Association
Having an infected child</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Alcohol and drug addiction in oneself or one's spouse, according to the person, use of drugs affecting sexual function such as psychiatric drugs in oneself or one's spouse, diseases affecting sexual function such as diabetes, applicant for other help such as psychological services, Simultaneous participation in other treatment programs</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Counseling for the experimental group is done in 8 sessions of 90 minutes once a week and online and doing homework. In the first session, the questionnaire is completed online by the couple separately, which takes 10 minutes. Then, the contents of the first session: the anatomy of the female reproductive system, creating communication and acquaintance, familiarizing the participants with the goals, rules and work process of the sessions, creating hope for change in the participants, asking for their expectations, giving homework, are expressed. In each session, the first 15 minutes of homework review, 45 minutes of content of the same session and 30 minutes of questions and answers. The contents of the second session: review of homework, familiarity with the basic principles of solution-oriented counseling and its application, review of active acceptance of responsibility in a relationship, formulation of problem-solving circles. Session 3: Reviewing assignments, identifying participants' solutions to different problem areas, familiarizing participants with useful solutions and repeating them, and discarding inappropriate solutions, finding a positive story. Session 4: Assignment of tasks, commitment and hope of participants to solve the problem, identify and solve the resistance of participants, talk about the future, talk about tasks, use the technique of scale questions. Session 5: Reviewing assignments, familiarizing members with problem exceptions, strengthening and highlighting problem exceptions, participants realizing their capabilities and capabilities. Session 6: Assessment of assignments, helping participants to identify other ways of thinking, feeling and behaving instead of thinking, feeling and behaving the current problem, helping participants to admire instead of criticizing each other, performing the master key technique. Session 7: Review assignments, help participants imagine a future of interest and a better world, help participants get out of trouble and identify. Session 8: Summarizing the sessions and concluding, using the graded questions, conducting the post-test, thanking and appreciating the members for participating in the meeting.</i_keyword>
      <i_keyword>Control group: The control group will be given an educational pamphlet during 4 sessions، every other week, during the consultation of the intervention group, without doing homework.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intimacy score in Bagarozi Marital Intimacy Questionnaire. Timepoint: Intimacy score before, immediately and one month after the intervention. Method of measurement: Bagarozi Marital Intimacy Questionnaire.</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>2020-09-08</approval_date>
        <contact_name>Research Ethics committee of Yazd University of Medical Sciences</contact_name>
        <contact_address>Yazd - Safaieh - Timsar Fallahi St. - Bouali Sina Alley - School of Nursing and Midwifery Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
