<?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>IRCT20220217054048N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-29</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of Intimate Relationship skills versus the Training in marriage Enrichment on marital intimacy.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison survey the effectiveness  of online counseling the Practical Application of Intimate Relationship Skills (PAIRS) versus the Training in marriage Enrichment (TIME) on  marital intimacy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62010</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The specified sample size includes 88 people (women). The participants are randomized in two groups using the permuted block randomization method by the use of the software “Random Allocation” version 1, https://random-allocation-software.software.informer.com/1.0/. Considering the sample size (88 people) and also the similar size of blocks (due to having two intervention groups of A and B, the size of the block is 2 by the power of 4 which is 16) the software calculated the number of blocks to be 6.
Randomization is done in this way: women who have mentioned marital intimacy problems both in the initial interview and on the Bagarozzi questionnaire get a number from 1 to 88 according to the order of their attendance. Then, from among the 6 blocks, one block is chosen randomly which contains the name of the intervention group according to the patient’s code; therefore, each participant is randomly allocated to one of the intervention groups. After the completion of the first block, the second block is chosen randomly and the process of randomization continues. Also, since the randomization of participant in two intervention groups is carried out separately in each of the Comprehensive Healthcare Centers, two blocks are randomly allocated to each center and participants are divided into intervention group based on their numbers in the chosen blocks in each center.
Blinding is not possible since women are aware of the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Marital intimacy counseling.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group A receives the online program of the Practical Application of Intimate Relationship Skills (PAIRS) which includes these sessions: trust therapy, the importance of communication, personal history, bonding, clarification of mental imagery, clarification of expectations and days of love, adaptation to family functioning, summarizing and conclusion. Intervention is carried out in 8 sessions of 90 minutes each. The contents of online sessions in Skyroom are presented in the form of text, graphics, videos, clips, group chats and questions and answers. In every session, homework is presented and corrected via WhatsApp application by the second author under the supervision of the first and the third authors. Participants are provided with free weekly internet packages. Intervention 2: The intervention group B receives the online program of Training in Marriage Enrichment (TIME) which include these sessions: responsibility, encouragement, preferences and values, effective communication skills, choices, conflict resolution, application of conflict resolution skills, and equal marital bonding. Intervention is carried out in 8 sessions of 90 minutes each. The contents of online sessions in Skyroom are presented in the form of text, graphics, videos, clips, group chats and questions and answers. In every session, homework is presented and corrected via WhatsApp application by the second author under the supervision of the first and the third authors. Participants are provided with free weekly internet packages.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Shiravan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>14/3 alley, Shahid Khoshbakht street, Bidaleh neighborhood</address>
        <city>Gerash</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7441946655</zip>
        <telephone>+98 71 5245 1335</telephone>
        <email>l.shiravan@stu.ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>leila shiravan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>14/3 alley, Shahid Khoshbakht street, Bidleh neighborhood</address>
        <city>Gerash</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7441946655</zip>
        <telephone>+98 71 5245 1335</telephone>
        <email>l.shiravan@stu.ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian nationality
Married women between the ages of 15 and 49 who had mentioned marital intimacy problems both in the initial interview and on the Bagarozzi questionnaire.
Fluency in Persian language
Internet literacy and owning a smartphone
Having lived together for at least one year
Having a sexual relationship with husband
Being Interested in participating in training courses and attending the training sessions
Consent of both partners to participate in the study; completing the Marital Intimacy Questionnaire.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
women who have, or their husbands have, acute psychological and personality disorders, or a history of substance abuse and tobacco use
Having systemic diseases</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group A receives the online program of the Practical Application of Intimate Relationship Skills (PAIRS) which includes these sessions: trust therapy, the importance of communication, personal history, bonding, clarification of mental imagery, clarification of expectations and days of love, adaptation to family functioning, summarizing and conclusion. Intervention is carried out in 8 sessions of 90 minutes each. The contents of online sessions in Skyroom are presented in the form of text, graphics, videos, clips, group chats and questions and answers. In every session, homework is presented and corrected via WhatsApp application by the second author under the supervision of the first and the third authors. Participants are provided with free weekly internet packages.</i_keyword>
      <i_keyword>The intervention group B receives the online program of Training in Marriage Enrichment (TIME) which include these sessions: responsibility, encouragement, preferences and values, effective communication skills, choices, conflict resolution, application of conflict resolution skills, and equal marital bonding. Intervention is carried out in 8 sessions of 90 minutes each. The contents of online sessions in Skyroom are presented in the form of text, graphics, videos, clips, group chats and questions and answers. In every session, homework is presented and corrected via WhatsApp application by the second author under the supervision of the first and the third authors. Participants are provided with free weekly internet packages.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring the average scores of intimacy in women and their husbands. Timepoint: At baseline, the completion of intervention in week 8, and follow-up of the study in week 12. Method of measurement: Bagarozzi 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>2022-01-26</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>College of Nursing and Midwifery, Bo Ali Sina alley, Timsar Fallahi street,  Safaieh neighborhood Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
