<?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>IRCT20181205041861N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-08</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Mobile Phone Applications Education In SCI</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mobile-based APP education on sexual  adjustment sexual satisfaction, marital adjustment and marital satisfaction of men with spinal cord injury</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40496</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Individuals were randomly assigned to two groups of Intervention and control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual adjusment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The application is designed to be installed on the smartphone of the intervention group eg ; Men with spinal cord injury and its use is explained. The intervention consists of three phases of pre-test, content training, and post-test. The app is designed to allow active training content to be immediately integrated into the intervention group after completing the pre-test form, and the group will have access to educational content for up to 8 weeks at any time and place on their mobile phone. After completing the training, the first test will be activated, and at the end of the first test, a message will be sent to the individual who will read the next 4 weeks to complete the second test. Intervention 2: Control group:  After loading and installing the application, the control group can only access the pre-test section on their mobile phone. Educational content is disabled for this group.  4 and 8 weeks after the end of the intervention, the post-test section is activated for the control group. At the end of the intervention, the control group will have access to educational content.</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:
Demographic information is confidential, but information
about the outcome of the participant's behavior is shareable.

When:
A week after receiving the request via email to the corresponding researcher

To whom:
Researchers in academic institutions

Conditions:
Deputies of health in Medical Universities

Where to obtain:
Contact with Dr.Fatemeh Zarei as the corresponding researcher via email: f.zarei@modares.ac.ir

How to obtain:
A week after receiving the request via email the corresponding researcher

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Jalal Ale Ahmad ,Nasr.Tarbiat Modares University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 4546</telephone>
        <email>f.zarei@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Jalal Ale Ahmad ,Nasr.Tarbiat Modares University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 4546</telephone>
        <email>f.zarei@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The mere man's involvement in spinal cord injury
Type of incomplete or complete traumatic spinal cord injury
Duration of damage for one year or more
Having aged over 18 years old
Ability to speak Persian,Interested in participating in the study
At least one year of life in common marriage
Not attending couples' training classes before the study
Having a minimum  level of literacy
Having a mobile phone with Android system
The age difference of couples is less than or equal to 10 years
Not having a history of infertility</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>People whose spinal cord injury is due to other diseases or non-traumatic causes.
History of or chronic psychological disorders such as depression and anxiety
History of physical problems other than spinal cord injury
Excessive brain damage leading to cognitive problems
History of drug abuse and history of using psychiatric drugs in the last six months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z70.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Counselling related to sexual attitude</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The application is designed to be installed on the smartphone of the intervention group eg ; Men with spinal cord injury and its use is explained. The intervention consists of three phases of pre-test, content training, and post-test. The app is designed to allow active training content to be immediately integrated into the intervention group after completing the pre-test form, and the group will have access to educational content for up to 8 weeks at any time and place on their mobile phone. After completing the training, the first test will be activated, and at the end of the first test, a message will be sent to the individual who will read the next 4 weeks to complete the second test.</i_keyword>
      <i_keyword>Control group:  After loading and installing the application, the control group can only access the pre-test section on their mobile phone. Educational content is disabled for this group.  4 and 8 weeks after the end of the intervention, the post-test section is activated for the control group. At the end of the intervention, the control group will have access to educational content.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual adjustment. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: Hospital Anxiety and Depression Scale(SAQ).</prim_outcome>
      <prim_outcome>Sexual Satisfaction. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: Sexual adjustment questionnaire Larson’s.</prim_outcome>
      <prim_outcome>Marital adjustment. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: Spinner’s Marital adjustment.</prim_outcome>
      <prim_outcome>Sexual-Satisfaction. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: Sexual-Satisfaction scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mean score of Sexual Adjustment. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: Via Hospital Anxiety and Depression Scale (SAQ).</sec_outcome>
      <sec_outcome>Mean score of Sexual satisfaction. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: Larson’s Sexual-Satisfaction scale.</sec_outcome>
      <sec_outcome>Mean score of Marital adjustment. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: Spinner’s’ Marital adjustment questionnaire.</sec_outcome>
      <sec_outcome>Mean score of Marital satisfaction. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: Via  Marital Satisfaction ENRICH.</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>2016-02-22</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran, Keshavarz Blvd., Ghodss St., Central Office, Tehran University of Medical Sciences, Seventh Floor, Educational Assistant Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
