<?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>IRCT20090522001930N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-14</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Life Skills Training Based on Self-Efficacy Theory on Reducing Domestic Violence and Treatment Adherence in Women with Type-2 Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of life skills training on reducing domestic violence and adherence to treatment in women with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64846</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: Does not have, Randomization description: According to block randomization the research sample will be placed into one of the two groups of intervention and control group. The number of required blocks will be selected randomly. For blocking, 12 blocks of block size of 8 and one block of block size of 4 will be used. In the first step, blocks size 8 are prepared using A (intervention) and B (control group), which will have 70 different modes. Of the blocks, 12 will be randomly selected. By selecting each block size of 8, each one will be placed in one of two groups according to the order of the letters. Each block will receive four chances for each group. Block size 4 will also be provided (6 modes) and one block will be randomly selected. With this block will receive two chances for each groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Type 2 diabetes. Condition 2: Non-adherence to treatment. Condition 3: Domestic violence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Life skills training based on self-efficacy theory will be done in the intervention group.8 sections of 120 minutes twice per week for one month؛ The method of Presentation content will be a workshop. Intervention 2: Control group: At the same time, except completing the questionnaires, no intervention will be done in the 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>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 There is no program for its release</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hakime Vahedparast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nursing, Faculty of Nursing and Midwifery, Bushehr University of Medical Sciences</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>h.vahedparast@bpums.ac.ir</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hakime Vahdeparast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nursing, Faculty of Nursing and Midwifery, Bushehr University of Medical Sciences</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>h.vahedparast@bpums.ac.ir</email>
        <affiliation>Boushehr 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>Be married and have a life with a spouse.
Suffering from type 2 diabetes diagnosed by a specialist doctor or being treated with medication
Subject to domestic violence and has received at least 60 points from the domestic violence questionnaire
At least 6 months have passed since contracting the disease
Have full listening and speaking ability.
At least have the ability to read and write
patients must be over 30 years old and up to 70 years old
Having consent to enter the study</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>She has participated in the life skills class
Have relevant education in the field of psychology and counseling
Suffering from neuropsychiatric disorders (according to self-report)
Suffering from a debilitating physical illness
Despite the explanation, the researcher did not understand the questions of the questionnaire
Suffering from a chronic disease that requires special care</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
      <hc_code>Z91. 1</hc_code>
      <hc_code>T74. 1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitusstable</hc_keyword>
      <hc_keyword>noncompliance with medical treatment and regimen</hc_keyword>
      <hc_keyword>maltreatment (physical abuse) by spouse</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Life skills training based on self-efficacy theory will be done in the intervention group.8 sections of 120 minutes twice per week for one month؛ The method of Presentation content will be a workshop.</i_keyword>
      <i_keyword>Control group: At the same time, except completing the questionnaires, no intervention will be done in the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Domestic violence. Timepoint: pre- test before the intervention and immediately after the test and 4 weeks(following) after the intervention. Method of measurement: The spousal abuse section of the domestic violence questionnaire of Mohseni Tabrizi et al، including 26 items in 4 fields؛(psychological-economical-physical-sexual).scoring is from 26  up to 130.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Treatment adherence. Timepoint: pre- test before the intervention and immediately after the test and 4 weeks(following) after the intervention. Method of measurement: Summary questionnaire of  diabetes self-caring  behaviors Tobert et al، including 12 items in five fields(diet, physical activity, self-monitoring of blood sugar, foot care and medication)، scoring is from 0  up to 84.</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>Bushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-01</approval_date>
        <contact_name>Ethics Committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>Pardis Site of Bushehr University of Medical of Science, Rishehr St, Bushehr, Iran. Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
