<?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>IRCT20151208025431N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-11</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Intervention on Increasing the empowerment health care in married women</public_title>
      <acronym></acronym>
      <scientific_title>Effect of an intervention on health care empowerment among women in reproductive age referring to health centers affiliated to Tehran University of Medical Sciences: Application of the Theory of Planned Behavior</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>484</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32603</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Empowerment to receive health care in women of reproductive age.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Educational interventions to increase the empowerment to receive health care in married women of reproductive age (aged 15-49) with the application of the theory of planned behavior and the needs assessment that was done prior to the beginning of the study and the empowerment to receive health care in women of reproductive age before The intervention will be measured 6 months after the intervention. Intervention 2: Control group: In the control group, intervention is not performed and only after completing the study for observance of the ethics of all the teaching aids will be provided to this 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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Saboury</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences, Enqelab St, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417613151</zip>
        <telephone>+98 77624517</telephone>
        <email>msaboury@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Elham Shakibazeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health, Poursina Street, Quds Ave, Keshavarz Boulevard, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417613151</zip>
        <telephone>+98 21 4293 3333</telephone>
        <email>shakibazadeh@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married women referring to health centers in the south
At the age of fertility (age 49-15)
Satisfaction to participate in the study
Women who are literate read and write
Their nationality is Iranian.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The unwillingness of the subjects under study to continue cooperation
Absence of more than 2 sessions in the training sessions, with 5 sessions for the intervention group.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z76.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Health supervision and care of foundling</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: Educational interventions to increase the empowerment to receive health care in married women of reproductive age (aged 15-49) with the application of the theory of planned behavior and the needs assessment that was done prior to the beginning of the study and the empowerment to receive health care in women of reproductive age before The intervention will be measured 6 months after the intervention.</i_keyword>
      <i_keyword>Control group: In the control group, intervention is not performed and only after completing the study for observance of the ethics of all the teaching aids will be provided to this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Behavioral intention. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Attitude towards the behavior. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Behavioral beliefs. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Outcom evaluation. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Subjective norm. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Normative beliefs. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Motivation to comply. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Perceived behavioral control. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Control Beliefs. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Perceived Power. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Empowerment health care in two dimensions: feeling and importance. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Standard (Health Care Empowerment Questionnaire).</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>2018-05-09</approval_date>
        <contact_name>Ethics committee of tehran University of Medical Sciences</contact_name>
        <contact_address>Poursina Street, Quds Ave, Keshavarz Boulevard, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
