<?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>IRCT20171103037191N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-02</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of leventhal's self-regulatory theory on illness perception of women with gestational diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of leventhal's self-regulatory theory on illness perception of women with gestational diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34358</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In the first step, 80 samples were selected according to the Inclusion criteria. In the next step, these patients were assigned into two groups (intervention and control) by adopting 4-way blocking method. Each group consisted of 40 samples. By  assigning cards to 6 blocks possible with numbers 1-6 and placed in the container, then by selecting 20 cards from 6 cards (block), the appropriation could be done as follows.The sequence was continued until sample 80 was reached.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gestational Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention based on the illness perception individually (face to face training) will be performed in 3 sessions of 60-90 minutes in 3 consecutive days in the morning shift. In the first session, after the initial communication with the patient and asking questions about his illness perception and its consequences, the content will be presented. This session is based on five dimensions of illness  perception and the impact of illness  perception psychological outcomes. These dimensions include the nature of the disease (illness symptoms, such as fatigue, weakness); the cause of the onset of the disease; the duration or perception of the person during the illness; the outcomes of the person expected from the disease; the effectiveness of control, treatment and improvement of the disease. To interfere with the illness perception, self-control techniques, verbal encouragement, goal design (such as reducing dietary sugar), feedback and behavioral assessment, and the use of experiences from successful disease patients will be used.In the second session, after reviewing the sessions, the patient will be asked to talk about the emotions and ambiguities of her illness. The unique interventions will be adjusted according to the patient's need. Training will be designed to change the misconception and negative perception of the disease.Patients will be told if they have left a question beforehand, they can ask the researcher. In the third session (evaluation and termination), the patient will be notified of the appointment before the end of the session. First, review the training of the previous sessions, and then ask the patient about the effects of new training and experiences. Problems and barriers will be investigated for each patient. At the end of the third session, an educational booklet containing of items such as: diagnosis and definition of the diseases, points that must be observed in the diet, exercising and playing sports and also a short explanation of the laboratory finding, prepared and planned by the researcher,is given to the patient. Intervention 2: Control group: In the control group, no intervention was performed by the researcher and patients received only routine hospital care.</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 Because the participant's data file is completely confidential.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasim Bahrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Shahid Bahonar Blvd</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>34197-59811</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>nbahrami@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasim Bahrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Shahid Bahonar Blvd</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>34197-59811</zip>
        <telephone>+98 2833336001_5</telephone>
        <email>nbahrami@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a willingness to participate in the research
Definitive diagnosis of diabetes by routine screening tests during the weeks 24 to 28 of pregnancy
The ability to speak and understand Persian
Lack of chronic disease other than gestational diabetes
Not having known and diagnosed mental illness based on self-declaration
Not having a history of gestational diabetes during the previous pregnancy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Any complications in mother and fetus</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24.41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gestational diabetes mellitus in pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention based on the illness perception individually (face to face training) will be performed in 3 sessions of 60-90 minutes in 3 consecutive days in the morning shift. In the first session, after the initial communication with the patient and asking questions about his illness perception and its consequences, the content will be presented. This session is based on five dimensions of illness  perception and the impact of illness  perception psychological outcomes. These dimensions include the nature of the disease (illness symptoms, such as fatigue, weakness); the cause of the onset of the disease; the duration or perception of the person during the illness; the outcomes of the person expected from the disease; the effectiveness of control, treatment and improvement of the disease. To interfere with the illness perception, self-control techniques, verbal encouragement, goal design (such as reducing dietary sugar), feedback and behavioral assessment, and the use of experiences from successful disease patients will be used.In the second session, after reviewing the sessions, the patient will be asked to talk about the emotions and ambiguities of her illness. The unique interventions will be adjusted according to the patient's need. Training will be designed to change the misconception and negative perception of the disease.Patients will be told if they have left a question beforehand, they can ask the researcher. In the third session (evaluation and termination), the patient will be notified of the appointment before the end of the session. First, review the training of the previous sessions, and then ask the patient about the effects of new training and experiences. Problems and barriers will be investigated for each patient. At the end of the third session, an educational booklet containing of items such as: diagnosis and definition of the diseases, points that must be observed in the diet, exercising and playing sports and also a short explanation of the laboratory finding, prepared and planned by the researcher,is given to the patient.</i_keyword>
      <i_keyword>Control group: In the control group, no intervention was performed by the researcher and patients received only routine hospital care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Illness perception. Timepoint: Before and After Intervention. Method of measurement: Illness perception 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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-17</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences, Shahid Bahonar Blvd Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
