<?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>IRCT20171103037191N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-17</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Increasing the understanding Of Gestational Diabetes Patients on Perceived Stress</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Illness Perception Educational Intervention on Perceived Stress of Women with Gestational Diabetics Rasht (2017)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28305</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random Block, Individual, Quadruple Blocking.</study_design>
      <phase>3</phase>
      <hc_freetext>Gestational Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention based on individual disease (face to face training) in 3 sessions of 30 minutes in 3 consecutive days in the morning shift. Session 1: At the first session, after initial communication with the patient and asking questions about his understanding of the current condition and its implications, the content will be presented. This session is based on five dimensions of understanding the illness and the impact of understanding the illness on psychological outcomes. These dimensions include the nature of the disease (on the adhesive and symptoms associated with the disease, such as fatigue, weakness); the cause of the onset of the disease; the duration or perception of the person during the illness; the outcomes and expected findings of the person from the disease; the effectiveness of control, treatment and improvement of the disease will be. To interfere with the understanding of the disease, 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. Session 2: After reviewing the session's training, 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. At the end of the second session of the booklet, which includes identifying and defining the disease, what should be observed in your diet, physical activity and exercise, a brief explanation of the laboratory findings and psychological recommendations for reducing stress that the researcher will provide and Will be made available to the patient. Third Session (Evaluation and Closing): The session will be informed to the patient about this closing 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. Intervention 2: Control group: In this group, there will be no intervention by the researcher and patients will only receive routine 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 28333360015</telephone>
        <email>nbahrami@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad Ali soleimani</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 28333360015</telephone>
        <email>soleimany.msn@gmail.com</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 then Gestational Diabetes
lack of Recognized and recognized Psychological illness based on self_declaration
Not having of Gestational Diabetes during the pregnancy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Any complications of mother and fetus
Transfer to a treatment center during the study</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 individual disease (face to face training) in 3 sessions of 30 minutes in 3 consecutive days in the morning shift. Session 1: At the first session, after initial communication with the patient and asking questions about his understanding of the current condition and its implications, the content will be presented. This session is based on five dimensions of understanding the illness and the impact of understanding the illness on psychological outcomes. These dimensions include the nature of the disease (on the adhesive and symptoms associated with the disease, such as fatigue, weakness); the cause of the onset of the disease; the duration or perception of the person during the illness; the outcomes and expected findings of the person from the disease; the effectiveness of control, treatment and improvement of the disease will be. To interfere with the understanding of the disease, 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. Session 2: After reviewing the session's training, 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. At the end of the second session of the booklet, which includes identifying and defining the disease, what should be observed in your diet, physical activity and exercise, a brief explanation of the laboratory findings and psychological recommendations for reducing stress that the researcher will provide and Will be made available to the patient. Third Session (Evaluation and Closing): The session will be informed to the patient about this closing 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.</i_keyword>
      <i_keyword>Control group: In this group, there will be no intervention by the researcher and patients will only receive routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived Stress. Timepoint: before and after intervention. Method of measurement: Cohen Perceived Stress scale.</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>2017-11-22</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>
