<?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>IRCT20200202046339N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-17</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Examining the Effectiveness of solution-focused brief consolation  on mothers with gestational diabetes under insulin treatment</public_title>
      <acronym></acronym>
      <scientific_title>Examining the Effectiveness of solution-focused brief consulation with emphasis on self-efficacy on stress and depression and anexity  of mothers with gestational diabetes under insulin treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45512</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Urn RandomizationUrn  method was used to allocate individuals in each study group A research assistant who was not involved in the recruitment of participants prepared the 56 papers, 
back of 56 paper  was written control or intervention group,He mixed it up, provided one of the relevant papers for every one  . Participants allocated to the control group (n = 28) received standard care. Participants assigned to the intervention group (n = 28) also received standard care plus solution-focused
 brief consolation , The intervention consisted of 6 solution-based counseling sessions that were held weekly before the intervention questionnaires were completed by two group .6 weeks and 16 weeks after the intervention, the post test was conducted for both experimental and control groups to  evaluate the effect of the intervention after the intervention and 16 weeks after the intervention, Blinding description: due to nature of intervention  participants and resercher was not blind but Outcome assessors and analyzer were  blind.</study_design>
      <phase>3</phase>
      <hc_freetext>stress,anexity,depression, in mothers with gdm.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: prenatal care + intervention ,Intervention consist of 6session: In the first session, introduction, After that, mothers were provided with the content of Principles of solution-focused brief  consultation  , the mothers were provided with information about diabetes and help them , identification of the problem, clearly , How does gestational diabetes affect  mother and her child?2- In the second session setting the  goals of consultation in gdm In this session participants were Helped  understand their abilities,  participants  were educated to understand each other's perspectives, motivating each other, who is at risk for pregnancy complications , creation of alternative solutions, the participants were taught about the effect of the diabet  on pregnancy and self-care (nutrition, physical activity, prevention of infection, vaccination, drug, etc.). 3 In the third session,--Change viewpoint and highlight self-efficacy In this session, the participants were taught about the effect of the diabet  on pregnancy and self-care (nutrition, physical activity prevention  of infection, vaccination, drug, etc assessment of consequences, selection of the solution , how to treat gestational diabetes, diet and exercise in gestational diabetes and self care, daydreaming.).	Principles of self-care- 4In the forth session- use of Practical Techniques in problem solving  and the Nutritionist's Guide and exercise and treatment In Gestational Diabetes were taught, the interventionist emphasized understanding one’s own thoughts and feelings and modifying self-dialogue towards more positive messaging. Therefore, the patients were taught to reflect on their thinking and respond to situations, solved the  problems, and used their thoughts to help follow through with the decision they made previously, and evaluation of the outcomes Using a miracle question by a consultant And consulting with the person who understands the good and the bad moments is the result of his thoughts and behavior , Blood glucose monitoring,  use of Glucometer, Assignment	. 5In fifth session,Use Principles of problem solving consultation  (miracle and scale questions) and monitor blood sugar	 Pregnancy with normal gestational diabetes, Relaxation,normal delivery or c/section in gdm , 6-In the last session( final) the interventionist summarizing the content  and emphasize  postpartum blood glucose monitor,  the intervention were evaluated. Moreover, the interventionist answered the mothers’ questions  Use the word instead to experience new emotions Highlighting responses to postpartum maternal hyperglycemia, relaxation,. Intervention 2: Control group:just  take routinize prenatal 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 there is not more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rafiee Zahra</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Apt Naqshe Gahan,No15 Edalat,Ensegam,QOM</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713436969</zip>
        <telephone>+98 25 3289 6264</telephone>
        <email>Zrfyy475@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vakilian Katayon</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical University, Basij Squre, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>38481-7-6941</zip>
        <telephone>+908634173638</telephone>
        <email>cattyv2002@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers  at10-38 week gestational age
Mothers   Have at least a fifth grade(primary) education
non-smoking and no addiction to psychological drug or alcohol,...
no history of medical illnesses, such as, cardiovascular diseases, hypertension, epilepsy, migraine,  thyroid disease, connective tissue disease, asthma, respiratory disorders, kidney failure, anemia, and stroke,
no  histotry of  hospitalization due to mental illnesses or abuse of psychological drugs
under insulin treatment
singleton pregnancy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>individuals who were unwilling to continue the research
absent more than one session, of 6 consultation sessions.
who experienced  pregnancy-related complications, including bleeding, hypertension, early delivery, and surgery or hospitalization for current pregnancy, as well as delivery or abortion during the study
severe psychiatric disorders or disaster, happened in pregnancy
occurrence of major stressful events 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>Lifestyle</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: prenatal care + intervention ,Intervention consist of 6session: In the first session, introduction, After that, mothers were provided with the content of Principles of solution-focused brief  consultation  , the mothers were provided with information about diabetes and help them , identification of the problem, clearly , How does gestational diabetes affect  mother and her child?2- In the second session setting the  goals of consultation in gdm In this session participants were Helped  understand their abilities,  participants  were educated to understand each other's perspectives, motivating each other, who is at risk for pregnancy complications , creation of alternative solutions, the participants were taught about the effect of the diabet  on pregnancy and self-care (nutrition, physical activity, prevention of infection, vaccination, drug, etc.). 3 In the third session,--Change viewpoint and highlight self-efficacy In this session, the participants were taught about the effect of the diabet  on pregnancy and self-care (nutrition, physical activity prevention  of infection, vaccination, drug, etc assessment of consequences, selection of the solution , how to treat gestational diabetes, diet and exercise in gestational diabetes and self care, daydreaming.).	Principles of self-care- 4In the forth session- use of Practical Techniques in problem solving  and the Nutritionist's Guide and exercise and treatment In Gestational Diabetes were taught, the interventionist emphasized understanding one’s own thoughts and feelings and modifying self-dialogue towards more positive messaging. Therefore, the patients were taught to reflect on their thinking and respond to situations, solved the  problems, and used their thoughts to help follow through with the decision they made previously, and evaluation of the outcomes Using a miracle question by a consultant And consulting with the person who understands the good and the bad moments is the result of his thoughts and behavior , Blood glucose monitoring,  use of Glucometer, Assignment	. 5In fifth session,Use Principles of problem solving consultation  (miracle and scale questions) and monitor blood sugar	 Pregnancy with normal gestational diabetes, Relaxation,normal delivery or c/section in gdm , 6-In the last session( final) the interventionist summarizing the content  and emphasize  postpartum blood glucose monitor,  the intervention were evaluated. Moreover, the interventionist answered the mothers’ questions  Use the word instead to experience new emotions Highlighting responses to postpartum maternal hyperglycemia, relaxation,</i_keyword>
      <i_keyword>Control group:just  take routinize prenatal care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress score in dass21 scale. Timepoint: Before intervention, 6 week and 16 week after intervention. Method of measurement: dass21 scale.</prim_outcome>
      <prim_outcome>Anexity score in dass21 scale. Timepoint: Before intervention,6 week and 16 week after intervention. Method of measurement: dass21 scale.</prim_outcome>
      <prim_outcome>Depression score in dass21 scale. Timepoint: Before intervention,6 week and 16 week after intervention. Method of measurement: dass21 scale.</prim_outcome>
      <prim_outcome>Behavioral sterategies for coping with  steress. Timepoint: Before intervention,6 week and 16 week after intervention. Method of measurement: ciss scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self efficacy. Timepoint: Before intervention,6 week ,16 week after intervention. Method of measurement: Dmses scale.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-15</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Naghshe jahan Apt,No. 15, EDALATAvenu, Ensegam street , Qom Town Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
