<?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>IRCT20141216020344N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-22</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of family-centered education on anxiety and stress of parents</public_title>
      <acronym>دیابت</acronym>
      <scientific_title>The effect of family-centered education on anxiety and stress of parents with a child with diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61531</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The family-centered model is implemented in four stages of perceived threat, self-efficacy, educational participation and evaluation during four sessions of 20 to 40 minutes for the intervention group; The control group receives only routine ward care. According to this model, the first step in the intervention phase is to understand the threat, which in this phase increases the knowledge and awareness of the parents. The use of drugs and the spirit and follow-up of tests and treatment is done. The second step is the problem-solving stage, which is done to increase self-esteem and self-control. In this stage, when parents' knowledge and attitude about the disease increase, they should participate in care programs. The third step is educational participation. The fourth step is evaluation, which is measured in two stages, one at the end of the intervention and one month later. Parents are first asked to complete the parent questionnaire. Then four 40-minute sessions are performed in four consecutive weeks (one session per week, every day). Before each session with the parents, the meeting time is set and the sessions are held for their convenience in the ward study class. In the first session (40 minutes), the researcher uses face-to-face training with parents about childhood diabetes, common signs and symptoms, diagnostic methods. And treatment programs, depending on the stage and condition of the child's illness; Then, these parents are given basic training in this field. It should be noted that this session is provided separately and to all parents in the intervention group. To implement the second stage of the empowerment model, parents are placed in groups of 6 to 3 people. Second, 40 minutes, they are asked to discuss ways to communicate and exchange ideas with the hospital treatment team. In this session, they share their experiences and information about treatment, evaluation and control of treatment side effects. Other topics discussed in this session include proper nutrition, hygiene and how to inject insulin, side effects of medications, improving self-control in the face of sick children and their problems, as well as ways to support other family members. During this session, the researcher tries to lead the discussion indirectly. During the third session, and in order to implement the third stage of the empowerment model, each participant is asked to go to one of his / her family members, who is responsible for caring for the child. , To teach about what they have learned in the last two sessions. , And answer the researcher's questions under his / her indirect supervision. During this session, any possible problems, such as forgetting the material or passing on incorrect information by the trained parents, will be corrected immediately by the researcher. In the fourth session or the final evaluation session, the researcher evaluates all the questions of the participants in the intervention group by asking questions about the whole content taught and the items that were discussed in the second and third sessions. Eventually removes the remaining ambiguities. It is important to note that the subject of the previous session is evaluated by the researcher and at the beginning of each session by asking one or two questions. For one person and the absence of a family member in the third training session, leads to their removal from the entire study. Intervention 2: Control group: In the control group, routine care is performed and family-centered interventions are not performed.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data is encrypted in order to make the identity of individuals unidentifiable and confidential

When:
From the end of sampling to 6 months after the publication of the article

To whom:
University Ethics Committee, Project Arbitration Committee, Article Arbitration Committee and other researchers

Conditions:
Perform systematic review or meta-analysis by mentioning the document

Where to obtain:
Dr Hamidreza Khoshnezhad Ebrahimi
Email address:khoshnezhad.hr@iums.ac.ir

How to obtain:
After submitting the application via academic email, we will provide the information files to the individuals within a maximum of one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Hamidreza Khoshnezhad Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2222 2045</telephone>
        <email>khoshnezhad.hr@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Hamidreza Khoshnezhad Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2222 2045</telephone>
        <email>khoshnezhad.hr@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Parents of children 6 to 15 years old with diabetes
Awareness of the type of child's disease
No stressful event other than the child's illness during the past year
Absence from attending similar training sessions and classes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of parental cooperation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The family-centered model is implemented in four stages of perceived threat, self-efficacy, educational participation and evaluation during four sessions of 20 to 40 minutes for the intervention group; The control group receives only routine ward care. According to this model, the first step in the intervention phase is to understand the threat, which in this phase increases the knowledge and awareness of the parents. The use of drugs and the spirit and follow-up of tests and treatment is done. The second step is the problem-solving stage, which is done to increase self-esteem and self-control. In this stage, when parents' knowledge and attitude about the disease increase, they should participate in care programs. The third step is educational participation. The fourth step is evaluation, which is measured in two stages, one at the end of the intervention and one month later. Parents are first asked to complete the parent questionnaire. Then four 40-minute sessions are performed in four consecutive weeks (one session per week, every day). Before each session with the parents, the meeting time is set and the sessions are held for their convenience in the ward study class. In the first session (40 minutes), the researcher uses face-to-face training with parents about childhood diabetes, common signs and symptoms, diagnostic methods. And treatment programs, depending on the stage and condition of the child's illness; Then, these parents are given basic training in this field. It should be noted that this session is provided separately and to all parents in the intervention group. To implement the second stage of the empowerment model, parents are placed in groups of 6 to 3 people. Second, 40 minutes, they are asked to discuss ways to communicate and exchange ideas with the hospital treatment team. In this session, they share their experiences and information about treatment, evaluation and control of treatment side effects. Other topics discussed in this session include proper nutrition, hygiene and how to inject insulin, side effects of medications, improving self-control in the face of sick children and their problems, as well as ways to support other family members. During this session, the researcher tries to lead the discussion indirectly. During the third session, and in order to implement the third stage of the empowerment model, each participant is asked to go to one of his / her family members, who is responsible for caring for the child. , To teach about what they have learned in the last two sessions. , And answer the researcher's questions under his / her indirect supervision. During this session, any possible problems, such as forgetting the material or passing on incorrect information by the trained parents, will be corrected immediately by the researcher. In the fourth session or the final evaluation session, the researcher evaluates all the questions of the participants in the intervention group by asking questions about the whole content taught and the items that were discussed in the second and third sessions. Eventually removes the remaining ambiguities. It is important to note that the subject of the previous session is evaluated by the researcher and at the beginning of each session by asking one or two questions. For one person and the absence of a family member in the third training session, leads to their removal from the entire study.</i_keyword>
      <i_keyword>Control group: In the control group, routine care is performed and family-centered interventions are not performed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before intervention and immediately after intervention and one month after intervention. Method of measurement: Beck Anxiety Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stress. Timepoint: Before intervention and immediately after intervention and one month after intervention. Method of measurement: Life Stress Questionnaire (LDI).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-26</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
