<?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>IRCT20211111053035N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-06</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of family centered care on parent's caregiver burden and self-efficacy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of Family Centered Care education to health care provider based on meaningful learning theory on caregiver burden and self-efficacy in the parents of hospitalized children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61405</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>Condition 1: Care burden. Condition 2: Parental self-efficacy. Condition 3: Patient and Family Centered Care. Condition 4: Meaningful learning.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention will be PFCC education based on David Azobel's theory of meaningful learning. Educational content will be presented in 5 educational sessions for 90 minutes after content validity. Training of 5 main sessions in accordance with the conditions of the Covid-19 pandemic will be done online by recording the content of the classes. So that the content of the meetings can be made available to people who could not attend the meetings. It will also be done in proportion to the time available in the discussion section on the subject at the time of changing shifts and with the presence of the maximum number of healthcare and during the group meetings of physicians. Performance of healthcare will be completed by a checklist for observing and evaluating the performance of the researcher in three different shifts for each health care, and if any of the options are not observed, the necessary explanations will be given to the health care. Due to the fact that patients and families are in more direct contact with physicians, nurses and assistant nurses, educational content will be provided to these three groups. After the training sessions, the approved plan is expected to be implemented during the training sessions during the work shifts and during the patient care-treatment process. At this time, the main role will be played by the honorable head of the ward and the head nurse of the ward in the implementation of the plan. The steps of teaching patient and family-centered content based on the theory of meaningful learning are described below. At the beginning of the meeting, the purpose of the meeting and a brief explanation of the topic is presented in the form of a question. Then the participants' knowledge of different aspects of the topic will be measured (pre-organizer). In the next step, participants are asked about what they do not know or would like to know about the topic (motivating and preparing for new knowledge). In the next stage, the new knowledge is taught by expressing the case method, giving similar examples and asking questions of the participants and asking them to express their similar experiences. Health care are then asked to apply what they have learned, ask parents about the issues raised, and finally participate in the next session by drawing a concept map of the content of the session (role of assignments in theory). Intervention 2: Control group: The control group will only complete the study questionnaires and will not receive any intervention.</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:
Unidentifiable demographic information is fully shareable.
The results of the questionnaires on family impact, self-efficacy, parents 'perception of family-centered care and health care providers' attitudes toward parental involvement in inpatient child care can be shared. Educational content is also shareable.

When:
It will be possible to share document from the time the results are published.

To whom:
Data file can be available for people working in academic institutions and students.

Conditions:
Nothing

Where to obtain:
1. To receive documents and data, send a request to the email address "smoutamedifard@razi.tums.ac.ir".
or
2. Sending request to "soheilamotamedifard@yahoo.com"

How to obtain:
Documents and information will be shared within one month of submitting the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soheila Moutamedifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Behesht 8 Alley, Dahdastgah Ave., Tohid Ave.</address>
        <city>Pishva</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3381947474</zip>
        <telephone>+98 21 3673 0678</telephone>
        <email>smoutamedifard@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheila Moutamedifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Behesht 8 Alley, Dahdastgah Alley, Tohid Ave.</address>
        <city>Pishva</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3381947474</zip>
        <telephone>+98 21 3673 0678</telephone>
        <email>smoutamedifard@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a child hospitalized because of chronic illness
Having a child hospitalized more than twice because of chronic illness
No parents or other family members have a chronic illness
The mother is not the head of the family</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>There is no criteria.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention will be PFCC education based on David Azobel's theory of meaningful learning. Educational content will be presented in 5 educational sessions for 90 minutes after content validity. Training of 5 main sessions in accordance with the conditions of the Covid-19 pandemic will be done online by recording the content of the classes. So that the content of the meetings can be made available to people who could not attend the meetings. It will also be done in proportion to the time available in the discussion section on the subject at the time of changing shifts and with the presence of the maximum number of healthcare and during the group meetings of physicians. Performance of healthcare will be completed by a checklist for observing and evaluating the performance of the researcher in three different shifts for each health care, and if any of the options are not observed, the necessary explanations will be given to the health care. Due to the fact that patients and families are in more direct contact with physicians, nurses and assistant nurses, educational content will be provided to these three groups. After the training sessions, the approved plan is expected to be implemented during the training sessions during the work shifts and during the patient care-treatment process. At this time, the main role will be played by the honorable head of the ward and the head nurse of the ward in the implementation of the plan. The steps of teaching patient and family-centered content based on the theory of meaningful learning are described below. At the beginning of the meeting, the purpose of the meeting and a brief explanation of the topic is presented in the form of a question. Then the participants' knowledge of different aspects of the topic will be measured (pre-organizer). In the next step, participants are asked about what they do not know or would like to know about the topic (motivating and preparing for new knowledge). In the next stage, the new knowledge is taught by expressing the case method, giving similar examples and asking questions of the participants and asking them to express their similar experiences. Health care are then asked to apply what they have learned, ask parents about the issues raised, and finally participate in the next session by drawing a concept map of the content of the session (role of assignments in theory).</i_keyword>
      <i_keyword>Control group: The control group will only complete the study questionnaires and will not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Care burden score in Family Impact Scale. Timepoint: Before intervention and 2 months after the last educational session for health care. Method of measurement: "Impact on family" scale for assessing parental care burden and.</prim_outcome>
      <prim_outcome>Parental self-efficacy score in perceived self-efficacy questionnaire. Timepoint: Before intervention and 2 months after the last educational session for health care. Method of measurement: "perceived maternal parenting self-efficacy" questionnaire far parental self-efficacy.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Perception score of family-centered care. Timepoint: Before intervention and 2 months after the last session of educating health care. Method of measurement: Perception family centered care of parents (PFCC-P).</sec_outcome>
      <sec_outcome>Health care attitudes scale toward parent participation in hospitalized children's care. Timepoint: Before intervention and 2 months after the last session of educating health care. Method of measurement: "Health professionals' attitudes toward parent participation in hospitalized children's care" 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>2021-09-01</approval_date>
        <contact_name>Ethics committee of nursing an midvifery school and Rehabilitation school of tehran university of me</contact_name>
        <contact_address>Nosrat St, District 6, Tehran Province,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
