<?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>IRCT20220724055542N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-26</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>The effect of family-centered empowerment model based on mucosal management on the quality of life of parents and children with cancer undergoing chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effect of the family-centered empowerment model based on mucositis management on the quality of life of parents and children with cancer undergoing chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64941</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: They were selected from the convenient sampling method and then divided into two intervention and control groups by random allocation method. Random allocation sequence (20 blocks of 4) was determined using Random Allocation Software. For concealment, closed envelopes containing cards with red color (for the intervention group) and blue color (for the control group) were prepared according to the predetermined allocation sequence, Blinding description: The data analyst and reasercher were  blinded to the allocation of participants to study groups to ensure that all analytical decisions were made unbiased.</study_design>
      <phase>3</phase>
      <hc_freetext>cancer.</hc_freetext>
      <i_freetext>Intervention 1: Control group:did not receive any training. Intervention 2: Intervention group: The trainings are as much as possible face-to-face in eight sessions (one session per week must be face-to-face) and in the form of four topics (threat understanding, problem solving, participation and evaluation) according to Alhani's family-centered empowerment model, three times a week and every time It took place for 20 minutes.</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 I am planning with the supervisor to release the data.
 "There is no further information".</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasim Heydari Farsani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, West DEHGHAN Ave</address>
        <city>SHAHREKORD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8861638137</zip>
        <telephone>00933833222603</telephone>
        <email>NASIMH2510@GMAIL.COM</email>
        <affiliation>The University OF SHAHREKORD</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>NASIM HEIDARI FARSANI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, West DEHGHAN Ave</address>
        <city>SHAHREKORD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8861638137</zip>
        <telephone>+98 38 3222 2603</telephone>
        <email>NASIMH2510@GMAIL.COM</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having the informed consent of the parents of children with cancer to participate in the study
Having a child under the age of 18 with a definite diagnosis of cancer and undergoing chemotherapy
Parents should be able to communicate (speech)
. Parents not suffering from special diseases such as debilitating disease
Lack of previous participation of parents in empowerment programs
The absence of mucositis in the child at the time of entering the study
At least one month has passed since the diagnosis of the disease
Having a smartphone and virtual space9. Ability to use virtual space</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Withdrawal of the person during the research
The death of a child in the research
Occurrence of physical or mental problems for parents to the extent that the person is not able to continue cooperation
Failure to participate in two face-to-face meetings and two online meetings
Failure to answer the questionnaire questions completely</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C81-C96</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group:did not receive any training</i_keyword>
      <i_keyword>Intervention group: The trainings are as much as possible face-to-face in eight sessions (one session per week must be face-to-face) and in the form of four topics (threat understanding, problem solving, participation and evaluation) according to Alhani's family-centered empowerment model, three times a week and every time It took place for 20 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mucosit. Timepoint: Before, one. Three months after the intervention. Method of measurement: who.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Children's quality of life. Timepoint: Before, one. Three months after the intervention. Method of measurement: Children's quality of life questionnaire from parents' point of view (ped quality of life).</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before, one. Three months after the intervention. Method of measurement: sf36.</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>Shahrekord Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-14</approval_date>
        <contact_name>Ethics Committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>e.g.   No. 7, Westrahmatieh Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
