<?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>IRCT20200112046102N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-09</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Survey the effect of continuous care model on psychiatry health and quality of life in mothers of children with cerebral palsy</public_title>
      <acronym></acronym>
      <scientific_title>Survey the effect of continuous care model on psychiatry health and quality of life in mothers of children with cerebral palsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50412</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random blocks and "Random allocation software" will be used for randomization. Given that we have two groups, four blocks will be used. The sequence of groups in each block will be determined by the software. To start,  the first block is selected by lottery and then this process will be done until the sampling is completed.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Quality of life. Condition 2: Mental health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention will be performed face to face and includes four training stages of the continuous care model in the internal ward of 17-Shahrivar Hospital in Rasht. In this way, after introducing themselves to the mothers and justifying the goals and methods of work and obtaining informed written consent, the researcher will be provided with mental health and quality of life questionnaires to mothers, and therefore mothers' mental health and quality of life before the intervention will be assessed. The continues care model will then be implemented for two months. The continues care model, which is the native care model of Iran, consists of four stages, which include the stage of identification, sensitization, control and evaluation. In the introductory phase, an hour-long session will be held with the presence of mothers with children with cerebral palsy. In person and by phone. In the sensitization phase, childcare counseling will be conducted both in person in six sessions and by telephone. At this stage, understanding the nature of the disease, early and late complications, how to use their child's medications, how to control anxiety and worry, strategies to improve mental health and quality of life such as following a healthy lifestyle, exercising, avoiding stress and anxiety They will be given and any questions and concerns will be answered. In the control phase, follow-up care counseling and re-sensitization will be provided on a weekly basis by telephone to review the achievement of follow-up care goals. In the evaluation phase, the researcher will examine the mothers. Then the quality of life and mental health will be measured again at the end of the first and second month using the mentioned questionnaires. Intervention 2: Control group: In the control group, quality of life and mental health questionnaires will be provided to them and only mothers will be provided with routine education about their child's illness and other care provided by the ward nurses. Quality of life and mental health will be measured again at the end of the first and second months using the mentioned questionnaires.</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 no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somaye Pouy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasin Ave., Daneshjo Park, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4144643199</zip>
        <telephone>+98 13 3355 7807</telephone>
        <email>somayepouy@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somaye Pouy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasin Ave., Daneshjo Park, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4144643199</zip>
        <telephone>+98 13 3355 7807</telephone>
        <email>somayepouy@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1-mothers who have 4 to 12 year-old  hospitalized children with cerebral palsy 
2- parents not working in health systems
3- no special problem affecting mothers' mental health such as financial crisis.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria are: mothers suffer from mental illness and severe anxiety.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></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 intervention will be performed face to face and includes four training stages of the continuous care model in the internal ward of 17-Shahrivar Hospital in Rasht. In this way, after introducing themselves to the mothers and justifying the goals and methods of work and obtaining informed written consent, the researcher will be provided with mental health and quality of life questionnaires to mothers, and therefore mothers' mental health and quality of life before the intervention will be assessed. The continues care model will then be implemented for two months. The continues care model, which is the native care model of Iran, consists of four stages, which include the stage of identification, sensitization, control and evaluation. In the introductory phase, an hour-long session will be held with the presence of mothers with children with cerebral palsy. In person and by phone. In the sensitization phase, childcare counseling will be conducted both in person in six sessions and by telephone. At this stage, understanding the nature of the disease, early and late complications, how to use their child's medications, how to control anxiety and worry, strategies to improve mental health and quality of life such as following a healthy lifestyle, exercising, avoiding stress and anxiety They will be given and any questions and concerns will be answered. In the control phase, follow-up care counseling and re-sensitization will be provided on a weekly basis by telephone to review the achievement of follow-up care goals. In the evaluation phase, the researcher will examine the mothers. Then the quality of life and mental health will be measured again at the end of the first and second month using the mentioned questionnaires.</i_keyword>
      <i_keyword>Control group: In the control group, quality of life and mental health questionnaires will be provided to them and only mothers will be provided with routine education about their child's illness and other care provided by the ward nurses. Quality of life and mental health will be measured again at the end of the first and second months using the mentioned questionnaires.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: The quality of life of both groups will be measured in three time periods, including after discharge, at the end of the first month and the second month. Method of measurement: Quality of life will be measured using a short form of quality of life.</prim_outcome>
      <prim_outcome>Mental health. Timepoint: Mental health of both groups will be measured in three time periods, including after discharge, at the end of the first month and the second month. Method of measurement: Mental health will be assessed by the General Psychological Health Questionnaire.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-16</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Daneshjoo Ave., Yakhsazi BLV., Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
