<?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>IRCT20130611013636N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-31</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-care education through multimedia in the family of cancer children</public_title>
      <acronym></acronym>
      <scientific_title>Effect of self-care empowerment program by multimedia on the level of spiritual health and caring stress in the cancerous children's family</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>29</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32574</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: By using random block method (formation of four blocks), the samples were divided into intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cancerous children's family.</hc_freetext>
      <i_freetext>Intervention 1: The intervention and control groups completed the questionnaires before intervention. Then the training software was given .to intervention group.  Follow up was done  through a telegram channel with intervention group for 4 months. After the intervention both groups completed the questionnaires. 	Spiritual strategy for counseling:1	Cancer, causes and methods of treatment and care, coping with the complications of the disease.2	-problems of   cancerous children home care. Care pressure, causes and consequences.3	-Empowerment, strategy to reduce the pressure of care.4	 Empowerment Factors: Knowledge and Skills, Trust in God, Development of Communications, Strengthening Motivation	5 Family Spiritual Empowerment Program", Definition of Spirituality, Positive Impact of Spirituality on Health, Spiritual Health 6	- Spiritual well-being, having sound heart, soul abilities, effects spiritual health on the bio- Psycho - social health.7	- Characteristics of spiritual health, characteristics of the owners of the sound  heart , Imam Ali (as) a perfect man 8	- When do we need spiritual self-care? Who are the providers of spiritual care? Parents as spiritual counselors 9	- Causes of physical and mental illness, spiritual distress, "frustration of God's mercy", cause of spiritual illness 10	- The disease as a divine test, the philosophy of human testing, strategies for coping with stress (patience, faith, piety , submission to God's will, attention to the presence of God and the instability of hardship)11	- Creating the courage to face the disease by developing contact with God, faith-therapy (remembrance of God, prayer, hope, positive thinking)12	- Prayer therapy, effects of prayer, touch with healing prayers, Islamic ritual of sleep 13	- Spiritual self-care, the need to pay attention to spiritual illnesses, types of spiritual distresses 14	- Spiritual self-awareness, spiritual care guidelines based on religious evidence 15	- Character of spiritual caregivers, ways to communicate with a sick child, family, and friends. Generosity, pardon another mistake, kindness 16	- Use of nature blessings, motivation and motivational enhancement methods. Intervention 2: The control group: : They completed the questionnaires before the intervention. They received only routine care.Care was taken at home based on the doctor's order. After 4 months, completed the questionnaires. Then the educational software was donated. Questions were  answered.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The need for confidentiality of personal information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Minoo asadzandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Academic Organization of the University of Allah</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 7743 6665</telephone>
        <email>zandi498@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minoo Asadzandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vanak Square - Mulla Sadra Street - intersection of Sheikh Baha'i</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۵۹۱۵۳۷۱</zip>
        <telephone>+98 88050436</telephone>
        <email>zandi498@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being able to communicate to complete the questionnaire;
Do not list the history of chronic mental illness in the past and now (no use of psychotherapy);
Non-use of psychotropic drugs. 4. Familiarity with Farsi language. 5. Not having a child with other illnesses in the family.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No desire to continue research;
Coincident in another research;
The emergence of an important life crisis in addition to the child's disease crisis during the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention and control groups completed the questionnaires before intervention. Then the training software was given .to intervention group.  Follow up was done  through a telegram channel with intervention group for 4 months. After the intervention both groups completed the questionnaires. 	Spiritual strategy for counseling:1	Cancer, causes and methods of treatment and care, coping with the complications of the disease.2	-problems of   cancerous children home care. Care pressure, causes and consequences.3	-Empowerment, strategy to reduce the pressure of care.4	 Empowerment Factors: Knowledge and Skills, Trust in God, Development of Communications, Strengthening Motivation	5 Family Spiritual Empowerment Program", Definition of Spirituality, Positive Impact of Spirituality on Health, Spiritual Health 6	- Spiritual well-being, having sound heart, soul abilities, effects spiritual health on the bio- Psycho - social health.7	- Characteristics of spiritual health, characteristics of the owners of the sound  heart , Imam Ali (as) a perfect man 8	- When do we need spiritual self-care? Who are the providers of spiritual care? Parents as spiritual counselors 9	- Causes of physical and mental illness, spiritual distress, "frustration of God's mercy", cause of spiritual illness 10	- The disease as a divine test, the philosophy of human testing, strategies for coping with stress (patience, faith, piety , submission to God's will, attention to the presence of God and the instability of hardship)11	- Creating the courage to face the disease by developing contact with God, faith-therapy (remembrance of God, prayer, hope, positive thinking)12	- Prayer therapy, effects of prayer, touch with healing prayers, Islamic ritual of sleep 13	- Spiritual self-care, the need to pay attention to spiritual illnesses, types of spiritual distresses 14	- Spiritual self-awareness, spiritual care guidelines based on religious evidence 15	- Character of spiritual caregivers, ways to communicate with a sick child, family, and friends. Generosity, pardon another mistake, kindness 16	- Use of nature blessings, motivation and motivational enhancement methods</i_keyword>
      <i_keyword>The control group: : They completed the questionnaires before the intervention. They received only routine care.Care was taken at home based on the doctor's order. After 4 months, completed the questionnaires. Then the educational software was donated. Questions were  answered</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Caregiver's questionnaire has 24 phrases that have objective and subjective care pressure. The questionnaire has five subscales: time-dependent care pressure, evolutionary care pressure, physical care pressure, social care pressure and emotional well-being. Timepoint: 3 months after the end  intervention. Method of measurement: The Palutzin and Ellison Spiritual Wellness Questionnaire : Contains 20 terms that are divided into two groups of religious health and existential health. Ten sentences for each episode. The total score is 20- 120.</prim_outcome>
      <prim_outcome>GHQ General Health Questionnaire:   for investigating  non-psychiatric disorders and assess mental health status. It has  28-item with four scales. Each scale has seven questions. Four categories of non-psychotic disorders include: 1. Physical syndrome 2. Anxiety and sleep disorder 3. Disorders of social function 4. Detection of depression and suicidal tendency. Timepoint: 3 months after intervention. Method of measurement: Anxiety , Depression, Stress Questionnaire:  Investigates depression, anxiety and stress (emotional reactions). This questionnaire was first presented by Leviband and Leviiband in 1995.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Spiritual well-bein at the score. Timepoint: 3 months after intervention. Method of measurement: Spiritual health questionnaire:The questionnaire contains 20 sentences, which correspond to the Likert scale of six (I totally agree, agree, agree, slightly agree, rather disagree, totally disagree). This scale is divided into two groups of religious health and existential health, each containing ten sentences and a score of 10 to 60. The total spiritual health score is the sum of these two subgroups, which range between 120-20 The ranking of grades will be as follows.</sec_outcome>
      <sec_outcome>General Health Score. Timepoint: 3 months after intervention. Method of measurement: General Health Questionnaire: The 28 questions of this questionnaire, which are used in this study, have four levels, and each scale has seven questions. Four categories of non-psychotic disorders include: 1. Physical syndrome 2. Sleep disorder anxiety 3. -Discussion of social functions 4. -Depression.</sec_outcome>
      <sec_outcome>Anxiety،depression،strees. Timepoint: 3 months after intervention. Method of measurement: questionnaire depression anxity stress :A standardized questionnaire that examines depression, anxiety and stress (DAS), which has 21 statements, includes the most common, low, moderate and high options. The lowest score for each question is zero and the highest score is 3.</sec_outcome>
      <sec_outcome>Care pressure score. Timepoint: before and  after the intervention. Method of measurement: Twenty-four-item care-intensive care questionnaire has been developed to measure objective and subjective care pressure. The questionnaire has five subscales: time-dependent care pressure, evolutionary care pressure, physical care pressure, social care pressure and emotional well-being.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-03</approval_date>
        <contact_name>University of Baghiat Allah</contact_name>
        <contact_address>Tehran,: Vanak Square, Mullasadra Street, after Sheikh Bahai Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
