<?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>IRCT20221119056541N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-13</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of art therapy on self-efficacy and self-concept of children and Adolescents Suffering of cancer: A clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of art therapy on self-efficacy and self-concept of children and Adolescents Suffering of cancer: A clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73657</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done using permutation block method.

The method used to generate a random allocation sequence by mentioning the name of the software or site used:

Using Sealed EnveloPe Ltd software. 2017 available through www.sealedenvelope.com five blocks of six and one block of four, a total of six blocks will be defined, which will be assigned to groups according to the order of the random list specified by the mentioned software, Blinding description: In this research, the person analyzing the data and assessing the outcome will not be aware of which group each person is in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Self-efficacy and self-concept.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this intervention, although people are placed in groups, in each session, the focus is on the implementation of the method for each person, and the supervision of this issue is the responsibility of the implementing coach, who is one of the researchers and has mastery of the work method. . The explanation of the coach's working method will be presented to the group in each session, and in the stage of implementation by children and teenagers, the coach will be fully supervised by the coach. The use of different arts are included in the content of the sessions and are performed in a way that encourages relaxation and introspection and creates a bond of feelings in people. At the beginning of each session, the trainer will give a welcome, warm-up exercise to prepare and create relaxation to enter the main exercise (the goal of each session). This initial exercise is planned by creating visualization for people for the main exercise that describes their situation or its solutions. Then, the practice of each session is done according to the content of that session by using accessible and low-cost artistic tools in a way that can put the person in the current mental state. After each exercise, people will be asked to express their feelings and then the instructor will help each person understand their artistic product. At the end of each session, there is a relaxation exercise with soft music and mental imagery to put yourself in a pleasant atmosphere along with breathing exercises, and the participants take their artwork home. On average, at the end of each session, the warm-up, relaxation and guided imagery phase will last 7-10 minutes; The stage of artistic output will last 60 minutes and the stage of verbal development will take 15 to 20 minutes. Intervention 2: Control group: They will not receive any additional 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Confidentiality of data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parichehr Shahroudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khazar Street, 18 Khazar Alley, three-story building</address>
        <city>Lahijan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4414886939</zip>
        <telephone>+98 13 4234 6128</telephone>
        <email>parichehr.shahroudi@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parand Pourghane</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>استان گیلان، رشت، دانشگاه علوم پزشکی گیلان، دانشکده پرستاری مامایی حضرت زینب</address>
        <city>رشت</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4477166595</zip>
        <telephone>+98 13 4256 5059</telephone>
        <email>pourghanep@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 5 to 18 years
Children diagnosed with various malignancies
Having the ability to read and write
Ability to participate in the program
Absence of severe stressful events (death of a first-degree relative, illness, accident, divorce of parents) during the past year</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence of pain based on VAS criteria
The presence of special problems such as autism and ADHD and...
Physical problems (verbal, mental, vision and hearing)
Lack of family satisfaction in children and adolescents under 18 years of age</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>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this intervention, although people are placed in groups, in each session, the focus is on the implementation of the method for each person, and the supervision of this issue is the responsibility of the implementing coach, who is one of the researchers and has mastery of the work method. . The explanation of the coach's working method will be presented to the group in each session, and in the stage of implementation by children and teenagers, the coach will be fully supervised by the coach. The use of different arts are included in the content of the sessions and are performed in a way that encourages relaxation and introspection and creates a bond of feelings in people. At the beginning of each session, the trainer will give a welcome, warm-up exercise to prepare and create relaxation to enter the main exercise (the goal of each session). This initial exercise is planned by creating visualization for people for the main exercise that describes their situation or its solutions. Then, the practice of each session is done according to the content of that session by using accessible and low-cost artistic tools in a way that can put the person in the current mental state. After each exercise, people will be asked to express their feelings and then the instructor will help each person understand their artistic product. At the end of each session, there is a relaxation exercise with soft music and mental imagery to put yourself in a pleasant atmosphere along with breathing exercises, and the participants take their artwork home. On average, at the end of each session, the warm-up, relaxation and guided imagery phase will last 7-10 minutes; The stage of artistic output will last 60 minutes and the stage of verbal development will take 15 to 20 minutes.</i_keyword>
      <i_keyword>Control group: They will not receive any additional intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-concept. Timepoint: Once, before the intervention and once, a month and a half after the intervention. Method of measurement: Using the Rogers self-concept scale: Rogers made this scale and it includes two forms. Form "A" measures the person's attitude towards the real self and form "B" measures the person's attitude towards the ideal self. Each form contains 25 personality traits, the opposite of which is stated on the other side. The distance between two opposite adjectives is graded with a seven-point scale. After scoring and calculating the total score of each subject, the type of self-concept is determined according to the obtained score. A total score of 0 to 7 indicates a positive self-concept, a score of 7 to 10 indicates a negative self-concept, and a score greater than 10 indicates a neurotic self-concept.</prim_outcome>
      <prim_outcome>Self-efficacy. Timepoint: Once, before the intervention and once, a month and a half after the intervention. Method of measurement: Using the child and adolescent self-efficacy questionnaire: Morris created this form in 2001 to measure the self-efficacy of children and adolescents (7-18 years old). The three subscales of this questionnaire are: social self-efficacy, academic self-efficacy and emotional self-efficacy. This questionnaire has 23 items and the answer to each item is according to a 5-point Likert scale from the option "not at all" = 1) to the option "very much" = 5 (47). The range of scores related to overall self-efficacy is 23-115. Social and academic self-efficacy is 8-10 and emotional self-efficacy is 7-35(48). A higher score means a higher level of self-efficacy.</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>2023-10-18</approval_date>
        <contact_name>کمیته اخلاق در پژوهش دانشگاه علوم پزشکی گیلان</contact_name>
        <contact_address>خیابان نامجو، خیابان شهید سیادتی، روبروی بیمارستان 17 شهریور رشت Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
