<?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>IRCT20220327054359N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-04</date_registration>
      <primary_sponsor>Islamic Azad University, Aliabad Katoul Branch</primary_sponsor>
      <public_title>The effect of spiritual self-care training on the severity of insomnia and sleep quality of diabetic adolescents</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of spiritual self-care training on sleep quality and insomnia severity in adolescents with diabetes and its comparison with the control group</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62971</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Firstly, the samples will be selected by available sampling method as follows: After obtaining consent and stating the targets and providing the necessary information, the questionnaire severity insomnia and the Petersburg Quality of Sleep Questionnaire will be completed by diabetic patients with the help of a researcher.Then by using a secret envelope, will be selected for randomization into two groups of test and control. For randomization, the secret letters which previously prepared that containing numbers 1 (control group) and numbers 2 (test group) are given to individuals.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Insomnia and decreased sleep quality in diabetic adolescents.</hc_freetext>
      <i_freetext>Intervention 1: Test group is diabetic adolescents 12 to 20 years that educated in White's spiritual self care training. White's spiritual self-care training is held in 6 sessions of 30 to 45 minutes. This training is in 5 areas: Self control, Performing religious duties, Personal activities, Getting close to God, Asking God for help. Intervention 2: Control group: This group are not trained and receives routine care. After completing the research educational materials will be provided to them.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Valipour Eskandarkolaii</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University blvd</address>
        <city>Aliabad katul</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4941793451</zip>
        <telephone>+98 17 3422 2300</telephone>
        <email>valipourelhame@gmail.com</email>
        <affiliation>Islamic Azad University, Aliabad Katoul Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nafise Hekmatipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Blvd</address>
        <city>Ali Abad katol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>93451-49417</zip>
        <telephone>+98 911 279 9047</telephone>
        <email>n_hekmati68@yahoo.com</email>
        <affiliation>Islamic Azad University, Ali Abad katol Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having diabetes
Age range between 20 to12 years
Family satisfaction with the continuous participation of the subjects in the training sessions
No history of neurological and psychological diseases
No drug abuse
insomnia</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>20 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of various underlying diseases
Mental disability</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Test group is diabetic adolescents 12 to 20 years that educated in White's spiritual self care training. White's spiritual self-care training is held in 6 sessions of 30 to 45 minutes. This training is in 5 areas: Self control, Performing religious duties, Personal activities, Getting close to God, Asking God for help</i_keyword>
      <i_keyword>Control group: This group are not trained and receives routine care. After completing the research educational materials will be provided to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Earning score of 15 to 21 has meaning of moderate and 22 to 28 has meaning of severe insomnia in Insomnia Intensity questionnaire and earning score of 6 and more than 6 has meaning of unpleasant of sleep quality in Petersburg Sleep Quality Inventory. Timepoint: 30 DAYS. Method of measurement: Petersburg Sleep Quality Questionnaire and Insomnia Intensity 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>Islamic Azad University, Aliabad Katoul Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-13</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Dezful Branch</contact_name>
        <contact_address>University Blvd, Azadegan Street, Dezful Dezful Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
