<?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>IRCT20201107049293N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-01</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of healthy sleep pattern education in  sleepiness  reduction</public_title>
      <acronym></acronym>
      <scientific_title>Development and evaluation of the effectiveness of virtual education program for healthy sleep pattern on sleepiness  reduction in 15 to 17 years old female students.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52106</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A two-arm parallel-randomized controlled trial with sleep intervention and a control group, with 53 people sample size in each group. 
Using simple randomization method, two school will be randomly selected out of five schools. Out of two schools, one is randomly assigned to control group and one to the experimental group. Then, in every school each class is given a number and two numbers randomly will be selected and assigned to the experimental and control classes. In this study, to units of the statistical society (schools or classes) will be assigned a card number and then will be put all the cards in a box And every time after shaking the box, we will be Draw the card randomly from the box.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The students sleepiness.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 15-17-year-old female high school students. Self-regulation theory is the selection of intervention components and behavior change techniques and is the basis of all educational materials. Students in the sleep education program will receive 12 sessions (30 minutes each) online. The training program used in this study will include sleep knowledge, sleep hygiene and goal setting, self-control (including metacognitive and motivational strategies) and self-reflection.The content of the training will be presented to the intervention group in the form of PowerPoint, multimedia, short audio and text files. The intervention group will be invited to join a social network for example, WhatsApp or Instagram for 12 weeks to share their experiences with barriers and solutions to overcome healthy sleep barriers. A telephone consultation will be added to the program to maximize program participation and increase problem-solving and self-regulation skills. Educational intervention will be done in SHAD program and a link to educational sessions will be sent to students every week. Coordination and planning will be done with the school principal before the intervention. Intervention 2: Control group: 17-15 year old female high school students. Students in the control group do not receive educational intervention But the content of the training will be provided to them after the end of the study.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data and results of the intervention and the intervention protocol potentially will be published as a scientific article

When:
Accessibility after printing results

To whom:
There is no limitation for statistical analysis

Conditions:
Obtaining official permission from Isfahan University of Medical Sciences - Contact the research team-There is no limitation for statistical analysis

Where to obtain:
Isfahan University of Medical Sciences

How to obtain:
Obtaining official permission from Isfahan University of Medical Sciences - Contact the research team

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parvin Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib street,, Isfahan University of Medical Sciences.Faculty of Health</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۳۴۶۱-۸۱۷۴۶</zip>
        <telephone>+98 31 3792 3204</telephone>
        <email>parvin_ghasemi@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Amidi Mazaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib street, Isfahan University Of Medical Science ,Faculty of Health</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۳۴۶۱-۸۱۷۴۶</zip>
        <telephone>+98 31 3792 3204</telephone>
        <email>maryamamidi@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female students studying in high school
Parents' consent to participate in the study
willing to participate in the study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The usage of  medication which  causes sleep disorders</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 15-17-year-old female high school students. Self-regulation theory is the selection of intervention components and behavior change techniques and is the basis of all educational materials. Students in the sleep education program will receive 12 sessions (30 minutes each) online. The training program used in this study will include sleep knowledge, sleep hygiene and goal setting, self-control (including metacognitive and motivational strategies) and self-reflection.The content of the training will be presented to the intervention group in the form of PowerPoint, multimedia, short audio and text files. The intervention group will be invited to join a social network for example, WhatsApp or Instagram for 12 weeks to share their experiences with barriers and solutions to overcome healthy sleep barriers. A telephone consultation will be added to the program to maximize program participation and increase problem-solving and self-regulation skills. Educational intervention will be done in SHAD program and a link to educational sessions will be sent to students every week. Coordination and planning will be done with the school principal before the intervention.</i_keyword>
      <i_keyword>Control group: 17-15 year old female high school students. Students in the control group do not receive educational intervention But the content of the training will be provided to them after the end of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean sleep knowledge score. Timepoint: Before, after and 3 months after the intervention. Method of measurement: Cognitive variables questionnaire.</prim_outcome>
      <prim_outcome>Mean score of sleep health. Timepoint: Before, after and 3 months after the intervention. Method of measurement: Adolescent Sleep Hygiene Scale.</prim_outcome>
      <prim_outcome>Mean score quality of sleep. Timepoint: Before, after and 3 months after the intervention. Method of measurement: Pittsburgh Sleep Quality Index.</prim_outcome>
      <prim_outcome>Mean score of self-regulation sleep behavior. Timepoint: Before, after and 3 months after the intervention. Method of measurement: Sleep Behavior Self-Regulation Questionnaire.</prim_outcome>
      <prim_outcome>Mean  score of sleepiness. Timepoint: Before, after and 3 months after the intervention. Method of measurement: Cleveland Adolescent Sleepiness Questionnaire.</prim_outcome>
      <prim_outcome>Attitude towards sleep. Timepoint: Before, after and 3 months after the intervention. Method of measurement: Cognitive variables questionnaire.</prim_outcome>
      <prim_outcome>Mean score of sleep behavior self-efficacy. Timepoint: Before, after and 3 months after the intervention. Method of measurement: Cognitive variables 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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-18</approval_date>
        <contact_name>Ethics committee of  Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib street, Isfahan University of Medical Sciences,Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
