<?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>IRCT20241008063294N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-12-21</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of education on oral and dental health self-care behaviors of students</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of educational intervention based on Transtheoretical model in self-care behaviors of oral and dental health of students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79555</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The educational intervention of the present study is designed based on the Transtheoretical model, Randomization description: Simple randomness, Blinding description: In the present study, all the participants of the intervention and control groups, which include students aged 11 to 13 years, are considered as blind people.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oral and dental health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The researcher visits the selected schools at a specific time and with prior coordination and provides the parental consent form to the school principal to be sent and completed by the parents. After completing the parental consent forms, students who have the completed parental consent form will be included in the study. It should be noted that since the target group is elementary school students, verbal consent will be obtained from them to participate in the study. The educational program includes 4 sessions for students and 1 session for parents and teachers of the students, and each session is implemented for 45 to 60 minutes for the intervention group. The educational content is provided based on reliable sources from the Isfahan Provincial Health Office and the Faculty of Dentistry. The educational content mainly includes familiarizing students with the mouth and tooth structure, the benefits and obstacles of observing oral and dental hygiene, creating a sense of self-efficacy, tooth cleaning behaviors, and the correct use of oral and dental cleaning tools. In fact, the educational content of the study is determined and adjusted in accordance with the structures of the Transtheoretical model and the results of the pre-test. Training is conducted in groups using a combination of lecture, question and answer, practical demonstration, individual statements, brainstorming, and group discussion methods in each training session. During training classes, media such as pamphlets (distributed to all attendees in the class for home study), books, posters, educational films, and photographs are used to enhance learning. Intervention 2: Control group: will not receive any educational intervention. The control group will not receive any educational intervention. The control group will have to wait to receive the intervention and, if the intervention has a positive result, will receive the written content of the educational sessions 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 is potentially shareable after de-identifying individuals.

When:
Start access after printing the results

To whom:
All people working in academic, scientific and industrial sectors are able to receive data.

Conditions:
1- Using information to conduct scientific and research studies 
2- Not changing information and observing ethical standards

Where to obtain:
1- Conductors and authors of the research project 2- Research vice-chancellor of the university and the relevant educational institution (Isfahan University of Medical Sciences). 
Ways of communication with the executors of the research project: 
1- Ms. Negin Akbarpour, address: Subsection11., Hakim nasrollah Ave., Shahreza., Isfahan, contact number: 09210430855, email address: neginakbarpoor79@gmail.com
2- Dr. Hossein Shahnazi, Address: Department of Health Education., Faculty of Health., Isfahan University of Medical Sciences., Hezar Jerib Street., Isfahan, contact number: 09133360148, email address: h_shahnazi@yahoo.com.

How to obtain:
After the person's request is made by calling or emailing the project organizers and checking the scientific and moral qualification of the applicant, the information will be provided to him in the shortest possible time.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negin Akbarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences., Hezar Jerib St., Shiraz Gate., Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>neginakbarpoor79@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negin Akbarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences., Hezar Jerib St., Shiraz Gate., Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>neginakbarpoor79@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being in the first three stages of preparation for change according to the transtheoretical model
Completing the informed consent form to participate in the study</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>13 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having underlying diseases according to the opinion of the dentist
Age below 11 years and above 13 years</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>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The researcher visits the selected schools at a specific time and with prior coordination and provides the parental consent form to the school principal to be sent and completed by the parents. After completing the parental consent forms, students who have the completed parental consent form will be included in the study. It should be noted that since the target group is elementary school students, verbal consent will be obtained from them to participate in the study. The educational program includes 4 sessions for students and 1 session for parents and teachers of the students, and each session is implemented for 45 to 60 minutes for the intervention group. The educational content is provided based on reliable sources from the Isfahan Provincial Health Office and the Faculty of Dentistry. The educational content mainly includes familiarizing students with the mouth and tooth structure, the benefits and obstacles of observing oral and dental hygiene, creating a sense of self-efficacy, tooth cleaning behaviors, and the correct use of oral and dental cleaning tools. In fact, the educational content of the study is determined and adjusted in accordance with the structures of the Transtheoretical model and the results of the pre-test. Training is conducted in groups using a combination of lecture, question and answer, practical demonstration, individual statements, brainstorming, and group discussion methods in each training session. During training classes, media such as pamphlets (distributed to all attendees in the class for home study), books, posters, educational films, and photographs are used to enhance learning.</i_keyword>
      <i_keyword>Control group: will not receive any educational intervention. The control group will not receive any educational intervention. The control group will have to wait to receive the intervention and, if the intervention has a positive result, will receive the written content of the educational sessions after the end of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy. Timepoint: Measuring self-efficacy at the beginning of the intervention (before the intervention), 2 and 6 months after the intervention. Method of measurement: Questionnaire created by a researcher to measure the constructs of the Transtheoretical model.</prim_outcome>
      <prim_outcome>Perceived benefits. Timepoint: Measuring perceived benefits at the beginning of the intervention (before the intervention), 2 and 6 months after the intervention. Method of measurement: Questionnaire created by a researcher to measure the constructs of the Transtheoretical model.</prim_outcome>
      <prim_outcome>Perceived barriers. Timepoint: Measuring perceived barriers at the beginning of the intervention (before the intervention), 2 and 6 months after the intervention. Method of measurement: Questionnaire created by a researcher to measure the constructs of the Transtheoretical model.</prim_outcome>
      <prim_outcome>Frequency of cleaning behavior. Timepoint: Measuring the frequency of cleaning behavior at the beginning of the intervention (before the start of the intervention), 2 and 6 months after the intervention. Method of measurement: Questionnaire created by a researcher to measure the constructs of the Transtheoretical model.</prim_outcome>
      <prim_outcome>The frequency of using each of the cleaning tools. Timepoint: Measuring the frequency of using each of the cleaning tools at the beginning of the intervention (before the intervention), 2 and 6 months after the intervention. Method of measurement: Questionnaire created by a researcher to measure the constructs of the Transtheoretical model.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of dental plaque based on the grouping of dental plaque index. Timepoint: Measurement of dental plaque at the beginning of the study (before the start of the intervention) and six months after the intervention. Method of measurement: Through a dentist's examination with direct observation and grouping based on dental plaque index.</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>2024-12-14</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences., Hezar Jerib Street., Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
