<?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>IRCT20210604051490N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-04</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effect of educational program on Pap smear</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of educational program on Pap smear in women aged 18-70 referring to health centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65259</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The evaluation of the effectiveness of the educational intervention is based on the researcher's questionnaire, whose validity and reliability have been confirmed, Randomization description: Among the 5 headquarters centers of Mashhad city, two centers will be selected by cluster method, and then two centers will be randomly selected from the health centers covered by each headquarters center. Then, based on the information available in the SINA system, a list of eligible samples will be prepared in each health center and if they wish to participate in the research, they will be divided into two control and intervention groups based on a random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cervical cancer screening behavior.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group in this study includes 40 people. The intervention in this study will be educational. Before the start of the training, the questionnaire made by the researcher "compliance with pap smear" (which validity and reliability has been confirmed) will be completed by the participants and their points will be calculated. It should be noted that these people are randomly placed in the intervention group. Then, the educational content including a brief description of the reproductive system and the causes of cervical cancer, symptoms and complications of the disease, ways of prevention, introduction of pap smear and its importance, will be presented during 4 educational sessions in the form of lectures, film and slide shows, and group discussions. became. With the formation of the WhatsApp group, the process of communication with participants and questions and answers will continue. After the completion of 4 training sessions, the approximate duration of which is 45 minutes, immediately and three months later, the questionnaire will be completed and scored again, and the behavior of Pap smear will be checked. Intervention 2: Control group: The control group in this intervention consists of 40 people who are randomly placed in the control group after the pre-test and calculation of each person's score. There will be no intervention for the control group. Then the test will be taken using a questionnaire and the scores before and after will be compared. This post-test will be repeated immediately and 3 months after the end of the training for both groups under 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:
In this study, data can be shared after de-identifying individuals.

When:
Access starts 6 months after results are published

To whom:
Study documentation will be available for researchers working in academic and scientific institutions.

Conditions:
By mentioning the reason for using the documents, the issue will be raised and decided in a meeting with the project colleagues.

Where to obtain:
Mohammad Vahedian Shahroodi  vahedianm@mums.ac.ir
Shariati Sarcheshme Mansoore  shariatism971@mums.ac.ir

How to obtain:
1-Official request for necessary documentation and reason for it via university email
2- Application plan in the group of colleagues
3- Sending documents in case of confirmation of the identity of the sender and confirmation of colleagues within a period of one month

Comments:
The details of the data and information are not provided to people and only  general results are sent.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Vahidian Shahroudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Health collogue, Daneshgah 18, Daneshgah street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137673119</zip>
        <telephone>+98 51 3189 2202</telephone>
        <email>Vahedianm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Vahidian Shahroudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Health collogue- Daneshgah 18, Daneshgah street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137673119</zip>
        <telephone>+98 51 3189 2202</telephone>
        <email>Vahedianm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>be Iranian
At least have completed elementary education.
She has been married at least once (regardless of her current marital status)
At least three years have passed since the beginning of sex
Willingness to participate in the research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Refusal to participate in research
Cervical cancer or other sexually transmitted diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C53</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of cervix uteri</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group in this study includes 40 people. The intervention in this study will be educational. Before the start of the training, the questionnaire made by the researcher "compliance with pap smear" (which validity and reliability has been confirmed) will be completed by the participants and their points will be calculated. It should be noted that these people are randomly placed in the intervention group. Then, the educational content including a brief description of the reproductive system and the causes of cervical cancer, symptoms and complications of the disease, ways of prevention, introduction of pap smear and its importance, will be presented during 4 educational sessions in the form of lectures, film and slide shows, and group discussions. became. With the formation of the WhatsApp group, the process of communication with participants and questions and answers will continue. After the completion of 4 training sessions, the approximate duration of which is 45 minutes, immediately and three months later, the questionnaire will be completed and scored again, and the behavior of Pap smear will be checked.</i_keyword>
      <i_keyword>Control group: The control group in this intervention consists of 40 people who are randomly placed in the control group after the pre-test and calculation of each person's score. There will be no intervention for the control group. Then the test will be taken using a questionnaire and the scores before and after will be compared. This post-test will be repeated immediately and 3 months after the end of the training for both groups under study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cervical cancer screening (Pap smear). Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-15</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Health college, Daneshgah 18, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
