<?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>IRCT20230926059529N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-17</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the Effect of Educational Intervention on Cervical Cancer Knowledge</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Impact of the Educational Intervention on Knowledge, Perception and Screening of Cervical Cancer in Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72782</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Among the 3 comprehensive urban health service centers of Khash, one center will be selected as an intervention center and one as a control center by simple random. Then, 45 people from each of the centers will be randomly selected from the list of eligible women covered and entered into the study, Blinding description: In the said trial, all participants were blind and would not know how the groups were assigned. In such a way that the grouping of people will not be provided to them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cervical Cancer in Women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, educational content will be developed based on the guidelines of the Ministry of Health, reputable articles and books, and educational booklets. The topics of the training sessions include understanding cervical cancer, the importance of screening and self-care in prevention, addressing social misconceptions and dispelling taboos about cervical cancer. In this study, visual educational technologies such as films, photos, visual handouts, and interactive exercises will be utilized to allow participants to share their experiences and knowledge and learn from others through observation. The visual validity of the educational materials will be determined through a review by a ten-member panel consisting of experts such as doctors, nurses, health educators, and patients. The training sessions will be conducted by a health specialist at comprehensive health service centers. Each session is expected to last an average of 50-60 minutes, with a maximum of 15 participants in each group. At the beginning of the study, control group patients will receive four consecutive educational sessions over four days, followed by a one-hour session every three months until the end of the study for follow-up and reinforcement of preventive behaviors. In total, six educational sessions will be conducted throughout the study. Intervention 2: Control group: Control group: In the control group, there is no special intervention. The information of the people of this group, such as demographic data and specific data, will be archived after their identification, so that after the end of the educational intervention in the intervention group, it will be compared with the data found in the intervention group and used in the conclusion of the research.</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 participant data files will be shared after de-identification.
The study protocol will be fully shared.
The statistical analysis map will be fully shared.
The informed consent form will be fully shared.
The clinical study report will be fully shared.
The codes used in the analysis will be fully shared.
The data classification system will be fully shared.

When:
The start of the period of access to the study data will be approximately 6 months after the publication of the research results.

To whom:
The data of this research is only available for working and non-working researchers and students.

Conditions:
There are no special conditions.

Where to obtain:
Applicants can contact the researcher through the email address and request the data.
First e-mail address of the researcher (default):
osamakord0699@gmail.com
Second e-mail address of the researcher (only if the default e-mail is not available):
osamakord0699@outlook.com

How to obtain:
The data requester will receive a response within 3 business days after clearly presenting his request via email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Osama Kord</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sistan and Baluchistan province, Khash city, Central part, Akbarabad village</address>
        <city>Khash</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9885113136</zip>
        <telephone>+98 54 3376 0000</telephone>
        <email>osamakord0699@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Osama Kord</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sistan and Baluchistan province, Khash city, Central part, Akbarabad village</address>
        <city>Khash</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9885113136</zip>
        <telephone>+98 54 3376 0000</telephone>
        <email>osamakord0699@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All Women Aged 18 to 60 Referring to Health Centers in Khash City</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People who visit the base at a time other than what is predetermined.
People who have various mobility disabilities and cannot wait at the base.</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, educational content will be developed based on the guidelines of the Ministry of Health, reputable articles and books, and educational booklets. The topics of the training sessions include understanding cervical cancer, the importance of screening and self-care in prevention, addressing social misconceptions and dispelling taboos about cervical cancer. In this study, visual educational technologies such as films, photos, visual handouts, and interactive exercises will be utilized to allow participants to share their experiences and knowledge and learn from others through observation. The visual validity of the educational materials will be determined through a review by a ten-member panel consisting of experts such as doctors, nurses, health educators, and patients. The training sessions will be conducted by a health specialist at comprehensive health service centers. Each session is expected to last an average of 50-60 minutes, with a maximum of 15 participants in each group. At the beginning of the study, control group patients will receive four consecutive educational sessions over four days, followed by a one-hour session every three months until the end of the study for follow-up and reinforcement of preventive behaviors. In total, six educational sessions will be conducted throughout the study.</i_keyword>
      <i_keyword>Control group: Control group: In the control group, there is no special intervention. The information of the people of this group, such as demographic data and specific data, will be archived after their identification, so that after the end of the educational intervention in the intervention group, it will be compared with the data found in the intervention group and used in the conclusion of the research.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cervical cancer knowledge score in Alam et al.'s 2007 questionnaire. Timepoint: Calculate the knowledge score before and after the intervention. Method of measurement: Alam et al.'s 2007 questionnaire.</prim_outcome>
      <prim_outcome>Cervical cancer perception score in Alam et al.'s 2007 questionnaire. Timepoint: Calculate the perception score before and after the intervention. Method of measurement: Alam et al.'s 2007 questionnaire.</prim_outcome>
      <prim_outcome>Cervical cancer screening score in Alam et al.'s 2007 questionnaire. Timepoint: Calculate the screening score before and after the intervention. Method of measurement: Alam et al.'s 2007 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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-27</approval_date>
        <contact_name>Ethics committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Persian Gulf Blvd., Dr. Hasabi Square, University of Medical Sciences Campus, Central Headquarters Building, 2nd Floor Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
