<?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>IRCT20231130060228N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-19</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>Comparison of Two Educational Intervention Methods With Mobile Application vs. Face-to-Face Instruction on Knowledge, Attitude, Practice, Perceived Self-Efficacy, and Adherence with Pap Smear Testing among Women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Two Educational Intervention Methods With Mobile Application vs. Face-to-Face Instruction on Knowledge, Attitude, Practice, Perceived Self-Efficacy, and Adherence with Pap Smear Testing among Women Aged 30-59</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74165</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A list of individuals who have achieved poor and average knowledge scores will be compiled. These individuals will be numbered consecutively for random assignment to one of three groups: A, B, or C. This study will involve 120 participants. The method of permutation blocks will be employed for this purpose. We will utilize Random Allocation Software, which will be used to create 20 blocks of six. This software aids in balancing the number of samples allocated to each group under study. This feature is particularly beneficial when intermediate analyses are required during the sampling process, as it ensures an equal number of samples in each group. In this study, the blocking type is consistent across all blocks. Out of the total 120 participants, groups A (control group), B (intervention group receiving face-to-face training), and C (intervention group receiving training via a mobile phone application) will each be assigned 40 participants. Upon selection of the samples, they will be contacted. A brief overview of the study, its objectives, the teaching method, and the criteria for inclusion and exclusion from the study will be provided. If they are willing to participate, they will be included in the study. If they decline, the next individual will be contacted. Written consent will be obtained from all participants agreeing to participate in the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cervical Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first group of the intervention will be in such a way that at first the participants will be members of the ITA group. After welcoming and introducing himself, the researcher will again remind the objectives of the research, the research team, the duration of training in this group and the timing of completing the questionnaire; Then the time and place of the first training session was announced in the groupThe schedule of training sessions will be in person one day a week. These sessions include 2 training sessions to increase members' knowledge in the field of knowledge, 2 training sessions to improve women's attitudes and beliefs regarding Pap smear testing, 2 training sessions aimed at improving women's self-efficacy regarding Pap smear testing, and 1 A training session will be held with the aim of improving the performance of women regarding the Pap smear test and 1 training session will be held regarding the improvement of compliance to the Pap smear test. After 4 weeks have passed since the beginning of the training. The post-examination process will be immediate, one month and three months later. Intervention 2: Intervention group: In the second group, the intervention will be in the form that at first the participants will be members of the ITA group. After welcoming and introducing himself, the researcher will again remind the objectives of the research, the research team in this group and the schedule for completing the questionnaire, then the link to the mobile application. will be sent to them for installation. After 4 weeks from the beginning of the training. The post-test process was immediate, one month and three months later. The measurement and evaluation tools will be the same in all stages before and after the intervention. Intervention 3: Control group: After evaluating and comparing two educational interventions, the control group will also receive the desired intervention based on ethical principles.</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:
Part of the data related to the main outcomes can be shared

When:
The access period starts 6 months after the results are published

To whom:
The data will be made available only to researchers working in academic and scientific institutions

Conditions:
Repeated measures analysis to investigate the effect of training persistence 6 months after the last intervention

Where to obtain:
By sending an email to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir

How to obtain:
One week after sending the email from the requester to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir, a reply will be given.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medical Sciences, Tarbiat Modares University, Jalal Al Ahmad Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115111</zip>
        <telephone>+98 21 8288 4546</telephone>
        <email>f.zarei@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medical Sciences, Tarbiat Modares University, Jalal Al Ahmad Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115111</zip>
        <telephone>+98 21 8288 4546</telephone>
        <email>f.zarei@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. A resident of Saveh city
Covered by the centers and has an active electronic file of the Sib system
Age between 30 and 59 years
Having marriage experience
More than 3 years have passed since the first sex
Obtaining a weak and average knowledge score in the first stage of study
Using a smart mobile phone to use virtual networks (ITA)
Desire to participate in research</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>59 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1. Participation in another educational program at the same time or parallel to the intervention
Being pregnant now
Perform hysterectomy
Genital warts or cervical cancer known and under treatment
Conducting a pap smear test in the last 2 years
Conducting HPV screening tests in the last 10 years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C53.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of cervix uteri, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first group of the intervention will be in such a way that at first the participants will be members of the ITA group. After welcoming and introducing himself, the researcher will again remind the objectives of the research, the research team, the duration of training in this group and the timing of completing the questionnaire; Then the time and place of the first training session was announced in the groupThe schedule of training sessions will be in person one day a week. These sessions include 2 training sessions to increase members' knowledge in the field of knowledge, 2 training sessions to improve women's attitudes and beliefs regarding Pap smear testing, 2 training sessions aimed at improving women's self-efficacy regarding Pap smear testing, and 1 A training session will be held with the aim of improving the performance of women regarding the Pap smear test and 1 training session will be held regarding the improvement of compliance to the Pap smear test. After 4 weeks have passed since the beginning of the training. The post-examination process will be immediate, one month and three months later.</i_keyword>
      <i_keyword>Intervention group: In the second group, the intervention will be in the form that at first the participants will be members of the ITA group. After welcoming and introducing himself, the researcher will again remind the objectives of the research, the research team in this group and the schedule for completing the questionnaire, then the link to the mobile application. will be sent to them for installation. After 4 weeks from the beginning of the training. The post-test process was immediate, one month and three months later. The measurement and evaluation tools will be the same in all stages before and after the intervention</i_keyword>
      <i_keyword>Control group: After evaluating and comparing two educational interventions, the control group will also receive the desired intervention based on ethical principles.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge score in the Farsi version of cervical cancer screening self-efficacy questionnaire. Timepoint: Before the intervention, immediately, one month later and three months after the intervention. Method of measurement: Persian version of cervical cancer screening self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Attitude score in the Persian version of cervical cancer screening self-efficacy questionnaire. Timepoint: Before the intervention, immediately, one month later and three months after the intervention. Method of measurement: Persian version of cervical cancer screening self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy score in the Farsi version of cervical cancer screening self-efficacy scale. Timepoint: Before the intervention, immediately, one month later and three months after the intervention. Method of measurement: Persian version of cervical cancer screening self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Practice score in the Farsi version of cervical cancer screening self-efficacy questionnaire. Timepoint: Before the intervention, immediately, one month later and three months after the intervention. Method of measurement: Persian version of cervical cancer screening self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Adhereance to action score in Persian version of the Adhereance to action pap smear. Timepoint: Before the intervention, immediately, one month later and three months after the intervention. Method of measurement: Persian version of the Adhereance to action pap smear.</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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-18</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modares University</contact_name>
        <contact_address>Jalal Al Ahmad Street, Nasr Bridge, Tarbiat Modares University, Faculty of Medicine Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
