<?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>IRCT20210315050716N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-28</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of intervention based on 5 A's self-management model on the promotion of behaviors related to women's reproductive health after legal abortion</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of intervention based on 5 A's self-management model on the promotion of behaviors related to women's reproductive health after legal abortion</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55184</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Individuals are randomly divided into two groups based on a simple randomization method using a random number table. To use a table of random numbers, the researcher must first preset the direction in which to read the numbers (for example, up, down, left or right), the researcher then touches one of the numbers and moves in one of the predetermined directions (in this study, the right direction is selected) and records the numbers. In this way, numbers between 01 and 72 are obtained, the first 36 numbers are divided into the intervention group and the next 36 numbers into the control group. Individuals are placed in the intervention or control group according to their number matching, respectively, when they enter the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Legal abortion, Promote reproductive health.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will undergo an intervention based on the 5 A`s self-management model, which will be implemented in five stages. 1. Assess phase: This phase will be performed in the hospital after therapeutic abortion and before discharge from the hospital and includes assess and recognition of problems, knowledge, behaviors and beliefs related to sexual and reproductive health after abortion. At this stage, the patient at the time of admission examined for history and cause of medical abortion (maternal disease or fetal disease), the patient's ability and desire to adopt the necessary behaviors immediately after abortion in terms of complications and problems after abortion, including bleeding, infection and pain, genital hygiene and prevention of sexually transmitted infections, sexual function and family planning, and self-management of reproductive health-related behaviors through face-to-face interviews and completing a researcher-made reproductive health-related behavioral questionnaire. 2. Advise stage: This stage is also done in the hospital. At this stage, according to the results of the previous stage, health risks and required training in the field of reproductive health are identified and counseling is provided by providing specific information in a way that is understandable to the patient and individually, so that make relevant skills and behaviors relate self-management to sexual and reproductive health status and at this stage the benefits of changing behavior are emphasized.3. Agree stage: The stage of setting goals with the patient's consent. According to the identified problems, appropriate behavioral goals and agreement with the patient about his performance in the field of reproductive health are planned and an agreement on goals is determined according to the existing obstacles and problems as well as the interests and priorities of samples and their desire and ability to changing behavior in the field of reproductive and sexual health and a practical plan is designed for each of the goals. Three stages (Assess, Advise, Agree) will be performed in the hospital after abortion and after stabilization of the patient's condition. 4. Assist stage: This stage is done one week after the third stage. Samples will be given the necessary training in two-hour training sessions, that each session lasts two hours (one session per week) in groups of 6 on sexual health and prevention of sexually transmitted infections, normal and satisfactory sexual function, and family planning. And the educational booklet containing the above information will be provided to the research units. It should be noted that due to the corona epidemic conditions, if it is not possible to participate in groups of 6 people, training is done individually and face to face. The researcher then establishes continuous communication with the research units by telephone and based on the behavioral goals agreed with the research units, personal barriers to achieving the goals are re-examined and the necessary advice is given. And if there is a need for expert advice, a referral will be made based on it. It should be noted that the researcher will be responsible for the transportation costs of the research units. 5. Arrange stage: In this stage, patients' performance is followed, in fact, to ensure the implementation of practical programs by patients, follow-up for 2 weeks daily and then twice a week by phone call at the end of the period to check the implementation of the practical plan and the agreed behavioral goals. In addition, the patient's progress and success in performing behaviors related to reproductive health and his need for referral should be evaluated so that if there is a need to change the goals or practical plan, the necessary changes will be made by re-agreement and, if necessary, The patient needs to be given the necessary advice during the follow-up phase. The researcher will provide the intervention group with a telephone number for a 24-hour response to resolve possible problems of research units. Intervention 2: The control group will receive routine post-abortion care (Includes bleeding checks and vital signs and medication if prescribed by a doctor) at the hospital.  After the post-test, the educational content will be provided to the control group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mahshid Abdi Shahshahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, School of Nursing and Midwifery, Department of Midwifery and Reproductive Health</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>37927571</telephone>
        <email>m_abdi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahshid Abdi Shahshahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Department of Midwifery and Reproductive Health</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>37927571</telephone>
        <email>m_abdi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women of reproductive age who have had a medical abortion based on a legal abortion permit issued by the Isfahan Forensic Medicine Center.
Women of reproductive age who are interested to participate in this research project and have consent to participate in the study
Have a minimum literacy
Not participating in another clinical trial study similar to the present study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>having any known psychological problems such as anxiety and depression that are questioned by the self-reported method of the research units</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z30.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for general counseling and advice on contraception</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will undergo an intervention based on the 5 A`s self-management model, which will be implemented in five stages. 1. Assess phase: This phase will be performed in the hospital after therapeutic abortion and before discharge from the hospital and includes assess and recognition of problems, knowledge, behaviors and beliefs related to sexual and reproductive health after abortion. At this stage, the patient at the time of admission examined for history and cause of medical abortion (maternal disease or fetal disease), the patient's ability and desire to adopt the necessary behaviors immediately after abortion in terms of complications and problems after abortion, including bleeding, infection and pain, genital hygiene and prevention of sexually transmitted infections, sexual function and family planning, and self-management of reproductive health-related behaviors through face-to-face interviews and completing a researcher-made reproductive health-related behavioral questionnaire. 2. Advise stage: This stage is also done in the hospital. At this stage, according to the results of the previous stage, health risks and required training in the field of reproductive health are identified and counseling is provided by providing specific information in a way that is understandable to the patient and individually, so that make relevant skills and behaviors relate self-management to sexual and reproductive health status and at this stage the benefits of changing behavior are emphasized.3. Agree stage: The stage of setting goals with the patient's consent. According to the identified problems, appropriate behavioral goals and agreement with the patient about his performance in the field of reproductive health are planned and an agreement on goals is determined according to the existing obstacles and problems as well as the interests and priorities of samples and their desire and ability to changing behavior in the field of reproductive and sexual health and a practical plan is designed for each of the goals. Three stages (Assess, Advise, Agree) will be performed in the hospital after abortion and after stabilization of the patient's condition. 4. Assist stage: This stage is done one week after the third stage. Samples will be given the necessary training in two-hour training sessions, that each session lasts two hours (one session per week) in groups of 6 on sexual health and prevention of sexually transmitted infections, normal and satisfactory sexual function, and family planning. And the educational booklet containing the above information will be provided to the research units. It should be noted that due to the corona epidemic conditions, if it is not possible to participate in groups of 6 people, training is done individually and face to face. The researcher then establishes continuous communication with the research units by telephone and based on the behavioral goals agreed with the research units, personal barriers to achieving the goals are re-examined and the necessary advice is given. And if there is a need for expert advice, a referral will be made based on it. It should be noted that the researcher will be responsible for the transportation costs of the research units. 5. Arrange stage: In this stage, patients' performance is followed, in fact, to ensure the implementation of practical programs by patients, follow-up for 2 weeks daily and then twice a week by phone call at the end of the period to check the implementation of the practical plan and the agreed behavioral goals. In addition, the patient's progress and success in performing behaviors related to reproductive health and his need for referral should be evaluated so that if there is a need to change the goals or practical plan, the necessary changes will be made by re-agreement and, if necessary, The patient needs to be given the necessary advice during the follow-up phase. The researcher will provide the intervention group with a telephone number for a 24-hour response to resolve possible problems of research units.</i_keyword>
      <i_keyword>The control group will receive routine post-abortion care (Includes bleeding checks and vital signs and medication if prescribed by a doctor) at the hospital.  After the post-test, the educational content will be provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of behaviors related to women's reproductive health. Timepoint: Before and two months after start of the intervention. Method of measurement: researcher-made questionnaire of measuring behaviors related to women's reproductive health.</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>2021-03-15</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology - Isfahan University of Medical Sciences isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
