<?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>IRCT20210221050437N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-28</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>"The effect of midwifery counseling in Gamble's method on the women's self-efficacy and their coping with first abortion"</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of midwifery counseling based on Gamble approach on coping strategies and self-efficacy of women with the first abortion</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54591</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The randomization method was done using the website https://www.sealedenvelope.com, so that the samples are identified by block randomization method with 4 blocks and using random numbers table of under the web (online randomization). The control group was randomly assigned with the letter A and the intervention group with the letter B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Abortion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Self-efficacy and coping strategies questionnaires will be administered to patients within 72 hours after first abortion and then they will undergo midwifery counseling by Gamble's method. Gamble counseling strategy includes: Therapeutic connection between midwife and woman,accept and work with women’s perceptions,support the expression of feelings, filling in the missing pieces,connect the event with emotions and behaviors,review the abortion management,enhance social support,Reinforce positive approaches to coping and explore solutions.             Intervention group undergo counseling in two 45-75 minutes sessions.The first session is done in person during the first 72 hours and the second session is done by phone 4-6 weeks after the abortion. After one month, patients will undergo counseling by telephone and will fill the self-efficacy and coping strategies questionnaires through online platforms. These questionnaires will be filled again two months after the second counseling session for the third time, through online platforms. Patients in intervention group will receive educations upon breast examination and necessity of pap smear test within 72 hours, one month and three months after the first abortion. Intervention 2: Control group: Patients in control group will receive educations upon breast examination and necessity of pap smear test within 72 hours, one month and three months after the first abortion.</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:
Information about the main outcome is shared

When:
Access period starts 6 months after the results are published

To whom:
Researchers, midwives, doctors

Conditions:
Documentary researchers can be used for scientific advancement.
It is possible to access the data by sending an email to the supervisor.
Email: Shivakheirkhah1345@gmail.com

Where to obtain:
Scientific party of the study
Masoumeh Kheirkhah
Email:Shivakheirkhah1345@gmail.com
Mobile:09124787691

How to obtain:
After approval by the research assistant by email to the supervisor 
Email:Shivakheirkhah1345@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoume Kheirkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Rashid Yasmi St, Vanak Square, Valiasr St, Teheran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3186754384</zip>
        <telephone>+98 26 3330 8904</telephone>
        <email>Hasanzadefarzaneh1990@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Kheirkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Rashid Yasmi St, Vanak Square, Valiasr St, Teheran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3186754384</zip>
        <telephone>+98 912 478 7691</telephone>
        <email>shivakheirkhah1345@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with spontaneous abortion and therapeutic abortion
Taking no antidepressants or psychotropic drugs before and after abortion
No history of attending counseling classes, based on the patient's testimony
No experience of tragic event in the last 6 months, based on the patient's  testimony
Having a smartphone and messenger software and the ability to work with it
Living with spouse
Ability to read and write in Farsi
Iranian Nationality</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Attend any previous counseling sessions
History of infertility
History of repeated abortion
Suffering from any physical or mental illnesses predisposing to abortion</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spontaneous abortion</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Self-efficacy and coping strategies questionnaires will be administered to patients within 72 hours after first abortion and then they will undergo midwifery counseling by Gamble's method. Gamble counseling strategy includes: Therapeutic connection between midwife and woman,accept and work with women’s perceptions,support the expression of feelings, filling in the missing pieces,connect the event with emotions and behaviors,review the abortion management,enhance social support,Reinforce positive approaches to coping and explore solutions.             Intervention group undergo counseling in two 45-75 minutes sessions.The first session is done in person during the first 72 hours and the second session is done by phone 4-6 weeks after the abortion. After one month, patients will undergo counseling by telephone and will fill the self-efficacy and coping strategies questionnaires through online platforms. These questionnaires will be filled again two months after the second counseling session for the third time, through online platforms. Patients in intervention group will receive educations upon breast examination and necessity of pap smear test within 72 hours, one month and three months after the first abortion.</i_keyword>
      <i_keyword>Control group: Patients in control group will receive educations upon breast examination and necessity of pap smear test within 72 hours, one month and three months after the first abortion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coping strategies. Timepoint: During 72 hours after abortion up to 3 months after abortion. Method of measurement: Coping Inventory questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy. Timepoint: During 72 hours after abortion up to 3 months after abortion. Method of measurement: Schwartzer General Self-efficacy 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-08</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>No. 1, 2 Hades Alley, East 4th St, Eram Boul, Mehrshahr Karaj Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
