<?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>IRCT2017061734592N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-09</date_registration>
      <primary_sponsor>School of Nursing and Midwifery</primary_sponsor>
      <public_title>The effect of invitro fertilization (IVF) mothers' preparation on maternal self-steem and stress</public_title>
      <acronym></acronym>
      <scientific_title>The effect of invitro fertilization (IVF) mothers'preparation for maternal role playing on maternal self-steem and stress</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26399</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>invitro fertilization (IVF) mothers.</hc_freetext>
      <i_freetext>Intervention 1: The content of the mother's preparation program to play mothering role in optimal way and investigating its effect on maternal stress and self-esteem, will include maternal care during pregnancy (nutrition, sleeping rate and rest, exercise and body condition correction), ways to control of mother's stress, training on the stages of development and growing of the fetus and the baby, attachment to the fetus, preparation for delivery and caretaking baby, relationship with the husband during pregnancy and after delivery, self-care during pregnancy and after delivery. Additionally, the evaluation needs form of educations for pregnancy period will be given to mothers by the researcher to review and resolve other educational needs of mothers. This content will be given to mothers after a complete overview of valid articles and resources, in addition to attending training in preparation sessions in the form of educational pamphlets. The number of sessions will be 4 sessions of 2 hours for 4 weeks in this study due to the effectiveness of the number of mother's preparation sessions on mother's stress in the paper by Pouafshar et al. (2005), with the title of the effect of delivery preparation training on stress during pregnancy and delivery in first pregnant women referring to social security clinics in Mashhad. At first, information collecting tools including demographic questionnaire, Pregnancy's Worries and Stress Questionnaire, and Maternal Self-Report Inventory for maternal self-esteem are provided to the mothers of the two groups and they are asked to complete the questionnaires after obtaining informed consent. The contents regarding the goals of the preparation program, maternal care during pregnancy (nutrition, sleeping rate and rest, exercise and physical situation correction) control the mother's stress and relaxation will be thought at the first session of the preparation program, relaxation will be exercised at the end of the session slowly and  mothers are asked to write down the frequency of relaxation, the purpose of writing the frequency of relaxation performed by the mother is to increase attention and to remind this matter to mother at home. The second session will include the presentation of contents about fetus growing and development, attachment to the fetus, and education of fetus attachment enhancement behaviors. At the end of the session, mothers will be asked to write the times of talking with the fetus, calling the fetus and touching the abdomen to feel the emotions of the fetus's motions, the purpose of writing the frequency of doing attachment behaviors by mother is to increase attention and to remind this matter to the mother at home. Educational contents for the third session include explanations about the preparation for delivery, baby take caring, infant's developmental stages and attachment to the baby, the sense of completeness of the mother is facilitated by learning how to care for the infant and how to understand his/her reactions and respond appropriately to them, such as calming down the infant in crying time. At the fourth session, contents will be provided about relationship with husband during pregnancy and after delivery, self-take caring during pregnancy and after delivery. Sessions will be face-to-face education in groups of up to 5-6 people using PowerPoint, speech and questions and answers, and educational pamphlets will be given to mothers. The probable questions of the mothers will be answered at the end of each session. Information from the mothers of the test group will be collected and compared immediately after the end of the fourth session and four weeks after the intervention. The samples are free in responsive to the questionnaire and the information is recorded and kept confidential. The researcher will be available at the time of completing the tools to answer any probable questions. Intervention 2: The samples are contacted by the phone and made an appointment with them after assigning 30 mothers to the control group. At first, information collecting tools including demographic questionnaire, Pregnancy's Worries and Stress Questionnaire, and Maternal Self-Report Inventory for maternal self-esteem are provided to the mothers of the two groups and they were asked to complete the questionnaires after obtaining informed consent. Information from the mothers of the test group will be collected and compared again immediately after the end of the fourth session and four weeks after the completing the primary questionnaire. It should be noted that in order to observe ethics in the research, educational content will be given to mothers of the control group as educational pamphlets after completing the final questionnaires.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefe Salimi Akin Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 88 6553 6671</telephone>
        <email>atefe-salimi@sbmu.ac.iratefe.salimi@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefe Salimi Akin Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 88 6553 6671</telephone>
        <email>atefe-salimi@sbmu.ac.iratefe.salimi@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for the study: fertile women treated with assisted reproductive techniques in vitro fertilization (IVF), gestational age between 12 weeks to the end of 20 weeks, history of least 2 years of infertility and no history of mental illness.&#13;
&#13;
Exclusion criteria from the study: mothers fertilized with other methods of assisted reproductive technology, secondary infertility,  gestational age less than 12 weeks and more than 20 weeks,history of infertility less than 2 years, a history of mental illness, mothers who have Preterm delivery</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z31.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>In vitro fertilization</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The content of the mother's preparation program to play mothering role in optimal way and investigating its effect on maternal stress and self-esteem, will include maternal care during pregnancy (nutrition, sleeping rate and rest, exercise and body condition correction), ways to control of mother's stress, training on the stages of development and growing of the fetus and the baby, attachment to the fetus, preparation for delivery and caretaking baby, relationship with the husband during pregnancy and after delivery, self-care during pregnancy and after delivery. Additionally, the evaluation needs form of educations for pregnancy period will be given to mothers by the researcher to review and resolve other educational needs of mothers. This content will be given to mothers after a complete overview of valid articles and resources, in addition to attending training in preparation sessions in the form of educational pamphlets. The number of sessions will be 4 sessions of 2 hours for 4 weeks in this study due to the effectiveness of the number of mother's preparation sessions on mother's stress in the paper by Pouafshar et al. (2005), with the title of the effect of delivery preparation training on stress during pregnancy and delivery in first pregnant women referring to social security clinics in Mashhad. At first, information collecting tools including demographic questionnaire, Pregnancy's Worries and Stress Questionnaire, and Maternal Self-Report Inventory for maternal self-esteem are provided to the mothers of the two groups and they are asked to complete the questionnaires after obtaining informed consent. The contents regarding the goals of the preparation program, maternal care during pregnancy (nutrition, sleeping rate and rest, exercise and physical situation correction) control the mother's stress and relaxation will be thought at the first session of the preparation program, relaxation will be exercised at the end of the session slowly and  mothers are asked to write down the frequency of relaxation, the purpose of writing the frequency of relaxation performed by the mother is to increase attention and to remind this matter to mother at home. The second session will include the presentation of contents about fetus growing and development, attachment to the fetus, and education of fetus attachment enhancement behaviors. At the end of the session, mothers will be asked to write the times of talking with the fetus, calling the fetus and touching the abdomen to feel the emotions of the fetus's motions, the purpose of writing the frequency of doing attachment behaviors by mother is to increase attention and to remind this matter to the mother at home. Educational contents for the third session include explanations about the preparation for delivery, baby take caring, infant's developmental stages and attachment to the baby, the sense of completeness of the mother is facilitated by learning how to care for the infant and how to understand his/her reactions and respond appropriately to them, such as calming down the infant in crying time. At the fourth session, contents will be provided about relationship with husband during pregnancy and after delivery, self-take caring during pregnancy and after delivery. Sessions will be face-to-face education in groups of up to 5-6 people using PowerPoint, speech and questions and answers, and educational pamphlets will be given to mothers. The probable questions of the mothers will be answered at the end of each session. Information from the mothers of the test group will be collected and compared immediately after the end of the fourth session and four weeks after the intervention. The samples are free in responsive to the questionnaire and the information is recorded and kept confidential. The researcher will be available at the time of completing the tools to answer any probable questions.</i_keyword>
      <i_keyword>The samples are contacted by the phone and made an appointment with them after assigning 30 mothers to the control group. At first, information collecting tools including demographic questionnaire, Pregnancy's Worries and Stress Questionnaire, and Maternal Self-Report Inventory for maternal self-esteem are provided to the mothers of the two groups and they were asked to complete the questionnaires after obtaining informed consent. Information from the mothers of the test group will be collected and compared again immediately after the end of the fourth session and four weeks after the completing the primary questionnaire. It should be noted that in order to observe ethics in the research, educational content will be given to mothers of the control group as educational pamphlets after completing the final questionnaires.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal Self Steem. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Maternal Self-Report Inventory-Short Version.</prim_outcome>
      <prim_outcome>Maternal stress. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Inventory of stress and worry of pregnancy.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shahid Beheshti University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>School of Nursing and Midwifery</source_name>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-24</approval_date>
        <contact_name>Shahid Beheshti University of Medical Sciences, school of nursing and midwifery</contact_name>
        <contact_address>school of nursing and midwifery,  Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
