<?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>IRCT201109097497N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-19</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of relaxation on mother’s anxiety and maternal-fetal attachment</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the effect of relaxation on mother’s anxiety and maternal-fetal attachment in primiparous women with IVF</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7981</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Then, the mothers in the intervention group were divided into two 20-subject groups and participated in four 90-minute educational classes weekly held on Saturdays. It should be mentioned that the intervention group received relaxation training in addition to the routine pregnancy care. The intervention was performed as follows:&#13;
First session: anatomical, physiological, and hormonal changes during pregnancy, sperm and ovum, stages of IVF, physiology of fetal development, signs of anxiety, effects of anxiety on pregnancy, strategies for more adaptation with changes in pregnancy including appropriate nutrition, individual health, physical health, mental health, identification of methods for improving compatibility with changes in pregnancy such as relaxation, and effects of relaxation.&#13;
Second session: development of fetus in different months of pregnancy, nutrition during pregnancy, effect of healthy nutrition and pregnancy care on maternal and fetal health, effect of relaxation on reduction of anxiety, and effect of relaxation on mother and fetus' physical and mental health.&#13;
Third session: Signs of risk in pregnancy and ways to cope with them, and effect of relaxation on improvement of mother's sleeping and nutrition, maternal-fetal attachment, and fetal growth.&#13;
Fourth session: effect of relaxation on delivery process, necessity to perform relaxation during delivery, effect of relaxation on improvement after delivery, breastfeeding, and reduction of postpartum depression.&#13;
At the end of all the educational sessions, Benson's relaxation technique was performed. This technique is quite easy and safe and the mothers were reassured regarding its safety by a gynecologist. This method is very easy to learn and does not take more than 10-20 minutes to perform (from the tip of toes to forehead). Benson's relaxation technique can be done while lying down or sitting on the chair. In order to make sure that women did the relaxation technique at home, in addition to an educational CD, they were provided with a checklist to record their daily exercises. The mothers were required to perform the relaxation technique at least once a day. At the beginning of each educational session, the checklists were collected, the educational content of the previous session was reviewed, and the participants' questions were answered. The most important practical trainings included staying in a calm environment, mental preparation, passive attitude, staying in a comfortable status, relaxation of all body muscles from the sole of the foot towards the upper extremities (for 10-20 minutes), and slowly getting out of relaxation. Intervention 2: The control group only received the routine care.</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>Akbarzadeh Marzieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh School of Nursing and Midwifery-  Shiraz</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+7 1164744257</telephone>
        <email>akbarzadehmarzieh@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences - Shiraz, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Akbarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh School of Nursing and Midwifery-Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+7 1164744257</telephone>
        <email>Akbarzadehmarzieh @yahoo.com</email>
        <affiliation>Fatemeh School of Nursing and Midwifery- Shiraz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria of the study were  being primiparous; having used IVF to get pregnant;  being 18-40 years old; having at least middle school degree; gestational age of 32-35 weeks;  not having obstetric problems;  and singleton pregnancy.&#13;
 On the other hand, the exclusion criteria of the study were suffering from cardiovascular diseases or serious psychological disorders and having pregnancy complications such as bleeding;  diabetes; hypertension; and preterm labor</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40-F48</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neurotic, stress-related and somatoform disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Then, the mothers in the intervention group were divided into two 20-subject groups and participated in four 90-minute educational classes weekly held on Saturdays. It should be mentioned that the intervention group received relaxation training in addition to the routine pregnancy care. The intervention was performed as follows:&#13;
First session: anatomical, physiological, and hormonal changes during pregnancy, sperm and ovum, stages of IVF, physiology of fetal development, signs of anxiety, effects of anxiety on pregnancy, strategies for more adaptation with changes in pregnancy including appropriate nutrition, individual health, physical health, mental health, identification of methods for improving compatibility with changes in pregnancy such as relaxation, and effects of relaxation.&#13;
Second session: development of fetus in different months of pregnancy, nutrition during pregnancy, effect of healthy nutrition and pregnancy care on maternal and fetal health, effect of relaxation on reduction of anxiety, and effect of relaxation on mother and fetus' physical and mental health.&#13;
Third session: Signs of risk in pregnancy and ways to cope with them, and effect of relaxation on improvement of mother's sleeping and nutrition, maternal-fetal attachment, and fetal growth.&#13;
Fourth session: effect of relaxation on delivery process, necessity to perform relaxation during delivery, effect of relaxation on improvement after delivery, breastfeeding, and reduction of postpartum depression.&#13;
At the end of all the educational sessions, Benson's relaxation technique was performed. This technique is quite easy and safe and the mothers were reassured regarding its safety by a gynecologist. This method is very easy to learn and does not take more than 10-20 minutes to perform (from the tip of toes to forehead). Benson's relaxation technique can be done while lying down or sitting on the chair. In order to make sure that women did the relaxation technique at home, in addition to an educational CD, they were provided with a checklist to record their daily exercises. The mothers were required to perform the relaxation technique at least once a day. At the beginning of each educational session, the checklists were collected, the educational content of the previous session was reviewed, and the participants' questions were answered. The most important practical trainings included staying in a calm environment, mental preparation, passive attitude, staying in a comfortable status, relaxation of all body muscles from the sole of the foot towards the upper extremities (for 10-20 minutes), and slowly getting out of relaxation.</i_keyword>
      <i_keyword>The control group only received the routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Befor intervention and one month after intervention. Method of measurement: Spielberger's scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal-infantile attachment. Timepoint: Befor and one month after intervention. Method of measurement: Cranly's questionnaire.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-09-22</approval_date>
        <contact_name>Shiraz University of Medical Sciences, Shiraz, Iran</contact_name>
        <contact_address>Shiraz University of Medical Sciences, Shiraz, Iran Shiraz,  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
