<?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>IRCT2015112225182N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-05</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences. Deputy of Research and Technology</primary_sponsor>
      <public_title>The effect of educationalanti anxiety  protocol on pregnant  mothers anxiety and  maternal-newborn  attachment</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational anti anxiety  protocol  based on "Orem Self Care Model"on pregnant  mothers anxiety and  maternal-newborn  attachmen</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21094</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>Anxiety.</hc_freetext>
      <i_freetext>Self-care education program  is designed in the form of four 60-minute sessions  within 4 weeks in group discussion, questions and answers, presentation slides and broadcast film methods  for groups of 10-15 people in the training class center of Health held by the researcher &#13;
15 minutes of the end of each training session, stretching and breathing exercises and relaxation allocated.The intervention  group in addition, anti-anxiety Protocol based on Orem self care model  receive the central usual care as well as.  The group control only receive routine  prenatal care that includes weight control, blood pressure monitoring, listen to the heartbeat of a fetus, and pregnancy tests are routinely found in their centers by midwives respected.</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>Nahid Shakouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Deputy of Research and Technology, Mashhad University of Medical Sciences, Daneshgah St.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3843 3363</telephone>
        <email>ramresearch@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haji Mohammad Norozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing &amp; midwifery, Daneshgah St.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13944-91388</zip>
        <telephone>+98 51 3843 3363</telephone>
        <email>norozihm@mums.ac.ir; amresearch@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
1.	Iranian and Persian language and live in Mashhad. &#13;
2.	Muslim. &#13;
3.	phone back.&#13;
4.	at least be literate. &#13;
5.	age 18-35 years old,&#13;
6.	 gestational age based on LMP or sonography at  the first quarter 28-34 gestational week. &#13;
7.	lives with her husband and her husband's only wife. &#13;
8.	having mild to moderate score anxiety. &#13;
9.	obstetric complications in pregnancy is not present. (Hypertension, gestational diabetes, placenta previa, multiple pregnancies, oligohydramnios, pre-eclampsia and polyhydramnios) &#13;
10.	in the current pregnancy is not a medical problem. (Heart problems, diabetes, chronic hypertension, acute respiratory problems, kidney, thyroid disorders, epilepsy, anemia, sexually transmitted diseases, infectious, neurological, tuberculosis, human immunodeficiency virus, the virus of human T lymphocytes), &#13;
11.	members of a family don’t  have genetic abnormalities in the &#13;
12.	history of infertility no.&#13;
13.	 history of mental illness, depression and chronic anxiety medication because it has not.&#13;
14.	Mother is alive and healthy.&#13;
15.	  Informed consent to complete. &#13;
16.	Drug abuse, alcohol and smoking, such as cigarettes and hookah is not. &#13;
17.	pregnancy is wanted, is the first single.&#13;
18.	  In the field of medical science studying the uneducated or not. &#13;
19.	During the last 6 months of stress (serious illness or spouse, death of a family member, migration, severe economic conditions, big marital disputes, accident, burglary) is not.&#13;
Exclusion criteri:&#13;
1, use of certain medications effective on psychomotpr system during pregnancy by mother. (Imipramine, diazepam, amitriptyline, phenobarbital, carbamazepine, phenytoin and other drugs that affect mental) &#13;
2. Mother's unwillingness to continue cooperation in research.&#13;
3-evidence obstetric complications during pregnancy. (Vaginal bleeding, preterm labor, PROM) &#13;
4-occurrence of anxiety-causing agent or incident during pregnancy. (Death of close ones, spiritual crises, financial crises and divorce) &#13;
5- non-participation In the post-test. &#13;
6-- non-participation in more than one session of self-care classes.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F53.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified      Depression:</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Self-care education program  is designed in the form of four 60-minute sessions  within 4 weeks in group discussion, questions and answers, presentation slides and broadcast film methods  for groups of 10-15 people in the training class center of Health held by the researcher &#13;
15 minutes of the end of each training session, stretching and breathing exercises and relaxation allocated.The intervention  group in addition, anti-anxiety Protocol based on Orem self care model  receive the central usual care as well as.  The group control only receive routine  prenatal care that includes weight control, blood pressure monitoring, listen to the heartbeat of a fetus, and pregnancy tests are routinely found in their centers by midwives respected</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety of Pregnant mother. Timepoint: pre intervention &amp; 1 week after intervention. Method of measurement: Anxiety Inventory (STAI).</prim_outcome>
      <prim_outcome>Mother-infant attachment. Timepoint: 1-2 week after intervention. Method of measurement: check list assessment of mother-infant attachment Avant.</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>Mashhad University of Medical Sciences. Deputy of Research and Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-15</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad Iran Student Research Committee, Faculty of  Nursing@ midwifery Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
