<?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>IRCT20180112038324N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-10</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Maternal  Fetal  Attachment</public_title>
      <acronym>MFA</acronym>
      <scientific_title>The  Effect  of  Fetal  Movement Counting on Maternal  Fetal  Attachment  in  Primiparous  Women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28922</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: People in the intervention group should lie down to the left side to count the movements of the fetus by putting hands on the abdomen and feeling the movement of the fetus, and every day it will be recorded in a special form.This should be done for two weeks consecutively.Then, for each day, put a knot on the ribbon, Blinding description: In this study, clinical caregivers, researcher and  the analyst were not kept blin.Only the participants were kept blind.To avoid bias,odd days were assigned to the control group and only completed the questionnaires and
received routine care.Couple days were assigned to the intervention group. 
 Except completion of questionnaires, they received an intervention that included counting the movements of the fetus and recording it.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The Effect of Fetal Movement Counting on Maternal Fetal Attachment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, the Cranley's maternal fetal attachment questionnaire(MFAS) is completed before intervention.Then, counts of the movements of the fetus are taught to the mother by placing hands on the abdomen and paying attention to the movements of the fetus and counting it is done. Mothers count the movements of the fetus for two weeks each day and the number of it is recorded on the special form. For each day, just one knot is tied to the ribbon. After two weeks the special form and ribbon is delivered from the people and again, the MFAS questionnaire is completed by them. Intervention 2: Control group:No training is given in this group. Only routine care is taken. Once at the beginning of the study, the MFAS questionnaire is completed by this group. Then, after two weeks and at the end of the study, the MFAS questionnaire was completed by the people of this group again.Data are analyzed before and after the intervention by SPSS software.</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:
All data is shairable after unidentifiable people.

When:
Three months after printing results.

To whom:
For all researchers in medical sciences.

Conditions:
Data, for any scientific research by referring to the above research can be used through valid sites.

Where to obtain:
To the responsible email address of the author
Mobile Number: 0098 9144475179 Name: Sima Faraji.

How to obtain:
A week after the call and correspondence via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sima Faraji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1st Floor, Unit One, Shams Apartment, Alley4, Next To Gaz Company, Molavi Street.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5719996785</zip>
        <telephone>+98 44 3348 5014</telephone>
        <email>faraji.s@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sima Faraji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1st Floor, Unit One, Shams Apartment, Alley4, Next To Gaz Company, Molavi Street.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5719996785</zip>
        <telephone>+98 44 3348 5014</telephone>
        <email>faraji.s@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having ages of 18-35 years
Having at least elementary education
Familiarity with Persian and Turkish
Iranian nationality
The first Pregnancy
Not having a history of abortion and infertility
Singleton pregnancy
Gastational age of between 28-34 weeks
Gain score less than 22 from general health questionnaireGHQ28
Not having vaginal bleeding during pregnancy
Not having blood pressure in pregnancy
Not having heart disease and diabetes
Not having substance abuse and smoking
Not having a history of death for the loved ones in the last six months
Not having a history of mental disorders
Wanted pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Vaginal bleeding
Having chronic blood pressure
Multiparous women
Multipel pregnancy
Intra uterin growth retardation
Surgical history
Pregnant less than 28 weeks
Pregnant more than 34 weeks
Primigravid less than 18 years old
Primigravid more than 35 years old</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, the Cranley's maternal fetal attachment questionnaire(MFAS) is completed before intervention.Then, counts of the movements of the fetus are taught to the mother by placing hands on the abdomen and paying attention to the movements of the fetus and counting it is done. Mothers count the movements of the fetus for two weeks each day and the number of it is recorded on the special form. For each day, just one knot is tied to the ribbon. After two weeks the special form and ribbon is delivered from the people and again, the MFAS questionnaire is completed by them.</i_keyword>
      <i_keyword>Control group:No training is given in this group. Only routine care is taken. Once at the beginning of the study, the MFAS questionnaire is completed by this group. Then, after two weeks and at the end of the study, the MFAS questionnaire was completed by the people of this group again.Data are analyzed before and after the intervention by SPSS software.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal Fetal Attachment. Timepoint: Before and after the intervention. Method of measurement: Cranley's Maternal Fetal Attachment Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Counting Fetal Movements. Timepoint: After the intervention. Method of measurement: Putting hands on the abdomen and counting the number of fetal movements.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-28</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>1st Floor, Unit One, Shams Apartment, Alley4, Next to Gaz Compani, Molavi Street. Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
