<?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>IRCT20230826059260N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-09</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of psychological intervention based on mother's mindfulness on the feeling of decreased fetal movements in the third trimester of pregnancy, pregnancy outcomes and the number of referrals</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of mindfulness-based intervention on the feeling of decreased fetal movements in the third trimester of pregnancy outcomes and number of referrals in Niknafs maternity hospital in Rafsanjan in 2023.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72310</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Abnormal pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: The research population is pregnant women with decreased fetal movements in the gestational age range of 28-30 weeks who have visited Nik Nafs maternity hospital for the first time. After obtaining informed consent from the pregnant parents and if they meet the entry criteria, the pregnant mother will enter the study with the doctor's confirmation that there is no problem and the health of the fetus. The samples will be divided into two control and intervention groups. Pregnant women in the intervention group are immediately placed on the bed, undergoing individual psychological counseling based on mindfulness for 45 minutes. After discharge, once every three days and in 5 times, remote counseling is done, which includes three components: 1) a short phone call of 5 minutes 2) immediately after the phone call, audio files And a video is sent to women as a part of the consultation via WhatsApp, Telegram or Skype. 3) A pregnant woman can ask the counselor questions related to counseling and fetal movements in phone consultations and in between through WhatsApp, Telegram or Skype until the end of her pregnancy. Intervention 2: Control group:Control group: This group does not receive any counseling and only prenatal care is performed and is evaluated through a self-made questionnaire: fetal movements, pregnancy outcome and the number of referrals.</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:
Part of the information related to the main consequences is possible to share.

When:
The access period starts six months after the announcement of the results

To whom:
Academic and scientific institutions

Conditions:
To investigate additional research and other parameters

Where to obtain:
via email F_mirzaee@gmail.com

How to obtain:
The request should be sent via e-mail, and after checking and approval, it will be sent within a period of one month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Firozeh Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>F_mirzaee@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Firozeh Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>F_mirzaee@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age less than 35 years old
Absence of oligohydraminosis and polyhydraminosis
Absence of smoking and any opioids 
 Absence of anterior placenta
 Absence of SGA fetus
 Singleton pregnancy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to attend more than two sessions
 Participation in other counseling sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O36.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Maternal care for fetal problem, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: The research population is pregnant women with decreased fetal movements in the gestational age range of 28-30 weeks who have visited Nik Nafs maternity hospital for the first time. After obtaining informed consent from the pregnant parents and if they meet the entry criteria, the pregnant mother will enter the study with the doctor's confirmation that there is no problem and the health of the fetus. The samples will be divided into two control and intervention groups. Pregnant women in the intervention group are immediately placed on the bed, undergoing individual psychological counseling based on mindfulness for 45 minutes. After discharge, once every three days and in 5 times, remote counseling is done, which includes three components: 1) a short phone call of 5 minutes 2) immediately after the phone call, audio files And a video is sent to women as a part of the consultation via WhatsApp, Telegram or Skype. 3) A pregnant woman can ask the counselor questions related to counseling and fetal movements in phone consultations and in between through WhatsApp, Telegram or Skype until the end of her pregnancy.</i_keyword>
      <i_keyword>Control group:Control group: This group does not receive any counseling and only prenatal care is performed and is evaluated through a self-made questionnaire: fetal movements, pregnancy outcome and the number of referrals.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of visits to the mother due to the feeling of decreased fetal movements. Timepoint: Throughout pregnancy. Method of measurement: Self-made questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pregnancy outcomes include: Apgar &lt;7 in the first 5 minutes of birth, Apgar &lt;4 in the first 5 minutes of birth, birth weight less than 10%, birth weight &lt;2 SD, NICU admission, fetal death (stillbirth), premature delivery (less than 37 weeks), age Pregnancy at birth &gt; 6+41, spontaneous onset of labor, induction of labor, cesarean section. Timepoint: Postpartum. Method of measurement: Self-made 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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-01</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
