<?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>IRCT20200513047431N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-28</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of focused solution brief counseling on anxiety and labor pain intensity in nulliparous women</public_title>
      <acronym>SFBT</acronym>
      <scientific_title>The effectiveness of focused solution brief counseling on anxiety and labor pain intensity in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48167</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using the website https://www.sealedenvelope.com/simple-randomiser/v1/lists، and with the help of the methodological consultant ، the allocation sequence is generated. The 4-block method is used to create the allocation sequence. Within each block half of the intervention people and half as a control are considered. White envelopes are used to hide the sequence. In this way each sequence is placed inside a white envelope and the envelopes are placed side by side and envelopes are numbered. An envelope is opened for each person in the order in which they enter the study and assigned to the desired group. Participants are not blind because they are trained . After the intervention the questionnaires are completed by a person who is not aware of their group. The information analyst is also not aware of the  group of the people.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety and labor pain intensity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Perform short-term focus counseling  before labor pains begin،single session counseling is a solution oriented approach for mothers who have not attended childbirth preparation classes during pregnancy and they have anxiety.For the mothers of the intervention group in addition to the routine care of the ward the researcher conducts one session Solution Focused Brief counseling for 45 to 60 minutes ،it is done individually. Solution Focused Brief counseling is a strengths based model. With different techniques and reminders of exceptions ،it helps pregnant mothers to recognize their abilities and overcome their anxiety during childbirth. Techniques used: Immediate relaxation or abdominal breathing. Riding on the wave of terror. Education Autogenic. Technique Just because. Mindfulness. Fan 12345. Courage ladder. Intervention 2: Control group: Get routine care of the ward but  they do not receive advice.</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:
The effectiveness of focused solution brief counseling on anxiety and labor pain intensity in nulliparous women

When:
From september 1399

To whom:
All persons

Conditions:
Contact the researcher by email

Where to obtain:
Mohiti Mahdieh،mohitim1390@gmail.com، 00985142638001

How to obtain:
First an email will be sent then a phone call and ten days later the data will be emailed

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdieh Mohiti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.28, 25 Khayyam Alley ., Khayyam Ave. , Farhangian Town</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9318733333</zip>
        <telephone>+98 51 4261 0816</telephone>
        <email>mohitim1390@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdieh Mohiti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.28, 25 Khayyam Alley ., Khayyam Ave. , Farhangian Town</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9318733333</zip>
        <telephone>+98 51 4261 0816</telephone>
        <email>mohitim1390@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnancy age 37 to 41 weeks
Fetal health in the first trimester ultrasound examination
The pregnant mother has no special medical or midwifery problems
Wanted pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of psychotherapy or mental illness
addiction to cigarettes and drugs and alcohol
Have a history of recurrent miscarriage and infertility
Taking anti anxiety and anti depressant  drugs
The onset of labor pains</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Perform short-term focus counseling  before labor pains begin،single session counseling is a solution oriented approach for mothers who have not attended childbirth preparation classes during pregnancy and they have anxiety.For the mothers of the intervention group in addition to the routine care of the ward the researcher conducts one session Solution Focused Brief counseling for 45 to 60 minutes ،it is done individually. Solution Focused Brief counseling is a strengths based model. With different techniques and reminders of exceptions ،it helps pregnant mothers to recognize their abilities and overcome their anxiety during childbirth. Techniques used: Immediate relaxation or abdominal breathing. Riding on the wave of terror. Education Autogenic. Technique Just because. Mindfulness. Fan 12345. Courage ladder.</i_keyword>
      <i_keyword>Control group: Get routine care of the ward but  they do not receive advice</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety level in nulliparous womens. Timepoint: Anxiety assessment before intrevention begins and after consuling in dilatations 5 and 8 cm of  servics of servics. Method of measurement: Questionnaire Spielberger State-trait Anxiety Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Labor pain intensity. Timepoint: Before intervention and after intervention in dilatation 5,  8,10 cm cervics. Method of measurement: Visual Analogue Scale.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-15</approval_date>
        <contact_name>Ethics committee of Shahroud  University of Medical Sciences</contact_name>
        <contact_address>No. 28,Khayyam 25 Alley.,Khayyam Ave.,Farhangian Town Neyshabour Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
