<?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>IRCT20200728048234N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-07</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of Solution-Focused Brief Therapy on Psychological Well-being and Psychological distress of mothers with Prermature Neonates hospitalized in Neonatal Intensive Care Unit</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of Solution-Focused Brief Therapy (SFBT) on Psychological Well-being and Psychological distress of mothers with Prermature Neonates hospitalized in Neonatal Intensive Care Unit (NICU)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50181</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: How to randomize will be through random table. To use the random number table, each sample is given a code or machine number, the researcher randomly starts from a table point in a row or column, selecting the point by blindfolding and placing finger or pen tip on the table. Moves in the direction of a row or column.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Psychological well-being. Condition 2: Psychological distress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The method of this research is quasi-experimental and the research design is pre-test-post-test with a control group that will be performed on 60 mothers with infants admitted to the neonatal intensive care unit. For the mothers of the intervention group, after determining the score of psychological distress and psychological well-being using DASS and Ryff questionnaires, 4 sessions of  Solution-Focused Brief Therapy will be held for 90 minutes and 2 times a week.(Solution-Focused Brief  therapy is one of the effective and short-term counseling models that has a non-cognitive perspective on clients and helps clients find solutions to their current problems). Intervention 2: Control group: They don't receive any intervention.</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:
Data on the main outcomes of the research after the completion of research work can be published.

When:
Starting access to the data above is immediately after publishing the results.

To whom:
Researchers in academia and scientific institute are able to access research data.

Conditions:
In case of supplementary research, using data is permitted.

Where to obtain:
The applicant can contact the researcher to receive information via email.
nasim.shahrahmani@gmail.com  fatemehhassanshahi7374@gmail.com

How to obtain:
After submitting a written request from the applicant, the data will be provided to him/her as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Hassanshahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fourth unit, Second floor, Farhad building, Alley 25, Paeiz street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7177933354</zip>
        <telephone>+98 71 3743 5964</telephone>
        <email>fatemehhassanshahi7374@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Hassanshahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fourth unit, second floor,Farhad building,alley 25,Paeiz st</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7177933354</zip>
        <telephone>+98 71 3743 5964</telephone>
        <email>fatemehhassanshahi7374@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Premature birth (under 37 weeks)
Absence of obvious abnormalities or genetic disorders (gastrointestinal, cardiac, urinary, neurological abnormalities and trisomies 13,18,21)
No history of anxiety disorders and depression
Literate and fluent in Persian</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Attending another intervention or study while participating in this study
Lack of willingness and cooperation of mothers to complete the questionnaire and not attending training sessions
Occurrence of anxious events while studying
Maternal addiction
Transfer the baby to other medical centers
Infant death
Care by family members other than the mother</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The method of this research is quasi-experimental and the research design is pre-test-post-test with a control group that will be performed on 60 mothers with infants admitted to the neonatal intensive care unit. For the mothers of the intervention group, after determining the score of psychological distress and psychological well-being using DASS and Ryff questionnaires, 4 sessions of  Solution-Focused Brief Therapy will be held for 90 minutes and 2 times a week.(Solution-Focused Brief  therapy is one of the effective and short-term counseling models that has a non-cognitive perspective on clients and helps clients find solutions to their current problems).</i_keyword>
      <i_keyword>Control group: They don't receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological well-being score in the Ryff Scale. Timepoint: Before intervention and after the sessions are completed and one month after the intervention. Method of measurement: Ryff Psychological Well-Being Scale.</prim_outcome>
      <prim_outcome>Psychological distress score in the Depression, Anxiety and Stress Scale(21-DASS). Timepoint: Before intervention and after the sessions are completed and one month after the intervention. Method of measurement: The Depression, Anxiety and Stress Scale - 21 Itemes(21-DASS).</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-13</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical sciences</contact_name>
        <contact_address>Fourth unit, second floor, Farhad building, Alley 25, Paeiz street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
