<?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>IRCT20210511051260N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-12</date_registration>
      <primary_sponsor>Research Vice Chancellor of Mashhad University of Medical Science</primary_sponsor>
      <public_title>Determining the effect of nursing counseling on maternal anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Nursing Consultation based on Peplau’s theory on Perceived Stress and Anxiety of Patient's mothers with Gastrointestinal atresia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58283</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: In order to assign samples to each of the intervention and control groups, the randomization method with blocks will be used, so that first the size of 4 blocks will be considered. According to the sample size (60 people), 15 blocks will be selected based on a table of random numbers and individuals will be assigned to groups based on their position in the blocks, Blinding description: To reduce the bias or bias related to the intervention and evaluate the consequences, the method of blind or covering a blind single blind is followed, with this method, the outcome can be measured objectively.
In this method, the trial is planned in such a way that the participant does not know which of the two control or test groups he belongs to.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gastrointestinal atresia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, Peplae's therapeutic communication theory is performed individually in 4 stages: introduction, identification, exploitation and dissolution, and re-testing is performed after the sessions. Introduction: Introducing the researcher to the child care client with gastrointestinal atresia - Gaining the client's trust - Explaining the present research - Clarifying the client's expectations from the treatment team (nurse, doctor and members of the treatment team) Patient - Defining the problem and deciding on the type of services required - A brief and understandable explanation to the client about the treatment and care that will be provided by the treatment team for the sick child - Determining the help needed by the client with a sick child from the treatment team : Choosing the right professional help - Encouraging the client to express feelings and ambiguities - Asking and answering the client's questions - Talking about the client's fears and stresses and anxiety - Talking about the client's issues and problems in relation to the sick child - Creating a sense of belonging And the ability to deal with the problem in the client. Exploitation stage: Using professional assistance to the client based on the patient's child's problems-Expressing the benefits of services used based on needs-Creating a sense of the client's important role as an integral part of the child care environment Patient-Leading the client to gain independence in caring Sick child-care planning based on each patient's problems-two to three sessions before reaching the closing stage Reminding the client to the sick child-problem solving and closing stage: termination of professional relationships-examining the positive and negative aspects of the program from the client's point of view-evaluation Results or not? - If not, why? - Investigate the reasons for the failure of the program and what should be done to achieve success - Provide pamphlets - CDs - Booklets required to inform the client to continue caring for the sick child In-house meetings are done individually and all face-to-face and oral consultations are done with educational aids such as pamphlets, booklets and educational CDs. The entire course lasts 8 months. Intervention 2: Control group: They did not receive any training program and in only two sessions, at the beginning and end of the study, they were given the Demographic Information Questionnaire and the Disease Profile Questionnaire, the Cohen Perceived Stress Questionnaire (PSS-14) and the Spielberger Anxiety Inventory (STAI).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Reza Behnam Vashani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taghiabad Street,PhD Cross,School of Nursing and Midwifery.Mashhad University of Medical Sciences</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9567163940</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>BEHNAMHR@MUMS.AC.IR</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Reza Behnam Vashani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taghiabad Street,PhD Cross,school of Nursing and Midwifery.Mashhad University of Medical Science</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9567163940</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>behnamhr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers whose children have gastrointestinal atresia with a doctor's approval
Willingness to participate in research
Having informed consent of a healthy mother (has no known psychiatric disorder and is not being treated { has no mood disorders and anxiety and is not being treated in this regard})
The patient is the new admission of the ward and her first surgery in this field.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Existence of major stressful events in life (death of first-degree relatives, financial bankruptcy, accident, severe family dispute with spouse) during the last 6 months
Diagnosis of a known psychiatric disorder in the mother (having a mood and anxiety disorder and being treated)
Severe medical disorder known in previous child</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q41.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Congenital absence, atresia and stenosis of other specified parts of small intestine</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, Peplae's therapeutic communication theory is performed individually in 4 stages: introduction, identification, exploitation and dissolution, and re-testing is performed after the sessions. Introduction: Introducing the researcher to the child care client with gastrointestinal atresia - Gaining the client's trust - Explaining the present research - Clarifying the client's expectations from the treatment team (nurse, doctor and members of the treatment team) Patient - Defining the problem and deciding on the type of services required - A brief and understandable explanation to the client about the treatment and care that will be provided by the treatment team for the sick child - Determining the help needed by the client with a sick child from the treatment team : Choosing the right professional help - Encouraging the client to express feelings and ambiguities - Asking and answering the client's questions - Talking about the client's fears and stresses and anxiety - Talking about the client's issues and problems in relation to the sick child - Creating a sense of belonging And the ability to deal with the problem in the client. Exploitation stage: Using professional assistance to the client based on the patient's child's problems-Expressing the benefits of services used based on needs-Creating a sense of the client's important role as an integral part of the child care environment Patient-Leading the client to gain independence in caring Sick child-care planning based on each patient's problems-two to three sessions before reaching the closing stage Reminding the client to the sick child-problem solving and closing stage: termination of professional relationships-examining the positive and negative aspects of the program from the client's point of view-evaluation Results or not? - If not, why? - Investigate the reasons for the failure of the program and what should be done to achieve success - Provide pamphlets - CDs - Booklets required to inform the client to continue caring for the sick child In-house meetings are done individually and all face-to-face and oral consultations are done with educational aids such as pamphlets, booklets and educational CDs. The entire course lasts 8 months.</i_keyword>
      <i_keyword>Control group: They did not receive any training program and in only two sessions, at the beginning and end of the study, they were given the Demographic Information Questionnaire and the Disease Profile Questionnaire, the Cohen Perceived Stress Questionnaire (PSS-14) and the Spielberger Anxiety Inventory (STAI)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived stress score. Timepoint: Perceived stress score with the help of a questionnaire in two stages before the intervention (beginning of the study) and after the intervention (end of the study). Method of measurement: Cohen Perceived Stress Questionnaire (PSS-14).</prim_outcome>
      <prim_outcome>Anxiety score. Timepoint: Anxiety scores with the help of Anxiety Questionnaire in two stages before the intervention (beginning of the study) and after the intervention (end of the study). Method of measurement: Spielberger Anxiety Inventory (STAI).</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>Research Vice Chancellor of Mashhad University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-06</approval_date>
        <contact_name>Ethics Committee of the School of Nursing and Midwifery Mashhad University of Medical Sciences</contact_name>
        <contact_address>Taghiabad Street,PhD Cross,School of Nursing and Midwifery.Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
