<?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>IRCT20250222064815N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-06</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of psycho education on mothers' self-efficacy and anxiety before their children's surgery</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of psychological education on mothers' self-efficacy and their anxiety before their children's surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82041</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this randomized controlled trial, we assign 62 participants to intervention or control groups using computerized randomization. Eligible mothers of children referred to Imam Ali (AS) Hospital’s pediatric surgery clinic are enrolled after meeting inclusion criteria. Allocation is based on the order of enrollment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety and self-efficacy of mothers before their children's surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group:Three preoperative psychological education sessions for mothers:Session 1:Surgical education (admission process, procedure duration, recovery, hospitalization) Anxiety analysis using DTR technique Cognitive restructuring (information provision, probability evaluation, problem-solving) Session 2 :Surgery education review (if needed)Cognitive restructuring using de-catastrophizing Stress management:Progressive muscle relaxation training (with audio guide)Coping strategies for stressful situations. Session 3: Guided imagery for post-operative concerns Child care techniques:Distraction methods Pleasant stimulus provision. Intervention 2: The control group will participate in a single preoperative education session providing comprehensive information about the surgical process, including hospitalization procedures, expected duration of surgery and recovery, postoperative care requirements, and necessary hospitalization items. The session also includes a therapist-facilitated discussion where mothers can share concerns and questions about their child's surgery. This discussion is guided by the therapist but does not include any specialized psychological education or intervention, while providing a platform for participants to exchange experiences.</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 No more information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Zargar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib Street, Isfahan University of Medical Sciences and Health Services, Faculty of Medicine</address>
        <city>اصفهان</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 8101</telephone>
        <email>fatemehzargar@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Zargar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib Street, Isfahan University of Medical Sciences and Health Services, Faculty of Medicine</address>
        <city>اصفهان</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 8101</telephone>
        <email>fatemehzargar@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers of children under 7 years of age on the verge of pediatric urological surgery
Absence of comorbid psychiatric disorders in children
Absence of major psychiatric disorders such as mood and psychotic disorders in mothers
Mothers with a Spielberger State Anxiety Scale score above 43
First-time surgery in children
Mothers having the ability to read and write
Willingness to participate in the research and signing the consent form</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mothers of children undergoing emergency or non-urologic surgeries
Diagnosis of any psychiatric disorder in either mother or child
Maternal Spielberger State Anxiety score &lt;43
Children with previous surgical experience
Illiterate mothers or those unable to complete questionnaires
Refusal to participate or incomplete baseline data</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group:Three preoperative psychological education sessions for mothers:Session 1:Surgical education (admission process, procedure duration, recovery, hospitalization) Anxiety analysis using DTR technique Cognitive restructuring (information provision, probability evaluation, problem-solving) Session 2 :Surgery education review (if needed)Cognitive restructuring using de-catastrophizing Stress management:Progressive muscle relaxation training (with audio guide)Coping strategies for stressful situations. Session 3: Guided imagery for post-operative concerns Child care techniques:Distraction methods Pleasant stimulus provision.</i_keyword>
      <i_keyword>The control group will participate in a single preoperative education session providing comprehensive information about the surgical process, including hospitalization procedures, expected duration of surgery and recovery, postoperative care requirements, and necessary hospitalization items. The session also includes a therapist-facilitated discussion where mothers can share concerns and questions about their child's surgery. This discussion is guided by the therapist but does not include any specialized psychological education or intervention, while providing a platform for participants to exchange experiences.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score on the Spielberger Anxiety Inventory. Timepoint: Before the start of psychoeducation sessions and after the sessions are completed until before surgery. Method of measurement: Spielberger State-Trait Anxiety Inventory.</prim_outcome>
      <prim_outcome>Dumka Parenting Self-Efficacy Scale Score. Timepoint: Before the start of psychoeducation sessions and after the sessions are completed until before surgery. Method of measurement: Domka Parenting Self-Efficacy Scale.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-14</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>No. 33, Zanbaq 20, Zanbaq Blvd., Azimieh, Karaj Town Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
