<?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>IRCT20230827059274N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-05</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The  efficacy of theory of mind practices on perception of mental verbs</public_title>
      <acronym></acronym>
      <scientific_title>The investigation of efficacy of theory of mind practices on perception of mental verbs in Farsi-speaking children aged 5-7 -year- old with hearing aid and cochlear implant</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72289</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, based on the inclusion and inclusion criteria, the names of eligible children are extracted and their names are placed in a simple random manner and individually in sealed envelopes in each of the intervention and control groups, Blinding description: The evaluators who rate, code and analyze the results will be unaware of the demographic information of the children, the time period of the evaluations and the grouping of the children. Therefore, the present randomized clinical trial is a blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hearing loss.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Children with hearing impairment who use hearing aids and cochlear implant (2 intervention groups) will be evaluated by mental verb perception test and theory of mind test. Then, the theory of mind intervention will be implemented for 16 sessions of thirty minutes in 8 weeks. One month after the end of the intervention period, evaluations will be done again and the amount of changes will be recorded. Intervention 2: Control group: Children with hearing impairment who use hearing aids and cochlear implant (2 intervention groups) will be evaluated by mental verb perception and theory of mind test. Then, for 16 sessions of thirty minutes in 8 weeks, common speech therapy will be performed. One month after the end of the intervention period, evaluations will be done again and the amount of changes will be recorded.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The information remains confidential with the researcher</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Hassanati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Social Welfare and Rehabilitation, Kudakyar Alley, Daneshju Blvd., Evin, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 7173 2847</telephone>
        <email>fatemeh_hasanati@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ّFatemh hassanati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Social Welfare and Rehabilitation Sciences, Kodakyar Ave., daneshjo Blvd.,Evin, Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 7173 2847</telephone>
        <email>fatemeh_hasanati@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>IQ in the normal range
congenital hearing loss before the language learning period of sensorineural type
Unilateral cochlear implantation before 5 years of age
At least one year has passed since receiving the prosthesis
Passing speech therapy programs in the past year
Predominance of Farsi language in the speech of the child and her family(feminine)
Ability to speak simple sentences
Age range between 5 and 7 years
Natural cognitive skills based on children's history and medical records and the Wechsler intelligence test, which is administered by a psychologist
Absence of sensory problems such as blindness diagnosed by a specialist doctor based on the history and medical records of children
Absence of neurological problems such as movement disorders and paralysis in the limbs and face, epilepsy and convulsions diagnosed by a specialist doctor based on the history and medical file of children
Absence of psychological and emotional problems such as mental retardation, hyperactivity, autism, and medical syndromes
No receiving interventions in the field of theory of mind or understanding mental actions</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>7 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Discontinuing  the research process on behalf of the child or the child's parents
Prosthesis or hearing aid failure or the need for major repairs that lead to the child being deprived of the prosthesis for several weeks
The occurrence of diseases that lead to the process of research interventions being interrupted for several weeks (simple colds are excluded from this rule)
History of receiving theory of mind exercises
Using hearing aids and cochlear implants at the same time</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H91.90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified hearing loss, unspecified ear</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Children with hearing impairment who use hearing aids and cochlear implant (2 intervention groups) will be evaluated by mental verb perception test and theory of mind test. Then, the theory of mind intervention will be implemented for 16 sessions of thirty minutes in 8 weeks. One month after the end of the intervention period, evaluations will be done again and the amount of changes will be recorded.</i_keyword>
      <i_keyword>Control group: Children with hearing impairment who use hearing aids and cochlear implant (2 intervention groups) will be evaluated by mental verb perception and theory of mind test. Then, for 16 sessions of thirty minutes in 8 weeks, common speech therapy will be performed. One month after the end of the intervention period, evaluations will be done again and the amount of changes will be recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improvement in perception of mental verbs with changing in perception of mental verb test. Timepoint: 8 weeks. Method of measurement: Perception of mental verbs  test.</prim_outcome>
      <prim_outcome>Improvement in theory of mind. Timepoint: 8 weeks. Method of measurement: Perception of theory of mind test.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-22</approval_date>
        <contact_name>Ethics committee of university of social welfare and rehabilitation sciences</contact_name>
        <contact_address>University of Social Welfare and Rehabilitation Sciences, Kodakyar Ave., Daneshjo Blvd.,Evin, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
