<?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>IRCT20230306057636N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-14</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of face-to-face voice therapy and Telepractice in patients with Muscle Tension Dysphonia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of face-to-face voice therapy and Telepractice in patients with Muscle Tension Dysphonia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69141</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is done in the form of a lottery, so that the name of each participant is written on the same size and similar papers. The names are placed in a container. After that, the names are placed in two groups in order of coming out. One person enters the intervention group and one person enters the control group (individuals receive remote treatment and couples receive face-to-face treatment) respectively. Randomization is done by a person who is not involved in the research process, Blinding description: After providing the treatments, a speech therapist (separate from the therapist who provided the treatment) will evaluate the results without knowing the grouping of the clients.
The researcher examines and reports the results without knowing whether each data group is related to the control group or the intervention.
The data analyzer analyzes the Spss file and does not meet the participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Muscle Tension Dysphonia(MTD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 23 clients with muscle tension  dysphonia, whose disorder was confirmed by an otolaryngologist and stroboscopic evaluations by a speech therapist, six voice facilitating techniques including exaggerated chewing, breathing exercises, sighing and yawning, open mouth, glottal fry and confidential speech in 18 half-hour sessions online and on the platform of ZOOM software. Intervention 2: Control group: 23 clients with muscle tension  dysphonia, whose disorder was confirmed by an otolaryngologist and stroboscopic evaluations by a speech therapist, six voice facilitating techniques including exaggerated chewing, breathing exercises, sighing and yawning, open mouth, glottal fry and confidential speech in 18 half-hour face-to-face sessions.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Sharifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>corner of Wahabi, 8th St. West - Kianpars</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6155845489</zip>
        <telephone>+98 917 149 5644</telephone>
        <email>z.sharifi21377@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negin Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koi Ostadan - Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9111111119</zip>
        <telephone>+98 916 506 0146</telephone>
        <email>neginmoradist@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to read and write
Monolingual and Farsi-speaking patients
Clients with dysphonia caused by muscle tension who have been diagnosed by an otolaryngologist and evaluated using video stroboscopy by a professional speech therapist with more than 15 years of experience.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>record of receiving sound therapy services
suffering from colds and allergic and respiratory diseases for the past two months (question from the patient)
taking drugs affecting the voice
having auditory system disease
having thyroid disease and hormonal problems
performing any surgery that leads to hoarseness or bad effects on the voice and these effects continue</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R49.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other voice and resonance disorders</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: 23 clients with muscle tension  dysphonia, whose disorder was confirmed by an otolaryngologist and stroboscopic evaluations by a speech therapist, six voice facilitating techniques including exaggerated chewing, breathing exercises, sighing and yawning, open mouth, glottal fry and confidential speech in 18 half-hour sessions online and on the platform of ZOOM software.</i_keyword>
      <i_keyword>Control group: 23 clients with muscle tension  dysphonia, whose disorder was confirmed by an otolaryngologist and stroboscopic evaluations by a speech therapist, six voice facilitating techniques including exaggerated chewing, breathing exercises, sighing and yawning, open mouth, glottal fry and confidential speech in 18 half-hour face-to-face sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The total score of the Dysphonia Severity Index (DSI). Timepoint: Measuring the total score of dysphonia severity index before treatment and one month later. Method of measurement: Dysphonia Severity Index.</prim_outcome>
      <prim_outcome>The total score of the Voice Handicap Index(VHI). Timepoint: Measuring the total score of Voice Handicap index before treatment and one month later. Method of measurement: Voice handicap index questionnaire.</prim_outcome>
      <prim_outcome>The total score of the Vocal Tract Discomfort index(VTD). Timepoint: Measuring the total score of Vocal Tract Discomfort index before treatment and one month later. Method of measurement: Vocal Tract Discomfort index questionnaire.</prim_outcome>
      <prim_outcome>Vocal Fatigue Index (VFI) first part. Timepoint: Measuring the total score of Vocal Tract Discomfort index before treatment and one month later. Method of measurement: Vocal fatigue index questionnaire.</prim_outcome>
      <prim_outcome>Vocal Fatigue Index (VFI) second part. Timepoint: Measuring the total score of Vocal Tract Discomfort index before treatment and one month later. Method of measurement: Vocal fatigue index questionnaire.</prim_outcome>
      <prim_outcome>Vocal Fatigue Index (VFI) third part. Timepoint: Measuring the total score of Vocal Tract Discomfort index before treatment and one month later. Method of measurement: Vocal fatigue index questionnaire.</prim_outcome>
      <prim_outcome>Auditory-perceptual assessment (GRBAS). Timepoint: Measuring the total score of Vocal Tract Discomfort index before treatment and one month later. Method of measurement: GRBAS index, which examines 5 characteristics of the overall severity of the disorder, voice harshness, breathlessness, voice asthenia, and struggle.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-04</approval_date>
        <contact_name>Ethics committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Ahvaz - Boulevard of Medical Sciences - Jundishapur Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
