<?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>IRCT20151025024686N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-04</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>glottal closure improvement in Muscle Tension dysphonia</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of voice therapy based on glottal closure improvement in singers with Muscle Tension dysphonia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43548</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization method with  two blocks will be used. Considering sample size of 20 subjects, 10 double blocks will be generated using www.sealedenvelope.com website. Concealing of randomization will be performed using secret codes in a pocket. Subject will receive a pocket when entering the study and based on the code in the pocket will be divided to certain group, Blinding description: Therapists and subjects will be blind to the grouping of subjects.  Pocket concealment was used to make participants and therapist blind to the grouping.

Judges will also be blind to the grouping of subjects and also will not be aware of the phases that the voice and video samples belong to (before or after treatment). For this purpose the assessment results including voice and the video samples of participants' performance played for judges without name, study phase and grouping.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Dysphonia. Condition 2: Voice disturbances.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group will receive laryngeal manual therapy performed by Mathieson LMT method.   Also exercises of "voice therapy based on glottal closure improvement" is provided to these participants.َ Assessment and treatment is continued for nine weeks and participants will have two 30-minutes sessions each week. Vocal assessments are performed before, after and two weeks after treatment ending.  Totally participants will have 3 assessment sessions and 10 treatment sessions. Intervention 2: Control group: This group will receive laryngeal manual therapy plus sham therapy for ten sessions. Laryngeal manual therapy is performed with Mathieson LMT method. In Sham therapy some information about larynx structure, voicing mechanism and laryngeal pathologies is provided. Assessment and treatment is continued for nine weeks and participants will have two 30-minutes sessions each week. Vocal assessments are performed before, after and two weeks after treatment ending.  Totally participants will have 3 assessment sessions and 10 treatment 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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nassim Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Science, School of Rehabilitation, Nezam Street, Shahid Shah Nazari Street, Madar Square, Mirdamad Blv.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>nassim.slp@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Farhad Torabinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Science, School of Rehabilitation, Nezam Street, Shahid Shah Nazari Street, Madar Square, Mirdamad Blv, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>rehab@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>at least 4 years of professional singing experience
history of voice disorder during last month
diagnosed with primary muscle tension dysphonia (MTD)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>history of allergy, laryngeal blunt trauma, head injury and phonosurgery
hearing impairment
being smoker</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R49.0</hc_code>
      <hc_code>R49.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dysphonia</hc_keyword>
      <hc_keyword>Other and unspecified voice disturbances</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This group will receive laryngeal manual therapy performed by Mathieson LMT method.   Also exercises of "voice therapy based on glottal closure improvement" is provided to these participants.َ Assessment and treatment is continued for nine weeks and participants will have two 30-minutes sessions each week. Vocal assessments are performed before, after and two weeks after treatment ending.  Totally participants will have 3 assessment sessions and 10 treatment sessions.</i_keyword>
      <i_keyword>Control group: This group will receive laryngeal manual therapy plus sham therapy for ten sessions. Laryngeal manual therapy is performed with Mathieson LMT method. In Sham therapy some information about larynx structure, voicing mechanism and laryngeal pathologies is provided. Assessment and treatment is continued for nine weeks and participants will have two 30-minutes sessions each week. Vocal assessments are performed before, after and two weeks after treatment ending.  Totally participants will have 3 assessment sessions and 10 treatment sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Acoustic measures. Timepoint: Before intervention, after intervention, two weeks after intervention. Method of measurement: Acoustic analysis using Praat software.</prim_outcome>
      <prim_outcome>Vocal fold closed quotient. Timepoint: Before intervention, after intervention, two weeks after intervention. Method of measurement: Electroglottography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Voice Quality. Timepoint: Before intervention, after intervention, two weeks after intervention. Method of measurement: Auditory-Perceptual Rating Instrument for the Operatic Singing Voice( EAI scale).</sec_outcome>
      <sec_outcome>Singing voice handicap. Timepoint: Before intervention, after intervention, two weeks after intervention. Method of measurement: Persian version of Singing voice handicap index.</sec_outcome>
      <sec_outcome>Stroboscopic observational indices. Timepoint: Before intervention, after intervention, two weeks after intervention. Method of measurement: Voice-Vibratory Assessment With Laryngeal Imaging (VALI) Form.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-04</approval_date>
        <contact_name>Ethnic committee of Iran University of medical science</contact_name>
        <contact_address>Iran University of Medical Science,Hemmat highway, Tehran, Iran. تهران Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
