<?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>IRCT20170922036319N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-04</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of voice therapy in improving voice quality in teachers</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study on the efficacy of symptomatic relaxation techniques, laryngeal manual therapy and combined method in voice therapy in teachers with muscle tension dysphonia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27187</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Muscle tension dysphonia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: symptomatic voice therapy :One of the direct approaches is symptomatic voice therapy which proposed by Boone (1971) is based on the principles of behavior therapy. This approach uses a variety of voice facilitating techniques through direct modification respiratory and phonatory systems lead to improvement in symptoms of voice production on correction of voice production symptoms and manipulates voice characteristic. The treatment techniques were presented for 10 individual sessions twice a week and each session lasted approximately 45 min. Intervention 2: Intervention group: manual therapy: Physiologic voice therapy approach is another direct philosophy which recently has been considered in voice therapy of MTD aimed to directly alter or modify the physiology of the vocal mechanism. It seems laryngeal muscle tension imbalance is one possible physiologic cause of voice disturbances so laryngeal manual therapy can be noticed as a useful primary intervention in dysphonia, particularly MTD. In functional voice disorders muscle imbalance pressure, abnormal coordination patterns of muscles and intrinsic and extrinsic laryngeal muscles tension may change the cartilaginous structures and position of the larynx. Circumlaryngeal manual therapy proposed by Aronson is the first laryngeal manual therapy technique which has been gained more attention.The treatment techniques were presented for 10 individual sessions twice a week and each session lasted approximately 45 min. Intervention 3: Intervention group: combined method: Combined approaches combine one or more therapies to treat patients with voice impairment. The treatment techniques were presented for 10 individual sessions twice a week and each session lasted approximately 45 min.</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>Samira Aghadoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Speech therapy department, Tehran University of Medical Sciences Rehabilitation Faculty, Pich Shemiran, Enghelab St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1482546</zip>
        <telephone>+98 21 4489 3073</telephone>
        <email>khoddami@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samira Aghadoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Speech therapy department, Tehran University of Medical Sciences Rehabilitation Faculty, Pich Shemiran, Enghelab St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>64+654</zip>
        <telephone>+98 21 4489 3073</telephone>
        <email>khoddami@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Teachers included who aged 25 to 50 years old
No history of allergy, hearing loss, endocrine diseases, neurologic disorders, addiction, and voice therapy. 
They should have no catching colds and upper respiratory tract infection 1 month before initiation and duration the study.
No use of cigarettes, drugs and alcoholic beverages
Having voice complaint that lasted more than 3 months
Not participated in other voice therapy program
Not having a history or presence of various diseases associated with the digestive system, with the exception of gastroesophageal reflux due to its relatively high prevalence
Receive MTD diagnosis by ENT physician and speech and language pathology
They should not place in a menopause or menstrual period at the time of study.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>They excluded when they were not able to continue treatment protocols and lose any of above inclusion criteria.</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: symptomatic voice therapy :One of the direct approaches is symptomatic voice therapy which proposed by Boone (1971) is based on the principles of behavior therapy. This approach uses a variety of voice facilitating techniques through direct modification respiratory and phonatory systems lead to improvement in symptoms of voice production on correction of voice production symptoms and manipulates voice characteristic. The treatment techniques were presented for 10 individual sessions twice a week and each session lasted approximately 45 min</i_keyword>
      <i_keyword>Intervention group: manual therapy: Physiologic voice therapy approach is another direct philosophy which recently has been considered in voice therapy of MTD aimed to directly alter or modify the physiology of the vocal mechanism. It seems laryngeal muscle tension imbalance is one possible physiologic cause of voice disturbances so laryngeal manual therapy can be noticed as a useful primary intervention in dysphonia, particularly MTD. In functional voice disorders muscle imbalance pressure, abnormal coordination patterns of muscles and intrinsic and extrinsic laryngeal muscles tension may change the cartilaginous structures and position of the larynx. Circumlaryngeal manual therapy proposed by Aronson is the first laryngeal manual therapy technique which has been gained more attention.The treatment techniques were presented for 10 individual sessions twice a week and each session lasted approximately 45 min.</i_keyword>
      <i_keyword>Intervention group: combined method: Combined approaches combine one or more therapies to treat patients with voice impairment. The treatment techniques were presented for 10 individual sessions twice a week and each session lasted approximately 45 min</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dysphonia severity index. Timepoint: Before, during and after treatment. Method of measurement: Acoustic analysis and formula calculation.</prim_outcome>
      <prim_outcome>Grade of dysphonia. Timepoint: Before, during and after treatment. Method of measurement: Auditory perceptual judgments.</prim_outcome>
      <prim_outcome>Voice handicap index. Timepoint: Before, during and after treatment. Method of measurement: Self-assessment questionnaire.</prim_outcome>
      <prim_outcome>Repetition of vocal tract discomfort. Timepoint: Before and after treatment. Method of measurement: Self-assessment questionnaire.</prim_outcome>
      <prim_outcome>Severity of vocal tract discomfort. Timepoint: Before and after treatment. Method of measurement: Self-assessment questionnaire.</prim_outcome>
      <prim_outcome>Stroboscopic characteristic. Timepoint: Pre and post treatment. Method of measurement: Observation and perceptual judgment.</prim_outcome>
      <prim_outcome>Pattern of muscle tension. Timepoint: Pre and post treatment. Method of measurement: Observation and perceptual judgment.</prim_outcome>
      <prim_outcome>Muscle tension of larynx. Timepoint: Before, during and after treatment. Method of measurement: Palpation.</prim_outcome>
      <prim_outcome>Length of larynx. Timepoint: Before, during and after treatment. Method of measurement: Palpatory.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-31</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Rehabilitation school, Darvazeh Shemiran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
