<?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>IRCT2016021026499N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-11</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effects of a Voice Education Program on School Teachers' voice quality</public_title>
      <acronym>Voice handicap index</acronym>
      <scientific_title>The effects of a Voice Education Program on VHI Scores of Elementary School Teachers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>127</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21951</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Probable voice prblem.</hc_freetext>
      <i_freetext>Intervention 1: For teachers allocated to the training group, the training program lasted for 8 weeks. The entire 8-week program was obligatory, and teachers who did not follow the program were excluded from further analysis. For the first 4 weeks, the teachers participated in a voice education program. There was one session each week, with each session lasting for1 hour.&#13;
Participants learned about the mechanisms of voice production, how to protect their voice and larynx, how to identify and avoid vocal abusive behaviors, and how to substitute with non-abusive ones&#13;
Session 1:&#13;
Participants learned about concepts such as voice rest, keeping the vocal tract hydrated, and ways to reduce abusive voice use.&#13;
Session 2:&#13;
Participants learned the origins of voice abuse and how to modify their breathing pattern.&#13;
The instructors demonstrated the different breathing patterns, but there were no direct therapy sessions.&#13;
Session 3:&#13;
Teachers were introduced to the signs of laryngeal muscle tension and how to release it&#13;
by reduction and modification of abusive behaviors.&#13;
Session 4:&#13;
The instructors talked about the benefits of healthy nutrition and how to prevent reflux that help protecting larynx and voice.&#13;
Sessions 5-8:&#13;
There was no direct education for the next four weeks.&#13;
However the participants continued to discuss the barriers to adoption of the healthy behaviors, and how to overcome them.&#13;
Two instructors who were expert voice therapists and blind to the study hypothesis educated the teachers. They used pamphlets and PowerPoint presentations to support the teaching, with daily charts giving specific instructions for practice. Participants submitted their diaries to the instructor at the following session, in order that the instructors could record and follow up any items that the teachers failed to complete. The Instructors discussed any problems with performing the exercises. Intervention 2: Procedures–control group&#13;
At the end of the 8th week and after completion of the study, all educational materials including pamphlets and presentations were delivered to teachers in the control group. Therefore these teachers derived some benefit from taking part in the study. However, the control group did not participate in the instructor-led training program.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Faham</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation faculty, Abiverdi 1st</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 670 9404</telephone>
        <email>Mfaham@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Faham</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Faculty,Abiverdi 1</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 670 9404</telephone>
        <email>Maryam.faham@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Female teachers aged below 50 years; At least 5 years of teaching experience; Full-time employment, meaning teachers should be in the classroom at least 36 hours per week of 5 working days;&#13;
Exclusion Criteria:Any history of: voice therapy or professional singing instruction,  heart or pulmonary disease, head&amp; neck surgery or neurological disease, acute voice disorders due to structural complications in the larynx (e.g. nodule, polyp or vocal fold paralysis) in the past 2 years; smokers.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R 49.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dysphonia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For teachers allocated to the training group, the training program lasted for 8 weeks. The entire 8-week program was obligatory, and teachers who did not follow the program were excluded from further analysis. For the first 4 weeks, the teachers participated in a voice education program. There was one session each week, with each session lasting for1 hour.&#13;
Participants learned about the mechanisms of voice production, how to protect their voice and larynx, how to identify and avoid vocal abusive behaviors, and how to substitute with non-abusive ones&#13;
Session 1:&#13;
Participants learned about concepts such as voice rest, keeping the vocal tract hydrated, and ways to reduce abusive voice use.&#13;
Session 2:&#13;
Participants learned the origins of voice abuse and how to modify their breathing pattern.&#13;
The instructors demonstrated the different breathing patterns, but there were no direct therapy sessions.&#13;
Session 3:&#13;
Teachers were introduced to the signs of laryngeal muscle tension and how to release it&#13;
by reduction and modification of abusive behaviors.&#13;
Session 4:&#13;
The instructors talked about the benefits of healthy nutrition and how to prevent reflux that help protecting larynx and voice.&#13;
Sessions 5-8:&#13;
There was no direct education for the next four weeks.&#13;
However the participants continued to discuss the barriers to adoption of the healthy behaviors, and how to overcome them.&#13;
Two instructors who were expert voice therapists and blind to the study hypothesis educated the teachers. They used pamphlets and PowerPoint presentations to support the teaching, with daily charts giving specific instructions for practice. Participants submitted their diaries to the instructor at the following session, in order that the instructors could record and follow up any items that the teachers failed to complete. The Instructors discussed any problems with performing the exercises</i_keyword>
      <i_keyword>Procedures–control group&#13;
At the end of the 8th week and after completion of the study, all educational materials including pamphlets and presentations were delivered to teachers in the control group. Therefore these teachers derived some benefit from taking part in the study. However, the control group did not participate in the instructor-led training program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Voice quality. Timepoint: Before begininig the training period - At the end of the 8th weeks. Method of measurement: Voice handicap index.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-08-22</approval_date>
        <contact_name>Research Ethic Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>SUMS building, Zand Street Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
