<?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>IRCT20230913059426N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-02</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Offline tele voice therapy exercises in singers with muscle tension dysphonia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison "vocal function exercises" and "Flow-resistant tube" using offline tele voice therapy in singers with muscle tension dysphonia: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>63</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72756</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: ---, Randomization description: To randomly divide the participants into three groups including control group, flow-resistant tube (FRT), and vocal function exercises (VFE), the method of simple randomization using a table of random numbers is used. Because the list of all patients is not known before initiation of the study and the confounding variable for classification is not introduced, available sampling is the appropriate method. So, with the entry of each patient based on the randomization list specified in advance, each participant is assigned randomly to one of the control, FRT, and VFE groups. Therefore, the unit for randomization is individual, Blinding description: The present study is a double-blind clinical trial study. First, the purpose of the study is explained to the participants. They are informed that in this study, we will have three groups including the control group (no treatment), the FRT group and the VFE group, who will receive the treatment remotely and offline. Both FRT and VFE groups receive voice therapy methods, the effectiveness of which has already been confirmed by various studies for patients with voice disorders, including singers, in face-to-face treatments. Participants are unaware of which of the three groups they belong to. That is, the time of pre-treatment and post-treatment evaluations is set so that the study participants do not meet each other and are unaware of the treatment they are receiving. Participants will be randomly assigned to one of three study groups; Treatments are provided individually. Treatment is provided by a member of the research team. Evaluations before and after treatment are done by another evaluator. Therefore, both the therapist is unaware of the outcome evaluation results and the evaluator is unaware of the random allocation of participants and the content of the treatment. Other members of the research team are also unaware of the results of the outcome assessment and how the participants were allocated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Muscle tension dysphonia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Vocal Function Exercises (VFE). The hierarchy of these exercises includes four steps as follows: 1) Phonating the /i/ sound in the musical note F3 for men and F4 for women (the selected note in this step can go up or down by two notes at most). Objective: To produce an "e" sound equal to the longest Articulation of "s" that each participant can produce. Your position should be in the front focus. All exercises should be done as softly as possible but not breathy; 2) Glide the word /knoll/ from the lowest note to the highest note. The goal is not to have voice breaks. Glide requires the use of all laryngeal muscles. The patient's lips are rounded and a supportive vibration should be felt in the lips. 3) Glide the word /knoll/ from the highest note to the lowest note. The goal is to produce without voice breaks. This exercise is done with a half yawn. The throat is open and the focus is on the perceptible vibration of the lips. 4) Phonating the five musical notes C-D-E-F-G (third and forth octave) as much as possible in the word /ol/ (selected notes can go up or down by two notes). The goal is the same as step one. Production is done with an open throat and vibrating lips. Participants receive their treatment plan, which is a four-week program, offline. Detailed information about VFE exercises in the form of a PDF file, educational videos related to the exercises suitable for Persian speakers, and a file related to common questions and answers prepared in advance by researchers under the supervision of experts, are presented to the participants via social network. will be. On the first day of the treatment period, all this information and videos related to the treatment are provided to the participants. After receiving information about the exercises and watching the initial videos, the participants will perform the exercises related to their treatment plan according to the provided program. Daily exercises for the VFE group will consist of two eight-minute meals (morning and evening).​. Intervention 2: Intervention group: SOVT using Flow Resistant Tube(FRT) exercises. FRT exercises involve voice production through a plastic straw 14.1 cm long and 0.4 in diameter. Participants are asked to use the straw in such a way that airflow is exchanged only through the straw (not through the nose or around the straw). Also, the abdominal-chest (non-clavicular) breathing pattern should be used and the upper body position should be relaxed. Exercises should be done with full voice; However, due to creating a semi-occluded vocal tract, the perception of loudness has been reduced. The hierarchy of FRT exercises in the second group includes four stages as follows: 1) Glide of the /o/ sound from the lowest note to the highest note and from the highest note to the lowest note. This exercise should be repeated ten times. 2) Say a word starting with /o/ five to seven times. Repeat this exercise ten times. This exercise should be done by changing the pitch and loudness of the voice and by increasing the breathing support (in contrast to the vocal folds adduction). 3) A word starting with /o/ should be sung through a tube with a melody but without producing the word. Practice ten short songs of one verse or long songs equivalent to it. 4) Read from the text through a straw but without producing words. Read approximately five paragraphs of medium length (approximately five to ten sentences) for each exercise. Each of the FRT exercises is done in one minute. Participants receive their treatment plan, which is a four-week program, offline. Detailed information about FRT exercises in the form of a PDF file, educational videos related to the exercises suitable for Persian speakers and a file related to common questions and answers prepared in advance by researchers and under the supervision of experts, are presented to the participants via social network. On the first day of the treatment period, all this information and videos related to the treatment are provided to the participants. After receiving information about the exercises and watching the initial videos, the participants will perform the exercises related to their treatment plan according to the provided program. Daily exercises for the FRT group will include 4 meals of 4-minute (twice in the morning and twice in the afternoon). Intervention 3: Control group: No treatment. The control group will not receive any treatment program during the study period.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Wholes are divisible after identifying unidentifiable individuals.

When:
Access to the data starts six months after the paper printing of the study results in the form of an article.

To whom:
Data access is possible for researchers working in scientific and academic institutions.

Conditions:
In order to access the data, the request should be sent to the editor of the journal in which the article was published. The data can only be used for studies similar to the present study to perform statistical analyzes by the relevant researcher or researchers.

Where to obtain:
If the results of the study will be published in the form of an article, the applicants must send their request to access the data to the editor of the journal. If the journal allows the publication of the data, the authors of the article can submit their request to the following address.
Department of Speech Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Enghelab Avenue, Pitch-e-shemiran, Tehran 11489, Iran.

How to obtain:
1- Sending an email to the editor of the magazine.
2- Send email to khoddami@tums.ac.ir

Comments:
---</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Seyyedeh Maryam Khoddami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation, corner of Safi Alishah St., Pich Shamiran St., Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65111-11489</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>khoddami@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyedeh Maryam Khoddami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation, corner of Safi Alishah St., Pich Shamiran St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65111-11489</zip>
        <telephone>+98 21 7753 3939</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>Have at least one year of singing experience;
Be in the age range of 18 to 60 years;
Based on the results of voice self-assessment, voice history taking, larynx observation, and perceptual voice evaluation, receive a primary muscle tension dysphonia (MTD) diagnosis;
Do not have vocal fold pathologies (benign or malignant);
Do not have a history of voice therapy;
Do not have an addiction to smoking or alcohol.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have a history of diagnosis of neurological disorders as well as cancer, radiotherapy or  of head and neck;
Have an upper respiratory tract infection at the time of the evaluation and three weeks before the evaluation.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R49.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dysphonia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Vocal Function Exercises (VFE). The hierarchy of these exercises includes four steps as follows: 1) Phonating the /i/ sound in the musical note F3 for men and F4 for women (the selected note in this step can go up or down by two notes at most). Objective: To produce an "e" sound equal to the longest Articulation of "s" that each participant can produce. Your position should be in the front focus. All exercises should be done as softly as possible but not breathy; 2) Glide the word /knoll/ from the lowest note to the highest note. The goal is not to have voice breaks. Glide requires the use of all laryngeal muscles. The patient's lips are rounded and a supportive vibration should be felt in the lips. 3) Glide the word /knoll/ from the highest note to the lowest note. The goal is to produce without voice breaks. This exercise is done with a half yawn. The throat is open and the focus is on the perceptible vibration of the lips. 4) Phonating the five musical notes C-D-E-F-G (third and forth octave) as much as possible in the word /ol/ (selected notes can go up or down by two notes). The goal is the same as step one. Production is done with an open throat and vibrating lips. Participants receive their treatment plan, which is a four-week program, offline. Detailed information about VFE exercises in the form of a PDF file, educational videos related to the exercises suitable for Persian speakers, and a file related to common questions and answers prepared in advance by researchers under the supervision of experts, are presented to the participants via social network. will be. On the first day of the treatment period, all this information and videos related to the treatment are provided to the participants. After receiving information about the exercises and watching the initial videos, the participants will perform the exercises related to their treatment plan according to the provided program. Daily exercises for the VFE group will consist of two eight-minute meals (morning and evening).​</i_keyword>
      <i_keyword>Intervention group: SOVT using Flow Resistant Tube(FRT) exercises. FRT exercises involve voice production through a plastic straw 14.1 cm long and 0.4 in diameter. Participants are asked to use the straw in such a way that airflow is exchanged only through the straw (not through the nose or around the straw). Also, the abdominal-chest (non-clavicular) breathing pattern should be used and the upper body position should be relaxed. Exercises should be done with full voice; However, due to creating a semi-occluded vocal tract, the perception of loudness has been reduced. The hierarchy of FRT exercises in the second group includes four stages as follows: 1) Glide of the /o/ sound from the lowest note to the highest note and from the highest note to the lowest note. This exercise should be repeated ten times. 2) Say a word starting with /o/ five to seven times. Repeat this exercise ten times. This exercise should be done by changing the pitch and loudness of the voice and by increasing the breathing support (in contrast to the vocal folds adduction). 3) A word starting with /o/ should be sung through a tube with a melody but without producing the word. Practice ten short songs of one verse or long songs equivalent to it. 4) Read from the text through a straw but without producing words. Read approximately five paragraphs of medium length (approximately five to ten sentences) for each exercise. Each of the FRT exercises is done in one minute. Participants receive their treatment plan, which is a four-week program, offline. Detailed information about FRT exercises in the form of a PDF file, educational videos related to the exercises suitable for Persian speakers and a file related to common questions and answers prepared in advance by researchers and under the supervision of experts, are presented to the participants via social network. On the first day of the treatment period, all this information and videos related to the treatment are provided to the participants. After receiving information about the exercises and watching the initial videos, the participants will perform the exercises related to their treatment plan according to the provided program. Daily exercises for the FRT group will include 4 meals of 4-minute (twice in the morning and twice in the afternoon).</i_keyword>
      <i_keyword>Control group: No treatment. The control group will not receive any treatment program during the study period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Voice Handicap index. Timepoint: One week before treatment. Method of measurement: Self-evaluation by the participant.</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>2023-08-01</approval_date>
        <contact_name>Joint Organizational Ethics Committee of Nursing and Midwifery Faculty and Rehabilitation Faculty of</contact_name>
        <contact_address>Secretariat of Ethics Committee in Biomedical Research, University of Tehran, Keshavarz Blvd., Intersection of Quds St., Central Building of Tehran University of Medical Sciences, 6th Floor, Room 604 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
