<?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>IRCT20231024059840N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-07</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effectiveness of resonant voice therapy and manual circumlaryngeal therapy on laryngeal tension</public_title>
      <acronym>RVT</acronym>
      <scientific_title>Comparing the effectiveness of resonant voice therapy and manual circumlaryngeal therapy on tension reduction in patients with primary muscle tension dysphonia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74610</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: One of the therapeutic methods used in this research (resonant voice therapy) requires designing assignments in Persian language. Therefore, one of the products of this research is the design and preparation of valid and reliable tasks in Persian language, Randomization description: Randomization method: Randomization will be done using block, in such a way that all two people who enter the study will be placed in two treatment groups using lottery. The randomization unit is individual. Randomization tool using lottery, Blinding description: The evaluators (speech therapists other than the researcher) who evaluate the patients on 4 occasions during the study are blinded to the treatment that the patients receive. Also, the patients do not know what treatments are offered in this study, and the researcher is also blind to the patients' evaluation reports (the reports are coded).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Muscle tension dysphonia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: resonant voice therapy: This treatment method consists of 7 steps during which the patient learns how to produce resonant voice and how to use it in speech.The duration of the treatment consists of 6 sessions of 30 minutes, which are held twice a week. Intervention 2: Intervention group: manual circumlaryngeal therapy : In the MCT method, the patient sits on a comfortable chair; The therapist is placed next to the patient and manual therapy is performed with the therapist's superior hand and thumb and index (or middle) finger. Manual treatment starts from the target points where the patient has less pain and discomfort, but the parts that have more pain and discomfort; More attention is paid. The target points in this method are:1.hyoid bone 2. Thyrohyoid space 3. The posterior border of the thyroid lamina 4. Middle and lateral suprahyoid muscles.duration of the treatment consists of 6 sessions of 30 minutes, which are held twice a week.</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:
The results of evaluations and statistical data and the results of statistical analyzes will be published in articles and thesis text.

When:
6 months after printing the results

To whom:
Researchers working at Tehran University of Medical Sciences

Conditions:
If the researchers of Tehran University of Medical Sciences conduct a study in the common field with the present plan, they can use the documents

Where to obtain:
Dr. Maryam Khodami, Faculty of Rehabilitation, Tehran University of Medical Sciences

How to obtain:
By using the application letter in which a brief description of the research is mentioned so that their research is related to the current research.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojdeh mohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelan ave. Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 912 929 3894</telephone>
        <email>mmojdeh92@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojdeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 912 929 3894</telephone>
        <email>mmojdeh92@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>According to the joint opinion of a laryngologist and an experienced speech and language pathologist in the field of voice disorders, and based on the results of voice history, voice self-evaluation, larynx observation, auditory-perceptual evaluation of voice and palpation, the participants will receive a primary MTD diagnosis.
Be in the age range of 18 to 55 years
Have normal hearing
Do not have evidence of neurological diseases
Do not have a history of other voice disorders (such as weakness and paralysis of the vocal folds or laryngeal cancer).
do not have a history of surgery, radiation therapy, trauma and intubation in the larynx and neck, chronic pain in the neck area, burns of the head and neck, and any kind of scar in the front of the neck and around the larynx.
At least 14 days before the start of the study,  do not have an active infection in the larynx and upper respiratory tract
At the time of the study and before that, they have not received any other voice therapy program
do not have a fat and short neck so that it is possible to perform a palpation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>have not completed any of the assessment and treatment stages of the study
Their audio samples are unanalyzable for any reason
In the evaluation of the palpation of all the target structures, the score of muscle tension should be reported as zero</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: resonant voice therapy: This treatment method consists of 7 steps during which the patient learns how to produce resonant voice and how to use it in speech.The duration of the treatment consists of 6 sessions of 30 minutes, which are held twice a week.</i_keyword>
      <i_keyword>Intervention group: manual circumlaryngeal therapy : In the MCT method, the patient sits on a comfortable chair; The therapist is placed next to the patient and manual therapy is performed with the therapist's superior hand and thumb and index (or middle) finger. Manual treatment starts from the target points where the patient has less pain and discomfort, but the parts that have more pain and discomfort; More attention is paid. The target points in this method are:1.hyoid bone 2. Thyrohyoid space 3. The posterior border of the thyroid lamina 4. Middle and lateral suprahyoid muscles.duration of the treatment consists of 6 sessions of 30 minutes, which are held twice a week</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Muscle tension: The amount of tension of the paralaryngeal muscles, which can be measured by palpation. Timepoint: Muscle tension is measured before the start of the treatment, in the third session of the treatment and at the end of the treatment and one month after the end of the treatment. Method of measurement: Palpation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vocal effort. Timepoint: Voice effort is measured before the start of the treatment, in the third session of the treatment, at the end of the treatment and one month after the end of the treatment. Method of measurement: Vocal effort scale.</sec_outcome>
      <sec_outcome>Cepstral analysis. Timepoint: It is measured before the start of the treatment, in the third session of the treatment and at the end of the treatment and one month after the end of the treatment. Method of measurement: Praat software.</sec_outcome>
      <sec_outcome>Vocal fatigue. Timepoint: It is measured before the start of the treatment, in the third session of the treatment and at the end of the treatment and one month after the end of the treatment. Method of measurement: Vocal fatigue index.</sec_outcome>
      <sec_outcome>Vocal strugle. Timepoint: It is measured before the start of the treatment, in the third session of the treatment and at the end of the treatment and one month after the end of the treatment. Method of measurement: The Consensus Auditory Perceptual Evaluation of Voice.</sec_outcome>
      <sec_outcome>Glottal closure. Timepoint: It is measured before the start of the treatment and at the end of the treatment and one month after the end of the treatment. Method of measurement: Laryngeal stroboscopy and VALI form(form for reporting datas).</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>2024-02-06</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran. Enghelab ave. Rahabilitation school of tehran university of medical science Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
