<?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>IRCT20210303050570N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-17</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of combined treatment of laryngeal manual therapy with Kinesio taping and laryngeal manual therapy alone in improving vocalic symptoms in patients with muscle tension dysphonia.</public_title>
      <acronym>نام اختصاری درمان دستی حنجره یا laryngeal manual therapy ،  سه حرف LMT است. نام اختصاری کینزیوتیپینگ یا Kinesiotaping، دو حرف KT می باشد. نام اختصاری دیسفونی تنش عضلانی یا Muscle tension dysphonia سه حرف MTD می باشد.</acronym>
      <scientific_title>Comparison of the effects of combined treatment of laryngeal manual therapy with Kinesio taping and laryngeal manual therapy alone in improving vocalic symptoms in patients with muscle tension dysphonia : A single-blind randomized controlled trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54798</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, each participant picks up a number between 1 and 20 from the bag. Odd numbers are assigned to group 1 (Laryngeal Manual Therapy) and even numbers are assigned to group 2 (Laryngeal Manual Therapy + Kinesio taping), Blinding description: In this study, participants are kept blind and they were unaware from how to assign to different groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Muscle tension dysphonia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The first intervention group will receive only laryngeal manual therapy. This type of treatment includes strategies to relax the paralaryngeal muscles with excessive stress, to improve the function of the glottal source, which focuses specifically on the sternocleidomastoid muscles at the beginning of treatment and then on the supralaryngeal area.  This group will be treated for 8, 30 minutes sessions and twice a week for a month. Intervention 2: Intervention group 2: In addition to laryngeal manual therapy, this group will be treated with kinesiotaping and tape replacement will be performed each session. kinesio tape will be applied to the sternocleidomastoid muscles, supralarynx and longitudinal muscles of the larynx. The length and frequency of the sessions are the same as the previous group.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maedeh Vahid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Speech therapy, School of Rehabilitation, Semnan University of Medical Sciences, 5th km of Damghan road.</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35131-38111</zip>
        <telephone>+98 23 3344 1022</telephone>
        <email>maedehvahid75@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Banafshe Mansuri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Speech therapy, School of Rehabilitation, Semnan University of Medical Sciences, 5th km of Damghan road.</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35147-99442</zip>
        <telephone>+98 23 3344 1022</telephone>
        <email>slp.banafshe@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>History of sound misuse, psychological problems and stressful situations.
Visible and palpable tension around the larynx, stiffness of the paralaryngeal muscles, swelling of the larynx, and decreased thyrohyoid space</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of performing previous surgeries on the neck
Presence of hormonal disorders
Menopause in females
History of epileptic and seizure problems</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: The first intervention group will receive only laryngeal manual therapy. This type of treatment includes strategies to relax the paralaryngeal muscles with excessive stress, to improve the function of the glottal source, which focuses specifically on the sternocleidomastoid muscles at the beginning of treatment and then on the supralaryngeal area.  This group will be treated for 8, 30 minutes sessions and twice a week for a month.</i_keyword>
      <i_keyword>Intervention group 2: In addition to laryngeal manual therapy, this group will be treated with kinesiotaping and tape replacement will be performed each session. kinesio tape will be applied to the sternocleidomastoid muscles, supralarynx and longitudinal muscles of the larynx. The length and frequency of the sessions are the same as the previous group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Acoustic features of patients with muscle tension dysphonia. Timepoint: Before and immediately after treatment. Method of measurement: Acoustic evaluations of the voice, auditory perceptual evaluations of the voice.</prim_outcome>
      <prim_outcome>Vocal tract discomfort. Timepoint: Before and immediately after treatment. Method of measurement: Vocal tract discomfort (VTD) scale.</prim_outcome>
      <prim_outcome>Severity and frequency of pain. Timepoint: Before and immediately after treatment. Method of measurement: Voice related pain scale.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-27</approval_date>
        <contact_name>Ethics committee in research of Semnan University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Headquarters of Semnan University of Medical Sciences, Amirkabir Square Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
