<?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>IRCT20220417054566N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-17</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>telepractice versus in-person treatment of voice disorders</public_title>
      <acronym></acronym>
      <scientific_title>the effect of tele-voice therapy in comparison with in-person treatment on the acoustic, perceptual and aerodynamic characteristics of voice in voice-actors.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>14</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63265</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>voice disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: in-person. This group will undergo 18 one-hour treatment sessions. Treatment for this group will include: breathing exercises, head and neck exercises, warming up and cooling down, and voice hygiene counseling Which will be performed at the speech therapy clinic of Iran University of medical sciences. Intervention 2: Intervention group2: online. This group will undergo 18 one-hour treatment sessions. Treatment for this group will include: breathing exercises, head and neck exercises, warming up and cooling down, and voice hygiene counseling Which will be performed on Skype software.</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:
Some of the participants' personal data related to the main outcome will be shared with the researchers in the form of articles and dissertations.

When:
Access after publishing the results in the form of an article.

To whom:
voice disorders researchers

Conditions:
For use in similar research

Where to obtain:
Sadaf Salehi
Email: gooshmahiam@gmail.com

How to obtain:
Request to be approved by the scientific supervisor of this research - Dr. Leila Ghelichi

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sadaf Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.46 Izadi street, Gisha, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1447833431</zip>
        <telephone>+98 930 890 4683</telephone>
        <email>gooshmahiam@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Ghelichi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirdamad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14477833431</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>lghelichi@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The participant is in the age range of 20 to 48 years.
The participant reports at least one voice complaint.
The participant has no previous history of voice therapy.
The participant does not have a history of head and neck surgery.
The participant has enough vision to watch videos and make video calls.
The participant did not have a cold, flu, or airway infection during the sampling or two weeks before.
The participant must have at least 4 years of full-time voice acting experience.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>48 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The reluctance of the participant to continue cooperation with the research group
Failure to record a good sample for voice analysis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R49</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Voice and resonance disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: in-person. This group will undergo 18 one-hour treatment sessions. Treatment for this group will include: breathing exercises, head and neck exercises, warming up and cooling down, and voice hygiene counseling Which will be performed at the speech therapy clinic of Iran University of medical sciences.</i_keyword>
      <i_keyword>Intervention group2: online. This group will undergo 18 one-hour treatment sessions. Treatment for this group will include: breathing exercises, head and neck exercises, warming up and cooling down, and voice hygiene counseling Which will be performed on Skype software.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fundamental frequency. Timepoint: before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention. Method of measurement: praat software.</prim_outcome>
      <prim_outcome>Jitter. Timepoint: before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention. Method of measurement: praat software.</prim_outcome>
      <prim_outcome>Shimmer. Timepoint: before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention. Method of measurement: praat software.</prim_outcome>
      <prim_outcome>Harmonic to noise ratio. Timepoint: before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention. Method of measurement: praat software.</prim_outcome>
      <prim_outcome>Maximum phonation time. Timepoint: before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention. Method of measurement: Stopwatch.</prim_outcome>
      <prim_outcome>S to Z ratio. Timepoint: before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention. Method of measurement: Stopwatch.</prim_outcome>
      <prim_outcome>Voice discomfort index. Timepoint: before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Voice handicap index. Timepoint: before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V). Timepoint: before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention. Method of measurement: persian version of cape-5.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-12</approval_date>
        <contact_name>The Iran University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Tehran Hemat Highway next to Milad Tower، 14535 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
