<?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>IRCT20171230038149N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-06</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of infrared light and manual therapy</public_title>
      <acronym></acronym>
      <scientific_title>The additional effects of infrared light to manual therapy in people with Muscle tension dysphonia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28835</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: A simple random method, It is written on 10 A4 paper, letter A (to determine the manual treatment group), and 10 other A4 papers B (to determine the manual treatment group and Low-level Laser therapy (LLLT), and each of the references is asked to select one of these two Pick up, Blinding description: Before manual therapy in each session, the patient is asked to lie on the bed and cover his eyes with an blindfold. Two NEW Dual Infrared and Red Light Therapy Speeds Healing 120 leds are placed on the parapharyngeal area on the neck. The devices in manual therapy group is placed on the neck, but the devices is not turned on. Two groups are asked to keep their blindfold. After twenty minutes, both groups receive manual treatment.
Only the therapist is aware of which of the patients receive radiation.
The main investigator is not aware of which of the patients fall into any of the treatment groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Musle tension dysphonia.</hc_freetext>
      <i_freetext>Intervention 1: Control group:  At each of eight treatment sessions, the "control group" is asked to lie on the bed and cover their eyes with blindfolds. Then two infrared devices are placed on the parapharyngeal part of the neck. In the "control group" the device will not be switched and patients will not receive radiation. After 20 minutes, the devices are removed. Then, patients can remove the blindfolds. After this step, the "control group" receives manual therapy. The patient should lie on the bed and the skilled therapist starts the manual therapy. manual therapy includes massages that cause relaxation of the laryngeal muscles and improve the quality of the voice.When the massages is performed, the patient is asked to sustain a vowel and judge the improvement of the quality of the voice. Intervention 2: Intervention group: At each of the eight treatment sessions,the "intervention group" is also asked  to lie on the bed and cover their eyes with an blindfolds. Two devices are placed in the parapharyngeal part of the neck. In the" intervention group", the device is switched and the patient receives infrared radiation. This radiation causes warming and increased blood circulation and removes poisons through sweat. After 20 minutes, the devices are removed. Then, patients can remove the blindfolds. The patient should lie on the bed and the skilled therapist starts the manual therapy. manual therapy includes massages that cause relaxation of the laryngeal muscles and improve the quality of the voice.When the massages is performed, the patient is asked to sustain a vowel and judge the improvement of the quality of the voice.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negin Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Highway</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33133 -61357</zip>
        <telephone>+98 61 3374 3101</telephone>
        <email>Moradi-n@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negin Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Highway</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33133 -61357</zip>
        <telephone>+98 61 3374 3101</telephone>
        <email>Moradi-n@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>diagnosis of Muscle tension dysphonia
pain in the laryngeal region
age&gt;20</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnant
patient with pace maker
Patient with cancer if there is a possibility of metastasis
Epilepsy or seizure
Hormonal disorders
neck vessel problems
History of surgery on the neck or larynx
Cardiovascular problems</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>Control group:  At each of eight treatment sessions, the "control group" is asked to lie on the bed and cover their eyes with blindfolds. Then two infrared devices are placed on the parapharyngeal part of the neck. In the "control group" the device will not be switched and patients will not receive radiation. After 20 minutes, the devices are removed. Then, patients can remove the blindfolds. After this step, the "control group" receives manual therapy. The patient should lie on the bed and the skilled therapist starts the manual therapy. manual therapy includes massages that cause relaxation of the laryngeal muscles and improve the quality of the voice.When the massages is performed, the patient is asked to sustain a vowel and judge the improvement of the quality of the voice.</i_keyword>
      <i_keyword>Intervention group: At each of the eight treatment sessions,the "intervention group" is also asked  to lie on the bed and cover their eyes with an blindfolds. Two devices are placed in the parapharyngeal part of the neck. In the" intervention group", the device is switched and the patient receives infrared radiation. This radiation causes warming and increased blood circulation and removes poisons through sweat. After 20 minutes, the devices are removed. Then, patients can remove the blindfolds. The patient should lie on the bed and the skilled therapist starts the manual therapy. manual therapy includes massages that cause relaxation of the laryngeal muscles and improve the quality of the voice.When the massages is performed, the patient is asked to sustain a vowel and judge the improvement of the quality of the voice.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>First Formant. Timepoint: at the beginning of the study (before the intervention) and at the end of the eighth session and two weeks after the last session. Method of measurement: praat software.</prim_outcome>
      <prim_outcome>Second formant. Timepoint: at the beginning of the study (before the intervention) and at the end of the eighth session and two weeks after the last session. Method of measurement: praat softwave.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-16</approval_date>
        <contact_name>Ethics committee of Jundi shapour University</contact_name>
        <contact_address>Golestan Highway Ahwaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
