<?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>IRCT20181017041374N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-27</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Buteyko Breathing Retraining on Respiratory Indices, activity and anxiety level, in Patients with Anxiety Disorder - A Randomized controlled Trial</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Buteyko Breathing Retraining on Respiratory Indices, activity and anxiety level, in Patients with Anxiety Disorder - A Randomized controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35027</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, patients who are referred to the Rehabilitation Clinic will be selected by individuals who have been homogenized in the genus and body mass; individuals are classified according to normal BMI (25), overweight (25 to 29.99), and obese (30 ≤) And then the same couples will be split into an accident between the two groups, Blinding description: Participants and researcher in the study will be blind in intervention groups, and the individuals in each treatment group will not be aware of the other group.</study_design>
      <phase>3</phase>
      <hc_freetext>Patients with General Anxiety disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Individuals with anxiety disorder are treated under the medication and routine counseling, which is referred to as intervention group by training exercises based on biteic breathing techniques and respiratory pattern correction. Medication is prescribed by a physician. Intervention 2: Control group: Anxious patients are treated under the medication and routine counseling, which are considered as a control 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>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 Sampling is not over yet and will be completed if the study is completed.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapour University of Medical Science, Golestan, Ahvaz city, khozestan province</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0051742675</zip>
        <telephone>+98 61 3374 3101</telephone>
        <email>maleki.a@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapour University of Medical Science, Golestan, Ahvaz city, khozestan province</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0051742675</zip>
        <telephone>+98 61 3374 3101</telephone>
        <email>maleki.a@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with anxiety disorder diagnosed by a physician
Not having any illness or musculoskeletal-musculoskeletal system interfering with breathing and based on the examination and evaluation that the investigator will examine.
Not having addiction to any drugs or cigarettes and alcohol
Have a high school diploma degree
The company does not have to do any physical or sporting activities professionally and earn points from the Beck Action Level Questionnaire.
No breathing exercises have been performed, such as Buteyko exercises or other exercises
Individuals with respiratory pattern of hyperventilation, who were evaluated by a semiann questionnaire score 23 to 64 to enter the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>In case of unwillingness and tolerance of treatment intervention
Pulse of heart over normal range based on age
The presence of any problems with the upper airways, including polyps, and the deviation of the nasal blades that lead to breathing through the mouth and preventing breathing. This criterion is made through the rapid and common tests in the auditory services of the ENT and by the research team.
Any dizziness and headache or nausea during or after exercise
Excessive concern during the implementation of the project in such a way that the process of conducting research is compromised
Cardiovascular disease based on self-expression
Mentally retarded patients
Pregnant</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Individuals with anxiety disorder are treated under the medication and routine counseling, which is referred to as intervention group by training exercises based on biteic breathing techniques and respiratory pattern correction. Medication is prescribed by a physician.</i_keyword>
      <i_keyword>Control group: Anxious patients are treated under the medication and routine counseling, which are considered as a control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>GAD-7 and Beck Anxiety Qًuestionnaire Scores. Timepoint: At the beginning of the intervention, during the study, approximately 4 weeks later, and at the end of the study, 8 weeks later. Method of measurement: Beck and GAD-7 Anxiety Inventory and Nigmegen Respiratory Function Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Forced Expiratory Volume in First second. Timepoint: Baseline and one month and two months later. Method of measurement: spirometry.</sec_outcome>
      <sec_outcome>Forced Vital Capacity. Timepoint: Baseline and one month and two months later. Method of measurement: spirometry.</sec_outcome>
      <sec_outcome>Ratio between Forced Expiratory Volume in First second/Forced Vital Capacity. Timepoint: Baseline and one month and two months later. Method of measurement: spirometry.</sec_outcome>
      <sec_outcome>End tidal volume Expiratory carbon dioxide pressure. Timepoint: Baseline and one month and two months later. Method of measurement: Capnometry.</sec_outcome>
      <sec_outcome>Heart Rate. Timepoint: Baseline and one month and two months later. Method of measurement: Capnometry.</sec_outcome>
      <sec_outcome>Respiratory Rate. Timepoint: Baseline and one month and two months later. Method of measurement: Capnometry.</sec_outcome>
      <sec_outcome>Respiratory function questionnaire score - Nijmegen. Timepoint: Baseline and one month and two months later. Method of measurement: Nijmegen questionnaire.</sec_outcome>
      <sec_outcome>Beck Anxiety Inventory. Timepoint: Baseline and one month and two months later. Method of measurement: Beck Anxiety Inventory.</sec_outcome>
      <sec_outcome>General Anxiety Disorder Questionnaire score. Timepoint: Baseline and one month and two months later. Method of measurement: General Anxiety Disorder Questionnaire      GAD-7.</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>2019-04-09</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ahvaz Jundishapour University of Medical science                   Golestan boulvar, Ahvaz city, khozestan province Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
