<?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>IRCT2017100736611N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-15</date_registration>
      <primary_sponsor>Shahrekord Medical Sciences University</primary_sponsor>
      <public_title>The effect of breathing intervention on anxiety and physiological parameters</public_title>
      <acronym></acronym>
      <scientific_title>The effect of breathing intervention on anxiety and physiological parameters of hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27313</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic kidney disease - hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: This is a single-blind clinical trial that was done In the experimental group, these exercises were performed in 3 stages. The nurse's guidance was performed in three ways and in three stages as follows:&#13;
1) Respiratory training was provided to nurses individually (face to face) for 10 minutes.&#13;
2) The instructions for the respiratory program (adequate abdominal respiration, respiratory rate, body condition, and abdominal contraction and expansion along the tail and exhalation) were broadcast through the audio device for 10 minutes. Then, in the music background, the patients with the speaker's guidance Or the nurse (2, 3, 4 and breath 2, 3, 4, and breath .....) breathed deeply and slowly.&#13;
3) In the next step, the patients performed respiratory exercises under direct guidance of the nurse for 30 minutes (2).&#13;
At the first session, all three stages were supervised by the nurse. In the next sessions of the last stage, it was done by the nurse's indirect care for breathing exercises. Of course, at each training session, the nurse should make sure that the patient learned the exercises and performed properly. Also, the patient did not sleep during the training. Intervention 2: The control group received usual care.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>fatemeh seife</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdi Complex Unit 6, Alley 27, Bozorgmehr Street, Mirabad, Shah-re-kord</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 38 3338 3586</telephone>
        <email>st-seife.f@skums.ac.ir; fatemeh.seife@gmail.com‏</email>
        <affiliation>School of Nursing, Shahrekord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>fatemeh aliakbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Somayeh Avenue, Teachers Street, Shahr-e-Kord</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 38 3333 5648</telephone>
        <email>aliakbari.f@skums.ac.ir; aliakbarifa@gmail.com</email>
        <affiliation>Faculty of Nursing, University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Chronic kidney disease and hemodialysis, two or three sessions, per week; age 18 and above; non-acute hearing impairment; hemodialysis for more than three months; lack of mental disorders confirmed by a psychiatrist; It lacks the underlying condition of the respiratory system that makes it difficult for the patient to perform breathing exercises and tends to participate in the study. (Exclusion criteria: if the patient is hospitalized for any reason; absence of regular referral for dialysis during the study period; patient's death).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This is a single-blind clinical trial that was done In the experimental group, these exercises were performed in 3 stages. The nurse's guidance was performed in three ways and in three stages as follows:&#13;
1) Respiratory training was provided to nurses individually (face to face) for 10 minutes.&#13;
2) The instructions for the respiratory program (adequate abdominal respiration, respiratory rate, body condition, and abdominal contraction and expansion along the tail and exhalation) were broadcast through the audio device for 10 minutes. Then, in the music background, the patients with the speaker's guidance Or the nurse (2, 3, 4 and breath 2, 3, 4, and breath .....) breathed deeply and slowly.&#13;
3) In the next step, the patients performed respiratory exercises under direct guidance of the nurse for 30 minutes (2).&#13;
At the first session, all three stages were supervised by the nurse. In the next sessions of the last stage, it was done by the nurse's indirect care for breathing exercises. Of course, at each training session, the nurse should make sure that the patient learned the exercises and performed properly. Also, the patient did not sleep during the training.</i_keyword>
      <i_keyword>The control group received usual care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Situational anxiety. Timepoint: Before and after intervention. Method of measurement: Spielberger's State-Trait Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Physiological parameters. Timepoint: Before and after intervention. Method of measurement: Blood pressure in mm of mercury  Medical barometer and Stethoscope and radial pulse rate measurement and breathing rate for one minute.</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>Shahrekord Medical Sciences University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-06</approval_date>
        <contact_name>Research Deputy of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Research Deputy, University of Medical Sciences, Kashani Street , Shahrekord Shahrekord  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
