<?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>IRCT20210423051056N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-18</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The combined effect of deep breathing and prone position on common respiratory symptoms in patients with COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>The combined effect of deep breathing and prone position on common respiratory symptoms in patients with COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56733</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block random allocation will be done in such a way that according to the number of study groups (three groups) including intervention 1 (deep breathing), intervention 2 (prone position) and intervention 3 (combination of deep breathing and prone position) And according to the calculated factorial law, ie 6 = 1 + 2 + 3 =! 3, all possible arrangements of individuals considering A for the intervention group 1 (deep breathing), B for the intervention group 2 (prone position) And C will be developed for intervention group 3 (combination of deep breathing and prone position).
Then, since the estimated sample size was 96 people, in each block, three samples, each of which represents a study group and their order of arrangement will be different, from these blocks, sampling will be done by placement.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: deep breathing: This intervention will be taught individually and orally by the researcher. In this way, the patient will be asked to perform the inhalation and exhalation operation in a ratio of 4 to 6, ie the inhalation operation through the nose and counting 1 to 4, and the exhalation operation through the mouth and counting 1 to 6. This training will be done face to face and numbers will be used to maintain the time to exhale ratio. A written guide will also be provided to patients. The training will last for 10 minutes and includes; 1. Place your tongue motionless in the palm of your mouth. 2. Breathe slowly and deeply and regularly (deep and slow inhale, exhale, rest.) And 3. Do not talk during the procedure, it will be. The skill of the samples in performing the exercises will be evaluated by the researcher and after training the patient will be asked to practice this task in order to achieve sufficient skills in this field. Intervention 2: Intervention group 2: prone position: The procedure for performing the intervention in the supine group will be that the patients will first be in the supine position for 30 minutes and before changing the position, the respiratory symptoms will be measured and recorded. The patient will then lie on his stomach or back for 30 minutes and the respiratory symptoms will be re-measured at 15 and 30 minutes. For more accuracy, respiratory symptoms will be measured 3 times at 15-second intervals each time the measurement will be recorded as the desired value. Intervention 3: Intervention group 3: combination of deep breathing and prone position: The intervention will be performed in the group of deep breathing and supine position in combination, as in the previous two groups and in combination.</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>Sima Alipour Nasrabadsofla</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Jalil Hospital, Qarani Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591833769</zip>
        <telephone>+98 74 3333 7001</telephone>
        <email>simaalipour90@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sima Alipour Nasrabadsofla</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Jalil Hospital, Qarani Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591833769</zip>
        <telephone>+98 74 3333 7001</telephone>
        <email>simaalipour90@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 to 85 years
Ability to communicate and answer questions
Consent to participate in the study and sign the informed consent form
The patient is alert
The patient should not be intubated
The percentage of oxygen saturation of the patient's blood is below 93%</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient dissatisfaction with continuing the study
Adverse changes in vital signs (blood oxygen saturation level, heart rate, respiration and blood pressure)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>u07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>U07.1: COVID-19, Virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: deep breathing: This intervention will be taught individually and orally by the researcher. In this way, the patient will be asked to perform the inhalation and exhalation operation in a ratio of 4 to 6, ie the inhalation operation through the nose and counting 1 to 4, and the exhalation operation through the mouth and counting 1 to 6. This training will be done face to face and numbers will be used to maintain the time to exhale ratio. A written guide will also be provided to patients. The training will last for 10 minutes and includes; 1. Place your tongue motionless in the palm of your mouth. 2. Breathe slowly and deeply and regularly (deep and slow inhale, exhale, rest.) And 3. Do not talk during the procedure, it will be. The skill of the samples in performing the exercises will be evaluated by the researcher and after training the patient will be asked to practice this task in order to achieve sufficient skills in this field.</i_keyword>
      <i_keyword>Intervention group 2: prone position: The procedure for performing the intervention in the supine group will be that the patients will first be in the supine position for 30 minutes and before changing the position, the respiratory symptoms will be measured and recorded. The patient will then lie on his stomach or back for 30 minutes and the respiratory symptoms will be re-measured at 15 and 30 minutes. For more accuracy, respiratory symptoms will be measured 3 times at 15-second intervals each time the measurement will be recorded as the desired value.</i_keyword>
      <i_keyword>Intervention group 3: combination of deep breathing and prone position: The intervention will be performed in the group of deep breathing and supine position in combination, as in the previous two groups and in combination.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dyspnea. Timepoint: Patients' rate of Dyspnea at the beginning of the study (before the intervention) and immediately after the start of the study. Method of measurement: Borg's Category Ratio Scale ( CR10 ) and Visual Analog Scales ( VAS).</prim_outcome>
      <prim_outcome>Cough. Timepoint: Number of patients coughing at the beginning of the study (before the intervention) and immediately after the start of the study. Method of measurement: Record the number of coughs using a checklist prepared by the researcher.</prim_outcome>
      <prim_outcome>Breathing. Timepoint: The number of patients breathing at the beginning of the study (before the intervention) and immediately after the start of the study. Method of measurement: Record the number of breathing using a checklist prepared by the researcher.</prim_outcome>
      <prim_outcome>Blood oxygen saturation level. Timepoint: Percentage of blood oxygen saturation of patients at the beginning of the study (before the intervention) and immediately after the start of the study. Method of measurement: Pulse oximeter connected to the monitor model LK88.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-15</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
