<?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>IRCT20250210064698N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-18</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of chest physiotherapy on respiratory function after chest trauma</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Incentive Spirometry and Respiratory Physiotherapy on Improving Respiratory Function in Patients Following Chest Injuries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81956</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, a restricted randomization method of block randomization with a ratio of 1:1 and a block size of four was used. Random allocation software version 2.0 was used to randomize the samples. In addition to simple randomization, this software was able to generate a random sequence using the block method, and as a result, this software was used for randomization simultaneously with blocking the samples. In order to maintain homogeneity of sample distribution and the frequency of chest injuries (penetrating and non-penetrating), the control and intervention groups included 18 patients with non-penetrating injuries and 14 patients with penetrating injuries to the chest, Blinding description: In order to blind the study, a statistician independent of the study was responsible for the random assignment of participants to each of the two groups and the final analysis of the data. As a result, one-way blinding was utilized in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: lung contusion. Condition 2: rib fracture. Condition 3: pneumothorax. Condition 4: hemothorax.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The correct method of incentive spirometry involves placing the patient in a semi-sitting position and maintaining a deep breath for a maximum of 2 to 3 seconds and then exhaling. This process was performed daily for at least one hour for three consecutive days, 10 times a day in the intervention group. Respiratory physiotherapy exercises along with deep breathing were performed based on a fixed schedule and under the supervision of two trained nurses in both groups. Intervention 2: Control group: Respiratory physiotherapy exercises along with deep breathing were performed based on a fixed schedule and under the supervision of two trained nurses.</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:
All data from the study, study protocol, statistical analysis map, statistical analysis form, patient consent form, clinical study report, and codes used in data analysis were used in the student thesis of Dr. Lotf Mohammadi and the published article at the end of the study, and will be visible on the website of the Department of General Surgery of Kerman University of Medical Sciences in the student theses section after 6 months from the publication of the article.

When:
The data access period begins 6 months after the results are published.

To whom:
The data will be accessible to the public after obtaining permission from the Vice Chancellor for Research and the Ethics Committee of Kerman University of Medical Sciences.

Conditions:
The data will be available for use by other researchers for statistical analysis and use in other research after obtaining permission from the Vice President for Research and the Ethics Committee of Kerman University of Medical Sciences.

Where to obtain:
To receive the data, an electronic letter should be sent to the Vice Chancellor for Research of the university, and after approval by the Vice Chancellor and the Ethics Committee, to the person in charge of the above research, Dr. Firoozeh Abolhasani, at the email address firoozeh1981@gmail.com, and the data request should be emailed along with the relevant permissions for the data request. People outside the country can contact the university's Vice President for Research by email.

How to obtain:
To receive the data, an electronic letter should be sent to the Vice Chancellor for Research of the university, and after approval by the Vice Chancellor and the Ethics Committee, to the person in charge of the above research, Dr. Firoozeh Abolhasani, at the email address firoozeh1981@gmail.com, and the data request should be emailed along with the relevant permissions for the data request. People outside the country can contact the university's Vice President for Research by email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Firoozeh Abolhasanizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qarni Street - Shahid Bahonar Hospital</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7613747181</zip>
        <telephone>0098 34 7613747181</telephone>
        <email>firoozeh1981@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Firoozeh Abolhasanizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qarni Street - Shahid Bahonar Hospital</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7613747181</zip>
        <telephone>+98 34 3223 5011</telephone>
        <email>firoozeh1981@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients admitted to Shahid Bahonar Hospital in Kerman with chest injuries and requiring chest intubation during the study period in 1402
Age range between 18 and 65 years
Be alert with GCS 15
The maximum injury severity score is 11.
Non-penetrating injury with fracture of more than one rib</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
Decreased alertness
Chronic obstructive pulmonary disease and asthma
History of heart disease
Venous obstruction
Coagulation problems after abdominal and thoracic or brain and eye surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S27.32</hc_code>
      <hc_code>S22.4</hc_code>
      <hc_code>S27.0</hc_code>
      <hc_code>S27.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Contusion of lung</hc_keyword>
      <hc_keyword>Multiple fractures of ribs</hc_keyword>
      <hc_keyword>Traumatic pneumothorax</hc_keyword>
      <hc_keyword>Traumatic hemothorax</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The correct method of incentive spirometry involves placing the patient in a semi-sitting position and maintaining a deep breath for a maximum of 2 to 3 seconds and then exhaling. This process was performed daily for at least one hour for three consecutive days, 10 times a day in the intervention group. Respiratory physiotherapy exercises along with deep breathing were performed based on a fixed schedule and under the supervision of two trained nurses in both groups.</i_keyword>
      <i_keyword>Control group: Respiratory physiotherapy exercises along with deep breathing were performed based on a fixed schedule and under the supervision of two trained nurses.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood oxygen saturation. Timepoint: Before and after the three-day intervention (days one and three). Method of measurement: ABG laboratory test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hemothorax; pneumothorax; atelectasis; pneumonia. Timepoint: Third day after the intervention. Method of measurement: Spiral Chest CT-Scan.</sec_outcome>
      <sec_outcome>Arterial pressure of O2 (PaO2). Timepoint: Before and after the three-day intervention (days one and three). Method of measurement: ABG laboratory test.</sec_outcome>
      <sec_outcome>Arterial pressure of CO2 (PaCO2). Timepoint: Before and after the three-day intervention (days one and three). Method of measurement: ABG laboratory test.</sec_outcome>
      <sec_outcome>Arterial blood pH. Timepoint: Before and after the three-day intervention (days one and three). Method of measurement: ABG laboratory test.</sec_outcome>
      <sec_outcome>FVC. Timepoint: Before and after the three-day intervention (days one and three). Method of measurement: Pulmonary function test.</sec_outcome>
      <sec_outcome>FEV1. Timepoint: Before and after the three-day intervention (days one and three). Method of measurement: Pulmonary function test.</sec_outcome>
      <sec_outcome>FEV1/FVC. Timepoint: Before and after the three-day intervention (days one and three). Method of measurement: Pulmonary function test.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-26</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Shadid Bahonar Hospital kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
