<?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>IRCT20241101063561N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-02</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of breathing and stretching exercises on Oxygen saturation of venous blood, Length of hospitalization and Resilience of patients with chest tubes after chest trauma</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of breathing and stretching exercises on Oxygen saturation of venous blood, Length of hospitalization and Resilience of patients with chest tubes after chest trauma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81648</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the present study, the permutation block method will be used to collect the sample. Random allocation by permutation block method is listed in 7 blocks of 12 with Random Allocation Software.
The statistical consultant of the Faculty of Nursing and Midwifery of Shiraz University of Medical Sciences determines the random allocation sequence and the researcher (student) enters the participants and allocates them to the intervention group based on the entry and exit criteria.
In order to conceal, there will be no physical contact between the participants using the distribution method and training the participants at different times to prevent bias, Blinding description: In this study, the person collecting the data and the person analyzing the data are blinded to the groups until the end of the work.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chest trauma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Breathing and stretching exercise programs including chest physiotherapy and pursed lip breathing and motor training interventions such as upper limb motor exercises will be performed at the patient's bedside by the principal investigator and a physiotherapist as a research assistant (a person who has been trained and approved). Professors of the Faculty of Rehabilitation, Shiraz University of Medical Sciences) and an ICU man. Participants will perform these exercises up to 10 times in one hour, depending on their ability and clinical conditions. This activity will be performed three times a day for one hour at 9 am, 3 pm and 9 pm, and the researcher and research assistant will monitor its accuracy. All training will be provided to patients in person and practically. Then, before the intervention, one and three days after the intervention, blood oxygen saturation will be measured and recorded. Also, before, one day after the intervention, and three days after the intervention, a resilience questionnaire will be completed by all patients. The duration of the patients' hospitalization will be assessed and recorded. Intervention 2: Control group: The control group will be placed under routine care for patients with chest tubes after chest trauma. Then, blood oxygen saturation will be measured and recorded before the intervention, one and three days after the intervention. Also, a resilience questionnaire will be completed by all patients before, one day after the intervention, and three days after the intervention. The duration of hospitalization of the patients will be assessed and recorded. It should be noted that after the end of the study, educational videos on breathing and stretching exercises will also be made available to the 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After the end of the study, it is possible to share the data.

When:
After the end of the study, it is possible to share data for one year.

To whom:
Researchers working in academic and scientific institutions of medical sciences.

Conditions:
Analysis on documents and data is allowed.

Where to obtain:
Dr. Khatereh Rostami is responsible for this project. Phone Number: +98 71 3647 4254 Address: Hazrat Fatemeh College of Nursing and Midwifery, Entrance to Namazi Hospital, Namazi Square, Shiraz, Fars Province Email: khatereh.rostami.nursing@gmail.com

How to obtain:
In order to access the information of the study, first of all, contact should be made with the manager of this project, Dr. Khatereh Rostami, whose profile is attached below, and then after reviewing the relevant request and meeting the requirements, the documents will be sent as soon as possible. Phone: +98 71 3647 4254 Address: Fars Province, Shiraz, Namazi Square, the entrance of Namazi Hospital, Hazrat Fatima College of Nursing and Midwifery Email: khatereh.rostami.nursing@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khatereh Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatimah School of Nursing and Midwifery, Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>khatereh.rostami.nursing@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khatereh Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatimah School of Nursing and Midwifery, Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>khatereh.rostami.nursing@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult patients aged 18 to 40 years with a unilateral chest tube after chest trauma
Participants should be aware of place, time, and person
No history of smoking or other drug use
Absence of respiratory diseases such as lung cancer, asthma, and chronic obstructive pulmonary disease
Ability to perform breathing and stretching exercises
Willingness to participate in research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe head, spinal cord, or abdominal injuries in the same trauma
Patients who have medical contraindications to chest tube removal, such as persistent air leaks or severe pneumothorax
Having a mental disorder (psychosis, major depression, bipolar disorder, and Alzheimer's disease, as reported by the patient or the patient's companion)
Patients who are pregnant or breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S27.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury of unspecified intrathoracic organ</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: Breathing and stretching exercise programs including chest physiotherapy and pursed lip breathing and motor training interventions such as upper limb motor exercises will be performed at the patient's bedside by the principal investigator and a physiotherapist as a research assistant (a person who has been trained and approved). Professors of the Faculty of Rehabilitation, Shiraz University of Medical Sciences) and an ICU man. Participants will perform these exercises up to 10 times in one hour, depending on their ability and clinical conditions. This activity will be performed three times a day for one hour at 9 am, 3 pm and 9 pm, and the researcher and research assistant will monitor its accuracy. All training will be provided to patients in person and practically. Then, before the intervention, one and three days after the intervention, blood oxygen saturation will be measured and recorded. Also, before, one day after the intervention, and three days after the intervention, a resilience questionnaire will be completed by all patients. The duration of the patients' hospitalization will be assessed and recorded.</i_keyword>
      <i_keyword>Control group: The control group will be placed under routine care for patients with chest tubes after chest trauma. Then, blood oxygen saturation will be measured and recorded before the intervention, one and three days after the intervention. Also, a resilience questionnaire will be completed by all patients before, one day after the intervention, and three days after the intervention. The duration of hospitalization of the patients will be assessed and recorded. It should be noted that after the end of the study, educational videos on breathing and stretching exercises will also be made available to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Venous blood oxygen saturation. Timepoint: Before, one and three days after the breathing and stretching exercises intervention. Method of measurement: Richter finger pulse oximeter, model Ri-Fox N 1905, for each patient before, one and three days after chest tube placement (the calibration of the device will be approved by the medical engineering expert of Shahid Rajaee and Namazi Hospital.).</prim_outcome>
      <prim_outcome>Duration of hospitalization. Timepoint: Before, one and three days after the breathing and stretching exercises intervention. Method of measurement: The number of days is from the first day of hospitalization to the time of discharge, calculated based on the dates in the patient's hospital record.</prim_outcome>
      <prim_outcome>Resilience. Timepoint: Before, one and three days after the breathing and stretching exercises intervention. Method of measurement: The patient's level of resilience in this study is a score obtained from completing the Connor Davidson questionnaire before, one and three days after the intervention. This questionnaire has 25 questions and its aim is to measure the level of resilience in different individuals. To obtain the overall score of the questionnaire, the total scores of all questions are added together, this score will have a range from 0 to 100. The higher this score, the greater the level of resilience of the respondent and vice versa. This questionnaire has been validated in different populations and environments and has good reliability and validity. This questionnaire is completed before, three and seven days after the intervention.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-09-28</approval_date>
        <contact_name>Research Ethics Committees of Schools of Nursing and Midwifery, Management and Medical Information s</contact_name>
        <contact_address>Hazrat Fatemeh College of Nursing and Midwifery, Entrance to Namazi Hospital, Namazi Square, Shiraz, Fars Province Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
