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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

Protocol summary

Study aim
Determining the effect of breathing and stretching exercises on venous blood oxygen saturation, length of hospitalization, and resilience of patients with chest tubes after chest trauma
Design
This is a randomized controlled clinical trial (with a permutation block design) with two parallel groups and double-blinded.
Settings and conduct
This double-blind study includes adult trauma patients (accidents, assaults, falls) hospitalized in emergency and special wards of Shahid Rajaee and Namazi Hospitals, Shiraz University.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Participants must be aware of the place, time, and person; no history of smoking or drugs; no history of respiratory diseases such as lung cancer, asthma, and chronic obstructive pulmonary disease; ability to perform breathing and stretching exercises; willingness to participate in the study. Exclusion criteria: severe head, spinal cord, or abdominal injuries in the same trauma; patients with medical contraindications to chest tube removal, such as persistent air leaks or severe hemothorax; psychiatric disorders (psychosis, major depression, bipolar disorder, and Alzheimer's disease reported by the patient or caregiver); patients who are pregnant or breastfeeding.
Intervention groups
Intervention: A researcher and physiotherapist will conduct breathing and stretching exercises three times daily for three days. Control: A chest trauma group with a unilateral chest tube will receive standard treatment. Blood oxygen saturation, resilience (questionnaire), and hospitalization duration will be measured before, one day after, and three days post-intervention.
Main outcome variables
blood oxygen saturation, hospitalization duration, and patient resilience

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241101063561N3
Registration date: 2025-02-02, 1403/11/14
Registration timing: prospective

Last update: 2025-02-02, 1403/11/14
Update count: 0
Registration date
2025-02-02, 1403/11/14
Registrant information
Name
khatereh rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
khatereh.rostami.nursing@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-04-19, 1404/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
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
Purpose
Supportive
Inclusion/Exclusion 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
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
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Schools of Nursing and Midwifery, Management and Medical Information s
Street address
Hazrat Fatemeh College of Nursing and Midwifery, Entrance to Namazi Hospital, Namazi Square, Shiraz, Fars Province
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2024-09-28, 1403/07/07
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1403.101

Health conditions studied

1

Description of health condition studied
chest trauma
ICD-10 code
S27.9
ICD-10 code description
Injury of unspecified intrathoracic organ

Primary outcomes

1

Description
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.)

2

Description
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.

3

Description
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.

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Rehabilitation

2

Description
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.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Ahmad Hossein Zadeh
Street address
Namazi Hospital, Namazi Square, Zand Street, Shiraz, Fars
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
nemazee_inf@sums.ac.ir

2

Recruitment center
Name of recruitment center
Emtyaz Hospital (Rajaee Hospital)
Full name of responsible person
Hossein Ali Khalili
Street address
Haj Mohammad Esmaeil Imtiaz Hospital and Shahid Rajaee Surgical Emergencies, before reaching Niayesh Boulevard, Shahid Chamran Boulevard, Shiraz
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
rajaeehospital@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
7th Floor, Shiraz University of Medical Sciences Central Building, next to the Red Crescent, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khatereh Rostami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fatimah School of Nursing and Midwifery, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
khatereh.rostami.nursing@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khatereh Rostami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fatimah School of Nursing and Midwifery, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
khatereh.rostami.nursing@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khatereh Rostami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fatimah School of Nursing and Midwifery, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
khatereh.rostami.nursing@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the end of the study, it is possible to share the data.
When the data will become available and for how long
After the end of the study, it is possible to share data for one year.
To whom data/document is available
Researchers working in academic and scientific institutions of medical sciences.
Under which criteria data/document could be used
Analysis on documents and data is allowed.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
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
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