- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07549555
Effect of Manual Chest Wall Vibration on Respiratory Function and Chest Tube Duration After Thoracic Surgery
The Effect of Manual Chest Wall Vibration on Respiratory Functions and Chest Tube Duration in Patients Undergoing Thoracic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was conducted to determine the effects of a manual vibration technique applied to the chest wall on the duration of chest tube placement, secretion clearance, and hemodynamic parameters in patients with chest tubes.
Thoracic surgery is a method used in the treatment of diseases of the lungs, pleura, chest wall, and mediastinum. The primary problems encountered by patients postoperatively include improper patient positioning, incision pain, ineffective coughing, reduced lung volume, postoperative pulmonary complications, inadequate airway clearance, frozen shoulder on the side of the thoracotomy, postural abnormalities, and persistent chest wall tension. These issues, particularly pulmonary complications, can delay patient recovery, prolong hospital stays, and increase morbidity and mortality. Tube thoracostomy is a one-way drainage system that facilitates the drainage of fluid and air from the pleural space, maintains negative pressure, and allows for lung expansion. Additionally, it allows for the administration of therapeutic medications into the pleural space. Patients should be educated on respiratory exercises-such as coughing, balloon inflation, and the use of a triflowmeter-to facilitate lung expansion and secretion clearance, and they should be encouraged to perform these exercises regularly. A review of the literature reveals no studies investigating the effectiveness of manual vibration in patients with chest tubes. It is believed that this technique may shorten the duration of chest tube placement. Additionally, due to the lack of cost-effectiveness of mechanical vibration, supply issues, the inability to use it effectively on all patients in clinical settings, the recommendation for more frequent use, and the necessity of applying it based on the patient's needs rather than at regular intervals (such as every two hours)-a determination that must be made by the nurse closely monitoring the patient- it is anticipated that the manual vibration technique will provide greater benefits at regular intervals without incurring additional costs, as it adapts to the patient's needs and the clinic's operational schedule throughout the day.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beyza SU, MSc.
- Phone Number: +905347297580
- Email: beyza.koseoglu.koseoglu@gmail.com
Study Contact Backup
- Name: Sibel YİLMAZ SAHİN, Assoc Prof
- Phone Number: +905353303222
- Email: sibelyilmaz.sahin@sbu.edu.tr
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Recruiting
- Institute of Health Sciences, Saglik Bilimleri University
-
Contact:
- Sibel YİLMAZ SAHİN, Assoc Prof
- Phone Number: +905353303222
- Email: sibelyilmaz.sahin@sbu.edu.tr
-
Principal Investigator:
- Beyza SU, MSc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having undergone thoracic surgery
- Having a chest tube in the postoperative period
- Being hemodynamically stable
- Agreeing to participate in the study
- Being open to communication and cooperation
Exclusion Criteria:
- Severe cardiac instability
- Patients unable to tolerate the procedure due to neurological or cognitive impairment
- Clinical conditions that would prevent the application of vibration to the chest wall
- Patients diagnosed with pneumonia
- Patients with a newly implanted transvenous or subcutaneous pacemaker
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Chest Wall Oscillation Group
Postoperative patients with chest tubes received manual chest wall vibration in addition to routine nursing care twice daily (morning and evening). Before the intervention, patients were informed and provided written consent. Baseline measurements included dyspnea (Modified Borg Scale), pain (VNRS), vital signs, and arterial blood gas values. The intervention was performed in semi-Fowler's position during the expiratory phase, applying gentle vibrations from lower to upper lobes for approximately 5 minutes (10 breathing cycles). Patients were guided to use slow nasal inhalation and pursed-lip exhalation. Outcomes were reassessed at 3rd, 5th, and 10th minutes after the intervention. The same procedure was repeated in the evening, and all data were recorded. |
Manual chest wall vibration is applied with the patient in a semi-Fowler's position during the expiratory phase of breathing. The practitioner places both hands flat on the chest wall and delivers gentle, rhythmic vibrations, starting from the lower lobes and progressing toward the upper lobes. Patients are instructed to inhale slowly through the nose and exhale using a pursed-lip breathing technique with a 1:2 inspiration-expiration ratio. The procedure is performed for approximately 5 minutes, corresponding to about 10 respiratory cycles, and is typically applied during the patient's rest period following routine care. |
|
Sham Comparator: Conventional Control Group
Control group patients were informed about the study and provided written consent. They received only routine nursing care without any additional intervention. At baseline (0 min), Patient Identification and Follow-up Forms were completed. Dyspnea was assessed using the Modified Borg Scale (MBS), pain using the Visual Numeric Rating Scale (VNRS), and vital signs and arterial blood gas values were recorded. Following routine care, measurements of vital signs, blood gases, dyspnea, and pain were repeated at 0, 3, 5, and 10 minutes and documented. Unlike the intervention group, no manual chest wall vibration was applied, and standard clinical follow-up was maintained. The same monitoring and recording procedures were repeated in the evening session. |
Control group patients were informed about the study and provided written consent. They received only routine nursing care, with no additional interventions applied. Baseline measurements were taken at 0 minutes, including dyspnea (MBS), pain (VNRS), vital signs, and arterial blood gas values. Following routine care, the same parameters were reassessed at 3, 5, and 10 minutes and recorded. No manual chest wall vibration was performed; only standard clinical monitoring was maintained. The same assessment protocol was repeated in the evening session. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Follow-Up Form
Time Frame: 1 day
|
Changes in respiratory and hemodynamic parameters (including respiratory rate, peripheral oxygen saturation, heart rate, blood pressure), dyspnea severity (Modified Borg Scale), and pain intensity (Visual Numeric Rating Scale) measured before the intervention and at 0, 1, 5, 10, and 15 minutes after the intervention.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-Operative Respiratory Status Questionnaire
Time Frame: 1 day
|
A 6-item patient-reported questionnaire using a 5-point Likert scale will be used to assess postoperative respiratory symptoms and adherence to breathing exercises.
Higher scores indicate better outcomes.
|
1 day
|
|
Questionnaire on manual chest wall vibration therapy
Time Frame: 1 day
|
A 9-item Likert-type questionnaire will be used to assess patient comfort, perceived benefit, and satisfaction with manual chest wall vibration.
Higher scores indicate more favorable outcomes.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sibel YILMAZ SAHİN, Assoc Prof, Institute of Health Sciences, Saglik Bilimleri University
- Principal Investigator: Beyza SU, MSc., Institute of Health Sciences, Saglik Bilimleri University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBU-SBF-BS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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