- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07361978
The Effect of Pursed-Lip Breathing Exercise on Anxiety and Physiological Parameters Post-Bronchoscopy in Patients With COPD: A Randomized Controlled Trial
The Effect of Purse-Lip Breathing Exercise on Anxiety and Physiological Parameters Post-Bronchoscopy in Patients With COPD: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD), which ranks among the leading causes of morbidity and mortality worldwide, is expected to have increasingly negative consequences. There are over 600 million COPD patients worldwide and approximately 2-3 million in Turkey. COPD requires a complex and long-term response that coordinates the contributions of a wide range of professionals, specific types of medication, and appropriate monitoring equipment, and this care should ideally be integrated into a system that promotes patient empowerment. The associated treatment process involves repeated hospital admissions, which impose high economic costs on countries.
In the dynamic environment of critical care medicine, bedside bronchoscopy has emerged as a crucial diagnostic and therapeutic tool that bridges the gap between traditional pulmonary interventions and the urgent needs of critically ill patients. Bronchoscopy allows direct visualization of the airways and lung parenchyma and can be useful in evaluating various bronchopulmonary conditions and diseases, including foreign bodies, tumors, infectious and inflammatory processes, airway obstruction, and bronchopulmonary hemorrhage. Bronchoscopy may also be associated with other complications and discomforts beyond existing respiratory system problems.
Teaching patients breathing exercises is another nursing intervention that can increase oxygenation and reduce dyspnea. Various breathing exercises are available, including PLB. PLB is a breathing technique used to improve oxygenation and ventilation. This breathing technique involves consciously inhaling through the nose, followed by a slow and controlled exhalation through pursed or pinched lips, which prolongs the exhalation phase compared to the normal inspiration-exhalation ratio.
Nurses' ability to promptly recognize distress enables intervention teams to respond quickly and prevent further deterioration. The literature shows that pursed-lip breathing improves vital signs and oxygenation in COPD rehabilitation and during the recovery process after bronchoscopy. In a recent study, patients who practiced pursed-lip breathing during the post-bronchoscopy period showed significant improvements in parameters such as oxygen saturation, pulse rate, and blood pressure compared to the control group. However, studies examining the effect of this technique on anxiety and immediate physiological parameters in COPD patients during the bronchoscopy procedure are limited. This study was designed as a randomized controlled trial to determine the effect of PLB application on anxiety levels and physiological parameters (heart rate, blood pressure, oxygen saturation) in patients with COPD after bronchoscopy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ruhat Tilki, PhD Candidate
- Phone Number: +90 553 514 98 10
- Email: ruhat.tilki@fbu.edu.tr
Study Locations
-
-
Maltepe
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Istanbul, Maltepe, Turkey (Türkiye), 34840
- Süreyyapaşa Göğüs Hastalıkları ve Göğüs Cerrahisi EAH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed with COPD
- Patients undergoing elective bronchoscopy under sedation
- Patients aged 18 - 80 years
- Patients who are fully oriented, conscious, and able to communicate
Exclusion Criteria:
- Patients undergoing emergency bronchoscopy
- Patients with hemodynamic instability prior to the procedure (systolic blood pressure <90 mmHg or >180 mmHg)
- Patients with severe hearing or cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Routine Care
There will be normal nursing care
|
|
|
Experimental: PLB + Routine Care
Following a conscious inhalation through the nose, it involves exhaling slowly and in a controlled manner through pursed lips; this prolongs the exhalation phase compared to the normal inspiration-exhalation ratio.
|
Pursed-Lip Breathing exercise will be done.
Following a conscious inhalation through the nose, it involves exhaling slowly and in a controlled manner through pursed lips; this prolongs the exhalation phase compared to the normal inspiration-exhalation ratio.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in State Anxiety Level
Time Frame: Baseline (Pre-procedure) and immediately after the bronchoscopy procedure (up to 30 minutes).
|
Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI), specifically the State Anxiety subscale (STAI-S).
The scale consists of 20 items.
Total scores range from a minimum of 20 to a maximum of 80. Higher scores indicate higher levels of anxiety (worse outcome), while lower scores indicate lower levels of anxiety.
|
Baseline (Pre-procedure) and immediately after the bronchoscopy procedure (up to 30 minutes).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Oxygen Saturation (SpO2)
Time Frame: Baseline, during the procedure, and immediately after the procedure. Baseline, during the procedure, and immediately after the procedure. (30 minutes before and after the procedure.)
|
Measured via pulse oximetry.
Values are recorded as a percentage (%).
Higher values indicate better physiological oxygenation status.
Unit of measure: Percentage of oxygen saturation
|
Baseline, during the procedure, and immediately after the procedure. Baseline, during the procedure, and immediately after the procedure. (30 minutes before and after the procedure.)
|
|
Change in Heart Rate
Time Frame: Baseline, during the procedure, and immediately after the procedure (up to 30 minutes).
|
Measured via pulse oximetry or cardiac monitor.
Values are recorded as beats per minute (bpm).
Lower values (within normal range) generally indicate lower physiological stress.
|
Baseline, during the procedure, and immediately after the procedure (up to 30 minutes).
|
|
Change in Systolic Blood Pressure
Time Frame: Baseline (pre-procedure), during the procedure, and immediately after the procedure (up to 30 minutes).
|
Measured via non-invasive blood pressure cuff.
Values are recorded in millimeters of mercury (mmHg).
|
Baseline (pre-procedure), during the procedure, and immediately after the procedure (up to 30 minutes).
|
|
Change in Diastolic Blood Pressure
Time Frame: Baseline (pre-procedure), during the procedure, and immediately after the procedure (up to 30 minutes).
|
Measured via non-invasive blood pressure cuff.
Values are recorded in millimeters of mercury (mmHg).
|
Baseline (pre-procedure), during the procedure, and immediately after the procedure (up to 30 minutes).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
- 133.2025fbu
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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