COPDNCT07361978
The Effect of Pursed-Lip Breathing Exercise on Anxiety and Physiological Parameters Post-Bronchoscopy in Patients With COPD: A Randomized Controlled Trial
A study testing Pursed-Lip Breathing exercise and Routine Care in people with COPD, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial investigates the effect of Pursed Lip Breathing (PLB) on anxiety levels and physiological parameters in patients with Chronic Obstructive Pulmonary Disease (COPD) following bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Pursed-Lip Breathing exercise and Routine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jan 2026to 21 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Süreyyapaşa Göğüs Hastalıkları ve Göğüs Cerrahisi EAH
Istanbul, Maltepe, 34840
About this study
Official title: The Effect of Purse-Lip Breathing Exercise on Anxiety and Physiological Parameters Post-Bronchoscopy in Patients With COPD: A Randomized Controlled Trial
This randomized controlled trial investigates the effect of Pursed Lip Breathing (PLB) on anxiety levels and physiological parameters in patients with Chronic Obstructive Pulmonary Disease (COPD) following bronchoscopy. While PLB is known to improve oxygenation and ventilation in pulmonary rehabilitation, its specific impact on the immediate recovery period after bronchoscopy is understudied. The study aims to determine if nurse-led PLB intervention significantly improves heart rate, blood pressure, oxygen saturation, and reduces anxiety compared to standard care.
Read the 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.
- Conditions
- COPD
- Being tested
- Pursed-Lip Breathing exercise and Routine Care
- Keywords
- copd, pursed-lip breathing, Nursing care, anxiety
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pursed-Lip Breathing exercise and Routine CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | There will be normal nursing care |
| PLB + Routine Care | Experimental | 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. Receives: Other: Pursed-Lip Breathing exercise and Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Level
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.
Measured: Baseline (Pre-procedure) and immediately after the bronchoscopy procedure (up to 30 minutes).
Secondary outcomes (4)
Change in Oxygen Saturation (SpO2)
Measured via pulse oximetry. Values are recorded as a percentage (%). Higher values indicate better physiological oxygenation status. Unit of measure: Percentage of oxygen saturation
Measured: 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
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.
Measured: Baseline, during the procedure, and immediately after the procedure (up to 30 minutes).
Change in Systolic Blood Pressure
Measured via non-invasive blood pressure cuff. Values are recorded in millimeters of mercury (mmHg).
Measured: Baseline (pre-procedure), during the procedure, and immediately after the procedure (up to 30 minutes).
Change in Diastolic Blood Pressure
Measured via non-invasive blood pressure cuff. Values are recorded in millimeters of mercury (mmHg).
Measured: Baseline (pre-procedure), during the procedure, and immediately after the procedure (up to 30 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start28 Jan 2026 (estimated)
- Primary completion28 Sep 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruhat Tilki, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361978
- Sponsor's protocol ID
- 133.2025fbu
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Purse-Lip Breathing Exercise on Anxiety and Physiological Parameters Post-Bronchoscopy in Patients With COPD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07361978
- Acronym / sponsor ID
- 133.2025fbu
- Conditions
- COPD
- Keywords
- copd, pursed-lip breathing, Nursing care, anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial investigates the effect of Pursed Lip Breathing (PLB) on anxiety levels and physiological parameters in patients with Chronic Obstructive Pulmonary Disease (COPD) following bronchoscopy. While PLB is known to improve oxygenation and ventilation in pulmonary rehabilitation, its specific impact on the immediate recovery period after bronchoscopy is understudied. The study aims to determine if nurse-led PLB intervention significantly improves heart rate, blood pressure, oxygen saturation, and reduces anxiety compared to standard care.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | –There will be normal nursing care |
| PLB + Routine Care | Experimental | Other: Pursed-Lip Breathing exercise and Routine CareFollowing 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pursed-Lip Breathing exercise and Routine CarePursed-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. | Other | PLB + Routine Care |
Primary outcome
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.
4 secondary outcomes
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.)
Change in Heart Rate
Time frame: 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).
Change in Diastolic Blood Pressure
Time frame: Baseline (pre-procedure), during the procedure, and immediately after the procedure (up to 30 minutes).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pursed-Lip Breathing exercise and Routine Care in people with COPD, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruhat Tilki, PhD Candidate (+90 553 514 98 10, ruhat.tilki@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety Level (time frame: Baseline (Pre-procedure) and immediately after the bronchoscopy procedure (up to 30 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.