NCT07361978

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

December 31, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

January 28, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

December 31, 2025

Last Update Submit

January 21, 2026

Conditions

COPD

Keywords

copdpursed-lip breathingNursing careanxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (Pre-procedure) and immediately after the bronchoscopy procedure (up to 30 minutes).

Secondary Outcomes (4)

  • Change in Oxygen Saturation (SpO2)

    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

    Baseline, during the procedure, and immediately after the procedure (up to 30 minutes).

  • Change in Systolic Blood Pressure

    Baseline (pre-procedure), during the procedure, and immediately after the procedure (up to 30 minutes).

  • Change in Diastolic Blood Pressure

    Baseline (pre-procedure), during the procedure, and immediately after the procedure (up to 30 minutes).

Study Arms (2)

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.

Other: Pursed-Lip Breathing exercise and Routine Care

Interventions

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.

PLB + Routine Care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Süreyyapaşa Göğüs Hastalıkları ve Göğüs Cerrahisi EAH

Istanbul, Maltepe, 34840, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAnxiety Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Ruhat Tilki, PhD Candidate

CONTACT

+90 553 514 98 10ruhat.tilki@fbu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 31, 2025

First Posted

January 23, 2026

Study Start

January 28, 2026

Primary Completion (Estimated)

September 28, 2026

Study Completion (Estimated)

December 21, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)