Effect of Pursed-Lip Breathing on Physiological Parameters and Discharge Readiness in Children With Pneumonia

NCT07106203 | Not Yet Recruiting

• 2 other identifiers: ATU-PLB-2025B.30.2.ATA.0.01.00/647
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of Pursed-Lip Breathing (PLB) exercises on physiological parameters (such as respiratory rate, heart rate, and oxygen saturation) and discharge readiness in children diagnosed with pneumonia. The study is designed as a randomized controlled trial involving pediatric patients between the ages of 3 and 4. The intervention includes guided PLB exercises performed twice daily for three consecutive days. Data will be collected before and after each session to assess changes in physiological measures and readiness for hospital discharge.

Conditions

Pneumonia

Keywords

Pursed-Lip Breathing; Pediatric Pneumonia; Respiratory Function; Discharge Readiness; Physiological Parameters; Pulmonary Rehabilitation; Non-pharmacological intervention

Outcome Measures

Primary Outcomes (3)

• Change in Respiratory Rate

  Respiratory rate will be measured before and after each PLB session to evaluate the intervention's effect on pulmonary function.

  Before and after each PLB session over a 3-day intervention period

• Change in Heart Rate

  Heart rate will be recorded before and after each PLB session to assess changes in cardiovascular response.

  Before and after each PLB session over a 3-day intervention period

• Change in Oxygen Saturation (SpO₂)

  Peripheral oxygen saturation (SpO₂) will be evaluated before and after each PLB session to determine its impact on oxygenation.

  Before and after each PLB session over a 3-day intervention period

Secondary Outcomes (1)

• Change in Pediatric Readiness for Hospital Discharge Scale - Parent Form (Ped-RHDS) Scores

  Day 1 (morning) and Day 3 (evening)

Study Arms (2)

Control Group

NO INTERVENTION

Children aged 3-4 years diagnosed with pneumonia will receive only standard hospital care. No additional respiratory exercise will be applied. Physiological parameters will be measured at the same intervals as the intervention group for comparison.

PLB Intervention Group

EXPERIMENTAL

Children aged 3-4 years diagnosed with pneumonia will receive Pursed-Lip Breathing (PLB) exercises under nurse supervision, twice daily for three consecutive days. PLB will be performed using playful methods with a toy (e.g., saxophone ball). Respiratory rate, heart rate, and oxygen saturation will be measured before and after each session.

Behavioral: Pursed-Lip Breathing (PLB)

Interventions

Pursed-Lip Breathing (PLB) BEHAVIORAL

Children in the intervention group will receive Pursed-Lip Breathing exercises twice daily for three days under nurse supervision. Exercises will be applied using playful techniques with a toy (e.g., saxophone ball). Physiological parameters will be measured before and after each session.

PLB Intervention Group

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3 to 4 years
• Diagnosed with community-acquired pneumonia (CAP), defined as pneumonia occurring in a previously healthy child within 14 days of symptom onset and requiring hospitalization
• The child's primary caregiver is the mother
• Both mother and child must remain in the hospital for at least 3 days
• Hospitalization due to pneumonia with an expected average stay of 4-5 days, based on disease severity and clinical condition
• Mother must be present as a caregiver throughout the hospital stay
• Voluntary participation with signed informed consent from the parent or legal guardian

You may not qualify if:

• Presence of any chronic disease in addition to pneumonia
• Mother not staying as a caregiver during hospitalization
• Withdrawal of consent by the mother and/or child
• Discharge before 3 days for any reason (e.g., refusal of treatment, early discharge request)

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University Health Sciences Institute and Research Hospital - Department of Pediatrics

Erzurum, Erzurum, 25070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumonia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Türkan KADIROĞLU, Asst Prof

  Ataturk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Türkan KADİROĞLU, Asst Prof

CONTACT

+90 442 231 5799; t.kadiroglu@atauni.edu.tr

Emrah DURSUN, Res Asst

CONTACT

+90 (434) 222 8360; e.dursun@beu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to participant group assignments to minimize detection bias. Data analysis will also be conducted by an independent researcher who is unaware of group allocations. Due to the nature of the intervention, participants and intervention providers cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This randomized controlled study includes two arms: an intervention group receiving Pursed-Lip Breathing (PLB) exercises twice daily and a control group receiving standard care. The intervention will be performed over a 3-day period.

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 6, 2025
• Study Start: November 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication and ending 2 years later.
• Access Criteria: With researchers who submit a methodologically sound proposal and receive approval from the study team.

Locations

TU (1)