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

NCT ID: NCT07106203

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-05-01

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.

Detailed Description

Pneumonia remains one of the leading causes of hospitalization and morbidity in early childhood, often requiring supportive respiratory interventions. Pursed-Lip Breathing (PLB) is a simple, non-pharmacological respiratory technique that has shown promise in improving respiratory function by increasing exhalation time, enhancing oxygenation, and reducing respiratory workload.

This randomized controlled trial aims to evaluate the effects of PLB exercises on physiological parameters (respiratory rate, heart rate, and oxygen saturation) and readiness for hospital discharge in children aged 3-4 years diagnosed with community-acquired pneumonia. Participants will be randomized into intervention and control groups. The intervention group will receive PLB exercises using a toy-based blowing device (saxophone ball blower) twice daily for three consecutive days under supervision, while the control group will receive standard care.

Physiological parameters will be measured immediately before and after each PLB session using standardized methods. In addition, parental perception of discharge readiness will be assessed using the Pediatric Readiness for Hospital Discharge Scale - Parent Form (Ped-RHDS) on the first and third days of hospitalization.

The study hypothesizes that PLB exercises will lead to improved oxygen saturation, reduced respiratory and heart rates, and increased readiness for discharge in the intervention group compared to controls. This research will contribute to the evidence supporting non-pharmacological nursing interventions that can enhance respiratory outcomes and discharge processes in pediatric pneumonia patients.

Conditions

Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

PLB Intervention Group

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.

Group Type: EXPERIMENTAL

Pursed-Lip Breathing (PLB)

Intervention Type: 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.

Interventions

Pursed-Lip Breathing (PLB)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Türkan Kadiroğlu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Türkan KADIROĞLU, Asst Prof

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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

Erzurum, Erzurum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Türkan KADİROĞLU, Asst Prof

Role: CONTACT

t.kadiroglu@atauni.edu.tr

+90 442 231 5799 ext. +905309223025

Emrah DURSUN, Res Asst

Role: CONTACT

e.dursun@beu.edu.tr

+90 (434) 222 8360 ext. +905318226552

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

B.30.2.ATA.0.01.00/647

Identifier Type: OTHER

Identifier Source: secondary_id

ATU-PLB-2025

Identifier Type: -

Identifier Source: org_study_id