CClinicalTrials.gg
CompletedNCT07106203PLB-PEDPNEUUpdated Sep 28, 2026

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

An interventional study of Pursed-Lip Breathing (PLB) in Pneumonia, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 4 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Ataturk University · Not applicable, Interventional, and Treatment

Updated Sep 28, 2026Now CompletedStart date moved+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
3 Years to 4 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pneumonia

Keywords

  • Pursed-Lip Breathing
  • Pediatric Pneumonia
  • Respiratory Function
  • Discharge Readiness
  • Physiological Parameters
  • Pulmonary Rehabilitation
  • Non-pharmacological intervention
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 82 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 4 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • No intervention
    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.

  • Experimental
    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.

    Behavioral: Pursed-Lip Breathing (PLB)

Interventions

  • BehavioralPursed-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.

06

What researchers measure

Primary outcomes

  1. Change in Respiratory Rate

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

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

  2. Change in Heart Rate

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

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

  3. Change in Oxygen Saturation (SpO₂)

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

    Time frame: 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

    The Pediatric Readiness for Hospital Discharge Scale - Parent Form (Ped-RHDS) will be administered to parents by an independent nurse on Day 1 (morning) and Day 3 (evening) of hospitalization. The scale evaluates parents' perceptions of their child's readiness for discharge. The total score ranges from 0 to 100, with higher scores indicating a greater perceived readiness for hospital discharge. This outcome measure will be used to assess the effect of the PLB intervention on discharge preparedness.

    Time frame: Day 1 (morning) and Day 3 (evening)

07

Study locations

1 site
  • Atatürk University Health Sciences Institute and Research Hospital - Department of Pediatrics
    Erzurum, 25070, Turkey (Türkiye)
08

References and documents

Study documents

  • Statistical analysis plan · Jun 15, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Individual participant data (IPD) that underlie the results reported in this study (after de-identification) will be shared with qualified researchers. Data will be available for secondary analysis upon request, starting 6 months after publication and for a period of 2 years.

Supporting information: Study protocol, Sap, Icf

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Completed
changed Sep 28, 2026
Sites
1 site added, 1 site removed
Show site
  • Atatürk University Health Sciences Institute and Research Hospital - Department of Pediatrics · Erzurum, Turkey (Türkiye)
Show 1 removed
  • Atatürk University Health Sciences Institute and Research Hospital - Department of Pediatrics · Erzurum, Turkey (Türkiye)
Sep 28, 2026
Start date
Nov 1, 2025→Jul 1, 2025 (actual)
Sep 28, 2026
Primary completion
Feb 1, 2026→Mar 30, 2026 (actual)
Sep 28, 2026
Study completion
May 1, 2026→Jun 30, 2026 (actual)
Sep 28, 2026
Enrollment
66 (estimated)→82 (actual)
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Not yet recruiting→Completed
    1 site added, 1 site removed
    Show site
    • Atatürk University Health Sciences Institute and Research Hospital - Department of Pediatrics · Erzurum, Turkey (Türkiye)
    Show 1 removed
    • Atatürk University Health Sciences Institute and Research Hospital - Department of Pediatrics · Erzurum, Turkey (Türkiye)
    Start date Nov 1, 2025→Jul 1, 2025 (now actual)
    Primary completion Feb 1, 2026→Mar 30, 2026 (now actual)
    Study completion May 1, 2026→Jun 30, 2026 (now actual)
    Enrollment 66 (estimated)→82 (actual)
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07106203
Lead sponsor
Ataturk University
Responsible party
Türkan Kadiroğlu (Associate Professor, Ataturk University) — Principal investigator
First posted
Aug 6, 2025
Start date
Jul 1, 2025
Primary completion
Mar 30, 2026
Completion
Jun 30, 2026
Last update
Sep 28, 2026

Study contacts

Türkan KADIROĞLU, Asst Prof
principal investigator · Ataturk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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