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NCT Number: NCT07106203

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

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.

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Key information

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Erzurum, 25070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Change in Respiratory Rate

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

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

  2. Change in Heart Rate

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

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

  3. Change in Oxygen Saturation (SpO₂)

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

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

Secondary outcomes

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emrah DURSUN, Res Asst

CONTACT

[email protected]

+90 (434) 222 8360 ext. +905318226552

Türkan KADİROĞLU, Asst Prof

CONTACT

[email protected]

+90 442 231 5799 ext. +905309223025

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Effect of Pursed-Lip Breathing on Physiological Parameters and Discharge Readiness in Children Diagnosed With Pneumonia: A Randomized Controlled Study

Acronym: PLB-PEDPNEU

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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