PneumoniaPLB-PEDPNEUNCT07106203
Effect of Pursed-Lip Breathing on Physiological Parameters and Discharge Readiness in Children With Pneumonia
A study testing Pursed-Lip Breathing (PLB) in people with Pneumonia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 4 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Pursed-Lip Breathing (PLB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Health Sciences Institute and Research Hospital - Department of Pediatrics
Erzurum, 25070
About this study
Official title: The Effect of Pursed-Lip Breathing on Physiological Parameters and Discharge Readiness in Children Diagnosed With Pneumonia: A Randomized Controlled Study
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.
- Conditions
- Pneumonia
- Being tested
- Pursed-Lip Breathing (PLB)
- Keywords
- Pursed-Lip Breathing, Pediatric Pneumonia, Respiratory Function, Discharge Readiness, Physiological Parameters, Pulmonary Rehabilitation, Non-pharmacological intervention
- Medical subject headings
- Pneumonia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pursed-Lip Breathing (PLB)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pursed-Lip Breathing (PLB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Respiratory Rate
Respiratory rate will be measured before and after each PLB session to evaluate the intervention's effect on pulmonary function.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 (morning) and Day 3 (evening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Jul 2025
- Primary completion30 Mar 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Türkan Kadiroğlu, Ataturk University
- Investigators
- Türkan KADIROĞLU, Asst Prof, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106203
- Sponsor's protocol ID
- ATU-PLB-2025
- Other IDs
- B.30.2.ATA.0.01.00/647
- Acronym
- PLB-PEDPNEU
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pursed-Lip Breathing on Physiological Parameters and Discharge Readiness in Children Diagnosed With Pneumonia: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07106203
- Acronym / sponsor ID
- PLB-PEDPNEU / ATU-PLB-2025
- Conditions
- Pneumonia
- Keywords
- Pursed-Lip Breathing, Pediatric Pneumonia, Respiratory Function, Discharge Readiness, Physiological Parameters, Pulmonary Rehabilitation, Non-pharmacological intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Pursed-Lip Breathing (PLB)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. |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | PLB Intervention Group |
Primary outcome
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.
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.
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.
1 secondary outcome
Change in Pediatric Readiness for Hospital Discharge Scale - Parent Form (Ped-RHDS) Scores
Time frame: Day 1 (morning) and Day 3 (evening)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Türkan KADIROĞLU, Asst Prof principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pursed-Lip Breathing (PLB) in people with Pneumonia, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Respiratory Rate (time frame: Before and after each PLB session over a 3-day intervention period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.