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临床试验/NCT07106203
NCT07106203尚未招募不适用

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

Ataturk University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
试验地点
1
主要终点
Change in Respiratory Rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
3 Years 至 4 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: Pursed-Lip Breathing (PLB) (Behavioral)

结局指标

主要结局

Change in Respiratory Rate

时间窗: 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

时间窗: 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)

时间窗: 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.

次要结局

  • Change in Pediatric Readiness for Hospital Discharge Scale - Parent Form (Ped-RHDS) Scores(Day 1 (morning) and Day 3 (evening))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Türkan Kadiroğlu

Associate Professor

Ataturk University

研究点 (1)

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