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临床试验/NCT06780982
NCT06780982已完成不适用

The Effect of Self-care Emphasizing on Balloon-Blowing Exercise Program on Severity of Sleep Apnea and Respiratory Muscle Strength Among School Age Children With Obstructive Sleep Apnea

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Respiratory Muscle strength

研究概览

简要总结

Obstructive sleep apnea (OSA) is a common condition in school-age children, often leading to sleep disturbances and associated health issues. Non-invasive interventions, such as respiratory muscle training, have shown promise in mitigating the severity of OSA. This study explores the effects of a self-care-focused balloon-blowing exercise program on improving respiratory muscle strength and reducing OSA severity in children.

This research aimed to study the effects of a self-care emphasizing on balloon-blowing exercises program on severity of sleep apnea and respiratory muscle strength in school-aged children diagnosed with mild to moderate obstructive sleep apnea (OSA), receiving treatment at the outpatient ENT department at Siriraj Hospital.

详细描述

Thirty children participated, divided into two groups: 15 children received the self-care emphasizing on balloon-blowing exercises program for five weeks based on Orem's self-care theory (2001), and 15 children received regular nursing care. The research instruments included a severity assessment scale for apnea and a self-care behavior assessment scale for children with OSA. Both instruments had content validity indexes of 0.95 and 0.80, and their reliability, Cronbach's alpha, were 0.83 and 0.76, respectively. Respiratory muscle strength was measured using a Respiratory Pressure Meter. Data were analyzed using statistical t-tests.

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
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •School-age children aged 6-12 years diagnosed with obstructive sleep apnea (OSA) of mild to moderate severity (AHI 1-9 events/hour).
  • •Children receiving a consistent medication dosage with no planned adjustments to increase the dosage.
  • •Fully conscious, with no hearing problems, and able to understand the Thai language.
  • •Children voluntarily agree to participate in the study, and their parents consent to provide care during the research period.
  • •Have a smartphone or tablet capable of using the LINE application, with the ability to operate the application under parental supervision.
  • •Agree to allow the researcher to communicate via LINE and phone calls.

排除标准

  • •Children with severe comorbidities or chronic illnesses requiring ongoing treatment.
  • •Children undergoing treatment with continuous positive airway pressure (CPAP) therapy.
  • •Children who have engaged in exercise sessions lasting more than 20 minutes per session, at least 3 times per week, within the 6 months prior to the start of data collection.

研究组 & 干预措施

Experimental: Balloon-blowing exercises

Experimental

The program begins with a one-on-one session on the first day of the research project and continues with home-based care through the LINE application on a smartphone for 5 weeks. The program consists of four steps:

  1. Decision-Making in Self-Care: Discussions to build rapport with the child, assess self-care deficits, and evaluate the child's current self-care behaviors based on their perceptions and experiences.
  2. Setting Goals and Planning Self-Care: Explanation self-care behaviors to the child and their parents and collaborate to create a care plan.
  3. Self-Care Implementation: The child and parents download educational materials via the LINE application and practicing the balloon-blowing exercise daily for 3 sets of 3 balloons per set (a total of 9 balloons/day), with a 1-minute rest between sets, over a period of 5 weeks.
  4. Maintaining Self-Care Behaviors: Encouragements for performing all five behaviors by having the child review materials via the LINE application once a week.

干预措施: Balloon-Blowing exercise program (Behavioral)

Standard nursing care

Experimental

The control group received standard nursing care, which involve screening patient records and distributing educational materials in the form of brochures to individual pediatric patients and their parents. The knowledge provided in the brochures includes instructions on how to administer inhaled medication, avoiding allergens, performing facial and neck muscle exercises, and attending follow-up appointments as scheduled.

干预措施: Standard nursing care (Behavioral)

结局指标

主要结局

Respiratory Muscle strength

时间窗: Change from Baseline Respiratory Muscle strength at 5 weeks

espiratory muscle strength is assessed using a Respiratory Pressure Meter (MicroRPM®) by Micromedical, a brand from the United Kingdom. This device evaluates respiratory muscle strength by measuring the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), with results recorded in cmH₂O. The maximal inspiratory pressure represents the strength of the inspiratory muscles, while the maximal expiratory pressure reflects the strength of the expiratory muscles. Measurements are obtained by having the participant exert maximal and rapid respiratory effort through the Respiratory Pressure Meter, sustaining the pressure for 2 seconds. Each measurement is repeated three times, and the average of the three readings is recorded in cmH₂O. Higher scores indicate greater respiratory muscle strength, while lower scores signify reduced strength. The recorded data is documented in the Maximal Inspiratory and Expiratory Pressure Recording Form (Appendix D). All assessments are con

次要结局

  • Severity of sleep apnea(Change from Baseline severity of sleep apnea at 5 weeks)

研究者

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

Suwimon Rojnawee, PhD, RN

Principal investigator

Chulalongkorn University

研究点 (1)

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