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 ("SEES")

January 13, 2025 updated by: Suwimon Rojnawee, PhD, RN, Chulalongkorn University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Faculty of Nursing, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Balloon-blowing exercises

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.
Behavioral: Balloon-Blowing exercise program

he 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
  2. Setting Goals and Planning Self-Care
  3. Self-Care Implementation: 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
Experimental: Standard nursing care
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.
Behavioral: Standard nursing care
The actions of nurses towards school-age children with obstructive sleep apnea at the hospital 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Muscle strength
Time Frame: 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
Change from Baseline Respiratory Muscle strength at 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of sleep apnea
Time Frame: Change from Baseline severity of sleep apnea at 5 weeks

The severity of sleep apnea is assessed using the Sleep-Related Breathing Disorder Pediatric Sleep Questionnaire (SRBD-PSQ), which evaluates the severity of obstructive sleep apnea (OSA). The questionnaire consists of 22 items addressing the frequency of snoring, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, hyperactivity or inattention, and symptoms of obstructive sleep apnea. Responses are scored as follows: "Yes" = 1 point, "No" = 0 points, and "Don't know" is considered missing.

The total score is calculated by summing the scores of all answered items and dividing by the number of items answered (excluding items marked as missing). The score ranges from 0 to 1, with higher scores indicating greater severity of OSA and lower scores indicating less severity.
Change from Baseline severity of sleep apnea at 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2024

Primary Completion (Actual)

March 16, 2024

Study Completion (Actual)

May 8, 2024

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 829/66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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