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

NCT ID: NCT06780982

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-12

Study Completion Date

2024-05-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea of Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The experimental group received the self-care emphasizing on balloon-blowing exercises program for five weeks based on Orem's self-care theory (2001), while the control group received regular nursing care.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Balloon-Blowing exercise program

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Standard nursing care

Intervention Type BEHAVIORAL

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.

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Suwimon Rojnawee, PhD, RN

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Nursing, Chulalongkorn University

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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Camacho M, Certal V, Abdullatif J, Zaghi S, Ruoff CM, Capasso R, Kushida CA. Myofunctional Therapy to Treat Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. Sleep. 2015 May 1;38(5):669-75. doi: 10.5665/sleep.4652.

Reference Type RESULT
PMID: 25348130 (View on PubMed)

Koka V, De Vito A, Roisman G, Petitjean M, Filograna Pignatelli GR, Padovani D, Randerath W. Orofacial Myofunctional Therapy in Obstructive Sleep Apnea Syndrome: A Pathophysiological Perspective. Medicina (Kaunas). 2021 Apr 1;57(4):323. doi: 10.3390/medicina57040323.

Reference Type RESULT
PMID: 33915707 (View on PubMed)

Schivinski CIS, Manna BC, Belem FJDM, Castilho T. THERAPEUTIC BLOWING TOYS: DOES THE OVERLAP OF VENTILATORY STIMULI ALTER THE RESPIRATORY MECHANICS OF HEALTHY SCHOOLCHILDREN? Rev Paul Pediatr. 2020 Mar 9;38:e2018259. doi: 10.1590/1984-0462/2020/38/2018259. eCollection 2020.

Reference Type RESULT
PMID: 32159645 (View on PubMed)

Zecha-Stallinger A, Wenzel V, Wagner-Berger HG, von Goedecke A, Lindner KH, Hormann C. A strategy to optimise the performance of the mouth-to-bag resuscitator using small tidal volumes: effects on lung and gastric ventilation in a bench model of an unprotected airway. Resuscitation. 2004 Apr;61(1):69-74. doi: 10.1016/j.resuscitation.2003.12.012.

Reference Type RESULT
PMID: 15081184 (View on PubMed)

Misra A, Pawar R, Pal A. Effect of Balloon-Blowing Exercise on Oxygen Saturation in COVID-19 Patients. Cureus. 2023 Jun 11;15(6):e40250. doi: 10.7759/cureus.40250. eCollection 2023 Jun.

Reference Type RESULT
PMID: 37440814 (View on PubMed)

Marcus CL, Loughlin GM. Obstructive sleep apnea in children. Semin Pediatr Neurol. 1996 Mar;3(1):23-8. doi: 10.1016/s1071-9091(96)80025-8.

Reference Type RESULT
PMID: 8795838 (View on PubMed)

Potsic WP. Sleep apnea in children. Otolaryngol Clin North Am. 1989 Jun;22(3):537-44.

Reference Type RESULT
PMID: 2657582 (View on PubMed)

Ishman SL, Li C, Dhanda Patil R. Sleep Renewed: Innovations in Sleep Apnea Care for Adults and Children. Otolaryngol Clin North Am. 2024 Jun;57(3):xv-xvi. doi: 10.1016/j.otc.2024.02.018. Epub 2024 Mar 8. No abstract available.

Reference Type RESULT
PMID: 38458954 (View on PubMed)

Redline S, Cook K, Chervin RD, Ishman S, Baldassari CM, Mitchell RB, Tapia IE, Amin R, Hassan F, Ibrahim S, Ross K, Elden LM, Kirkham EM, Zopf D, Shah J, Otteson T, Naqvi K, Owens J, Young L, Furth S, Connolly H, Clark CAC, Bakker JP, Garetz S, Radcliffe J, Taylor HG, Rosen CL, Wang R; Pediatric Adenotonsillectomy Trial for Snoring (PATS) Study Team. Adenotonsillectomy for Snoring and Mild Sleep Apnea in Children: A Randomized Clinical Trial. JAMA. 2023 Dec 5;330(21):2084-2095. doi: 10.1001/jama.2023.22114.

Reference Type RESULT
PMID: 38051326 (View on PubMed)

Erturk N, Calik-Kutukcu E, Arikan H, Savci S, Inal-Ince D, Caliskan H, Saglam M, Vardar-Yagli N, Firat H, Celik A, Yuce-Ege M, Ardic S. The effectiveness of oropharyngeal exercises compared to inspiratory muscle training in obstructive sleep apnea: A randomized controlled trial. Heart Lung. 2020 Nov-Dec;49(6):940-948. doi: 10.1016/j.hrtlng.2020.07.014. Epub 2020 Aug 13.

Reference Type RESULT
PMID: 32800391 (View on PubMed)

Other Identifiers

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829/66

Identifier Type: -

Identifier Source: org_study_id

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