Evaluating the impact of the ‘Blow, Breathe, Cough’ health promotion intervention in resolving otitis media with effusion in children: An adaptive randomized-controlled trial protocol

Evaluating the impact of the ‘Blow, Breathe, Cough’ health promotion intervention in resolving otitis media with effusion in children: An adaptive randomized-controlled trial protocol

Introduction: Otitis media with effusion (OME) affects hearing, speech development, and quality of life (QoL) in children. The ‘Blow, Breathe, Cough’ (BBC) intervention promotes nasal, respiratory, and middle ear clearance through nose blowing, deep breathing, coughing, and hand hygiene. It shows pr...

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Main Authors: Jaimee R. Rich, Michael Dymock, Elke J. Seppanen, Elena Montgomery, Tanisha Cayley, Tamara Veselinović, Greta Bernabei, Anri Lester, Amy Hannigan, Nicole Irvine, Kerryn Gidgup, Edna Ninyette, Steph Bray, Tu Trang Tran, Valerie M. Swift, Melinda Edmunds, Natalie Strobel, Daniel McAullay, Julie Marsh, Evelyn Tay, Lea-Ann S. Kirkham, Ruth B. Thornton, Robyn S.M. Choi, Lydia Timms, Emily Jackson, Jafri Kuthubutheen, Peter C. Richmond, Christopher G. Brennan-Jones
Format: Article
Language:English
Published: Elsevier 2025-10-01
Series:Contemporary Clinical Trials Communications
Subjects:
Pediatric otolaryngology
Middle ear effusion
Health promotion
Clinical trial protocol
Bayesian models
Online Access:http://www.sciencedirect.com/science/article/pii/S245186542500105X
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Summary:Introduction: Otitis media with effusion (OME) affects hearing, speech development, and quality of life (QoL) in children. The ‘Blow, Breathe, Cough’ (BBC) intervention promotes nasal, respiratory, and middle ear clearance through nose blowing, deep breathing, coughing, and hand hygiene. It shows promise in resolving OME but lacks randomized-controlled trial (RCT) evaluation. This paper presents a RCT protocol evaluating BBC's effect on OME resolution, hearing, speech, and QoL in children aged two to seven years. Methods: This parallel-group, 1:1, outcome assessor-blinded, individual adaptive RCT investigates whether completing the BBC intervention plus hand hygiene twice-daily at home increases OME resolution after 4-to-6 weeks in children with OME, compared to hand hygiene alone. Families (n = 250) perform their individually randomized program (BBC plus hand hygiene, or hand hygiene only) at home. The primary outcome is the difference in OME resolution rates between trial arms, assessed using tympanometry (type B to A or C1 transition) and otoscopy. Secondary outcomes include natural OME resolution, discharges from tertiary care, family satisfaction, hearing thresholds, QoL, bacterial load in the nasopharynx and on hands, cost comparison within the RCT versus standard care, and adverse events. All outcomes are measured by blinded researchers. An intention-to-treat analysis will be performed on all randomized participants. Guided by an Aboriginal Community Advisory Group, the RCT ensures culturally appropriate research whilst addressing community priorities in managing childhood ear disease. Discussion: If efficacious, BBC could reform OME treatment, reduce costs, and improve long-term hearing, speech, and QoL outcomes in some children. Its accessibility offers a globally scalable solution.
ISSN:2451-8654

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