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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

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.

Citation:
Rich JR, Dymock M, Seppanen EJ, Montgomery E, Cayley T, Veselinović T, Bernabei G, Lester A, Hannigan A, Irvine N, Gidgup K, Ninyette E, Bray S, Tran TT, Swift V, Edmunds M,  Srobel N, MAullay D, Marsh J, Tay E, Kirkham LAS, Thornton RB, Choi RSM, Timms L, Jackson E, Kuthubutheen J, Richmond PC, Brennan-Jones CG. 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. Contemp Clin Trials Comm. 2025;47.

Keywords:
Bayesian models; Clinical trial protocol; Health promotion; Middle ear effusion; Pediatric otolaryngology

Abstract:
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.