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dc.contributor.advisorKenny, Ciarán
dc.contributor.authorGrehan, Kate
dc.date.accessioned2022-12-21T10:07:08Z
dc.date.available2022-12-21T10:07:08Z
dc.date.issued2022
dc.date.submitted2022
dc.identifier.citationKate Grehan, 'A pilot randomised trial on the effect of Gaviscon Advance on laryngopharyngeal reflux symptoms in adults referred to an outpatient Speech and Language Therapy service', [thesis], Trinity College Dublin. School of Linguistic Speech & Comm Sci. Discipline of Clin Speech & Language Studies, 2022, Trinity College Dublin thesesen
dc.identifier.urihttp://hdl.handle.net/2262/101902
dc.description.abstractBackground: Laryngopharyngeal reflux (LPR) can result in vocal tract symptoms and voice problems. The exact pathophysiology and prevalence of LPR is unknown. It can lead to a wide variety of symptoms, and as a result assessment and diagnosis can be challenging. There are a range of management options with a growing body of evidence to advocate for the use of sodium alginate in the treatment of LPR. Studies have examined the benefit of taking sodium alginate after a 2-to-6-month time period but none have examined the effect of taking sodium alginate over a shorter time period and whether this would still have a similar effect. Aims: This research aims to explore the feasibility of conducting a study to explore the impact of Gaviscon Advance on symptoms of LPR amongst adults being referred to an outpatient Speech and Language Therapy department by their Ear, Nose and Throat (ENT) surgeon. The objective is to guide and inform a larger scale experimental study. In particular, this research aims to explore the feasibility of a waitlist study design, recruitment of participants, adherence to the study protocol and to monitor for any unforeseen circumstances. Methods & Procedures: A pragmatic pilot trial was designed to explore the feasibility of a larger scale pragmatic randomised controlled trial (RCT). A pragmatic RCT was planned to be able to inform clinical practice. An RCT had not been conducted in this outpatient setting before and its practicality had to be established. Four participants were recruited by study gatekeepers while they were waiting their initial Speech and Language Therapy assessment and their participation ceased once they attended that assessment. Participants needed to score >13 in the Reflux Symptom Score (RSS) and meet the study eligibility criteria. Once recruited, participants were randomly assigned to the treatment group or the no-treatment control group. The treatment group was advised to take 10mls sodium alginate (Gaviscon Advance) after breakfast, lunch and dinner and again before bed. The no-treatment control group was advised not to change anything and that management would be discussed with them at their initial assessment. Both groups completed the RSS weekly to monitor for any changes in symptoms. A study diary was kept to record outcomes of study procedures and for any adverse events. Data were later extracted for analysis. Outcome & Results: A smaller scale pilot trial in preparation for a full pragmatic RCT was completed. Two participants were randomised to each group. The waitlist study design seemed to be appropriate to answer the research aims. Recruitment was best facilitated by choosing a single gatekeeper, since that person could assume responsibility for actively managing prospective participants. The eligibility criteria were deemed to be too stringent and excluded participants whose medical history would otherwise permit them to safely engage with the study protocol. One participant found it difficult to adhere to the Gaviscon Advance protocol due to the taste. Most participants completed the RSS and study documents accurately, but some had difficulty completing and returning them to the principal investigator. Conclusions: A full pragmatic randomised controlled trial is feasible, with some amendments to the original study protocol described.
dc.language.isoenen
dc.publisherTrinity College Dublin. School of Linguistic Speech & Comm Sci. Discipline of Clin Speech & Language Studiesen
dc.subjectlaryngopharyngeal reflux
dc.subjectvoice
dc.subjectdysphonia
dc.subjectsodium alginate
dc.subjectGaviscon Advance
dc.titleA pilot randomised trial on the effect of Gaviscon Advance on laryngopharyngeal reflux symptoms in adults referred to an outpatient Speech and Language Therapy serviceen
dc.typeThesisen
dc.type.supercollectionthesis_dissertations
dc.type.qualificationlevelMasters (Taught)
dc.type.qualificationnameMSc Clinical Speech & Language Studies
dc.rights.ecaccessrightsopenAccess
dc.relation.ispartofseriestitleTrinity College Dublin theses


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