Pre- and post-operative voice therapy for benign vocal fold lesions: protocol for a non-randomised, multicentre feasibility trial with embedded process evaluation.
Benign vocal fold lesions
Feasibility
Phonosurgery
Pre- and post-operative
Process evaluation
Voice therapy
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
23 May 2024
23 May 2024
Historique:
received:
10
02
2023
accepted:
10
05
2024
medline:
24
5
2024
pubmed:
24
5
2024
entrez:
24
5
2024
Statut:
epublish
Résumé
Management of benign vocal fold lesions (BVFLs) is variable with individuals receiving surgery, voice therapy, or a combination of these approaches. Some evidence suggests that the best outcomes may be achieved when patients are offered pre- and post-operative voice therapy in addition to phonosurgery, but what constitutes pre- and post-operative voice therapy is poorly described. The pre- and post-operative voice therapy (PAPOV) intervention has been developed and described according to the TIDieR checklist and Rehabilitation Treatment Specification System (RTSS) for voice. The PAPOV intervention is delivered by specialist speech and language therapists trained in the intervention and comprises 7 essential and 4 additional components, delivered in voice therapy sessions with patients who are having surgery on their vocal folds for removal of BVFLs. Non-randomised, multicentre feasibility trial with embedded process evaluation. Forty patients from two sites who are due to undergo phonosurgery will be recruited to receive the PAPOV intervention. Measures of feasibility, including recruitment, retention, and adherence, will be assessed. The feasibility of gathering clinical and cost effectiveness data will be measured pre-treatment, then at 3 and 6 months post-operatively. An embedded process evaluation will be undertaken to explain feasibility findings. This study will assess the feasibility of delivering a described voice therapy intervention protocol to patients who are undergoing surgery for removal of BVFLs. Findings will be used to inform the development and implementation of a subsequent effectiveness trial, should this be feasible. This trial has been prospectively registered on ISRCTN (date 4th January 2023), registration number 17438192, and can be viewed here: https://www.isrctn.com/ISRCTN17438192 .
Sections du résumé
BACKGROUND
BACKGROUND
Management of benign vocal fold lesions (BVFLs) is variable with individuals receiving surgery, voice therapy, or a combination of these approaches. Some evidence suggests that the best outcomes may be achieved when patients are offered pre- and post-operative voice therapy in addition to phonosurgery, but what constitutes pre- and post-operative voice therapy is poorly described. The pre- and post-operative voice therapy (PAPOV) intervention has been developed and described according to the TIDieR checklist and Rehabilitation Treatment Specification System (RTSS) for voice. The PAPOV intervention is delivered by specialist speech and language therapists trained in the intervention and comprises 7 essential and 4 additional components, delivered in voice therapy sessions with patients who are having surgery on their vocal folds for removal of BVFLs.
STUDY DESIGN
METHODS
Non-randomised, multicentre feasibility trial with embedded process evaluation.
METHOD
METHODS
Forty patients from two sites who are due to undergo phonosurgery will be recruited to receive the PAPOV intervention. Measures of feasibility, including recruitment, retention, and adherence, will be assessed. The feasibility of gathering clinical and cost effectiveness data will be measured pre-treatment, then at 3 and 6 months post-operatively. An embedded process evaluation will be undertaken to explain feasibility findings.
DISCUSSION
CONCLUSIONS
This study will assess the feasibility of delivering a described voice therapy intervention protocol to patients who are undergoing surgery for removal of BVFLs. Findings will be used to inform the development and implementation of a subsequent effectiveness trial, should this be feasible.
TRIAL REGISTRATION
BACKGROUND
This trial has been prospectively registered on ISRCTN (date 4th January 2023), registration number 17438192, and can be viewed here: https://www.isrctn.com/ISRCTN17438192 .
Identifiants
pubmed: 38783383
doi: 10.1186/s40814-024-01508-1
pii: 10.1186/s40814-024-01508-1
doi:
Types de publication
Journal Article
Langues
eng
Pagination
84Subventions
Organisme : National Institute for Health and Care Research
ID : NIHR301570
Informations de copyright
© 2024. The Author(s).
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