Pre and post-operative voice therapy for patients with benign vocal fold lesions Ear, Nose and Throat
Conditions
Interventions
Participants will receive a voice therapy package, termed the Pre- and Post-Operative Voice Therapy intervention (PAPOV). PAPOV includes a mix of information, education, advice and voice exercises. Th
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients with benign vocal fold lesions (BVFLs) who have been consented for phonosurgery by an ENT surgeon as part of their management 2. Aged 18 years old and over 3. Willing and able to offer informed consent 4. Presence of unilateral or bilateral benign vocal fold lesion on the vibrating portion of the vocal fold (including one or a combination of these diagnostic categories; fibrotic vocal fold nodules, polyp, cyst, pseudocyst, polypoid fringe, Reinke's odema, sulcus, mucosal bridge, papilloma); 5. Diagnosis confirmed using videolaryngostroboscopy 6. +/- presence of additional muscle tension dysphonia/inflammation
Exclusion criteria
Exclusion criteria: 1. Diagnosis of soft vocal fold nodules; these patients receive a different pathway of care 2. Diagnosis of arytenoid granuloma; this does not affect the vibratory portion of the vocal fold 3. Previous phonosurgery 4. Suspicion of malignancy requiring urgent microlaryngoscopy and biopsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility trial objectives are to gather data regarding the following parameters: 1. Number of eligible patients measured using the eligibility log and surgical lists at each site at the end of the study 2. Number of patients recruited and consented to the trial as a proportion of those eligible, measured using the eligibility log at each site at the end of the study 3. Number of patients completing the study as a proportion of those recruited measured using the case report form at the end of the study 4. The amount of clinical outcomes data completed measured using the case report form at each time point (baseline, 3 and 6 months post-surgery) (%) 5. The amount of health economics data completed measured using the case report form at each time point (baseline, 3 and 6 months post-surgery) (%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures relate to the process evaluation: 1. Number of voice therapy sessions received by each patient measured using clinical notes at the end of the study 2. Level of adherence to the PaPOV intervention within voice therapy sessions measured as the number of essential components documented in clinical notes for each session 3. Description of any adaptations or alterations made to the PaPOV intervention measured using analysis of clinical notes for each session and analysis of clinician interviews 4. The amount and completeness of home practice measured using adherence questionnaire data completed by participants at the end of their voice therapy sessions 5. Description of participating sites and participants, measured using the Case Report Form at the end of the study 6. Understand clinicians’ experiences of being trained to deliver the intervention and trial processes, measured using an analysis of clinician mentoring records and interview data with clinicians at the end of the study 7. Understand clinicians’ experiences of delivering the intervention including acceptability, barriers and facilitators measured using analysis of clinician mentoring records and interview data with clinicians at the end of the study 8. Understand participants’ experiences of trial processes measured using analysis of interview data at 6 months post-surgery 9. Understand participants’ experiences of receiving the PaPOV intervention including acceptability, barriers and facilitators measured using analysis of interview data at 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed