The Pre- and Post-Operative Voice therapy trial (PaPOV)

Pre and Post-Operative Voice therapy (PaPOV) for benign vocal fold lesions: Non-randomised, multicentre feasibility trial with nested process evaluation

Registry ID
ISRCTN17438192
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
Nottingham University Hospitals NHS Trust
Enrollment
40
Start date
2023-01-09
Completion date
2024-10-31
Last update
2026-08-17

Conditions

Summary

Pre and post-operative voice therapy for patients with benign vocal fold lesions

Detailed description

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. There are 7 core components to the intervention which all participants will receive and 4 additional components which clinicians will select following the assessment of participant requirements. Each component comprises a target and a number of described ingredients. All participants will take part in a minimum of two pre-operative voice therapy sessions, delivered via telehealth or face-to-face by a speech and language therapist trained in the PAPOV intervention. Participants will be given information and advice about their voice, diagnosis and surgery. The clinician and participant will develop goals for the participant's voice and the participant will be taught exercises to help produce voice in a healthy way. Participants will be instructed to follow the advice and complete exercises between voice therapy sessions. Following pre-operative voice therapy, the patient will come into the hospital to have the lesion removed from their vocal fold. All details related to the surgery will be undertaken by the hospital. The research team are not involved in the surgery. Following surgery, participants will be invited to attend post-operative voice therapy. The number of sessions will vary depending on how the patient is recovering but is likely to be between one and four sessions. The aim is to support the patient in their recovery after their operation and to improve the sound strength and stamina of the voice. Session length will vary according to patient need but sessions are likely to last between 30-60 minutes.

Interventions

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

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

Locations

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