The Pre and Post-Operative Voice Therapy Trial (PaPOV)
Research type
Research Study
Full title
Pre and Post-Operative Voice therapy (PaPOV) for benign vocal fold lesions: Non-randomised, multicentre feasibility trial with nested process evaluation
IRAS ID
295725
Contact name
Vicky Booth
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
ISRCTN Number
ISRCTN17438192
Duration of Study in the UK
2 years, 0 months, 23 days
Research summary
Research Summary:
Voice problems can be caused by benign lumps or bumps growing on the vocal folds. These can prevent the vocal folds from closing fully or vibrating normally, causing hoarseness, voice loss, pain or strain in the throat. Vocal fold polyps, cysts and papilloma are examples of these lumps, which collectively are called ‘benign vocal fold lesions’.Treatment for benign vocal fold lesions varies. Evidence suggests that patients may benefit from voice therapy before and after an operation but what voice therapy entails for these patients is poorly described. We have undertaken research with patients and clinicians to develop a voice therapy treatment programme for patients having surgery on their vocal folds.
We now need to see whether this voice therapy treatment is acceptable and useful to patients and clinicians. We need to understand whether it is feasible to run a study where patients who are having surgery, also receive this voice therapy treatment. This study will recruit 40 patients from two NHS trusts in England who are having surgery on their vocal folds. We will consider whether patients are happy to take part in this study, whether they complete the treatment, and what they think about the treatment. Patients will take part in the initial intervention and then patients and clinicians will take part in an optional interview. We will use this information to help decide whether a larger trial would be useful in the future to evaluate the effectiveness of this voice therapy treatment.
Lay summary of study results:
BACKGROUND:
Voice disorders affect one in three people during their lifetime. Time off work alone costs the UK £200 million each year. Patients with voice disorders can suffer considerable social, emotional and financial consequences. There are many different reasons why people develop a voice problem. Some individuals develop benign vocal fold lesions (BVFLs) such as polyps and cysts. These grow on the vocal folds, which sit inside the voice box. BVFLs prevent the vocal folds from closing or vibrating properly and can make the voice sound rough, hoarse or strained. Treatment for BVFLs is variable. Some patients are offered surgery, some voice therapy and some a combination of treatments. Some evidence suggests that the best outcomes occur when surgery is accompanied by voice therapy. Voice therapy could help prepare patients for surgery, speed up recovery (facilitating return to work), reduce permanent disability and prevent recurrence. However, what constitutes ‘voice therapy’ for patients with BVFLs has not been well described. Without good descriptions of the treatment it is hard to design research to measure how effective a treatment is. To address this problem, the Pre- And Post-Operative Voice therapy (PAPOV) intervention was developed. Developing this involved examining the best available research and involving patients and clinicians in the design of the treatment. This voice therapy treatment is intended to be delivered to patients before and after they had surgery on their vocal folds. The PAPOV intervention comprises seven essential and four additional parts to the treatment. This includes things like providing information, working on a patient’s understanding about how to change their voice and practicing exercises to retrain muscle patterns. Having developed the intervention, a training package for clinicians and a manual to follow, it was time to test out the PAPOV intervention in patients who were having surgery on their vocal folds.
METHODS:
A feasibility trial was conducted in two NHS sites and aimed to recruit 40 patient participants. All participants in the trial received the PAPOV intervention. The objectives of the trial were to consider whether patients could be recruited to the trial, whether they remained in the trial and if the treatment that they received contained all the components detailed in the PAPOV intervention manual. It also investigated whether participants practiced their voice therapy exercises and stuck to the advice they were given between voice therapy sessions. Recordings of participants voices and questionnaires were used to measure changes in the participants’ voices and their quality of life. Questionnaires also asked the participants about the costs incurred as a result of having a voice problem, such as time off work and travelling to attend appointments.
A process evaluation was used to understand more about the way in which the PAPOV intervention was delivered, such as the number and length of voice therapy session, and the content of each session. Interviews with patient participants and clinicians explored their views around how acceptable the PAPOV intervention was and what things made it easier or harder to do.
RESULTS:
All of the objectives of the trial were met. A total of 41 patients from two hospitals were recruited to the trial. Six patients dropped out before they reached the end of the study. The proportion of questionnaires completed, and voice recordings made by participants remained at over 80% throughout the trial. Clinicians delivered the PAPOV intervention as described in the treatment manual, with 93% of participants receiving all seven essential parts of the PAPOV intervention.
There was a statistically significant change in all questionnaires completed by participants before and after treatment. There were also significant changes in the sound of the voice as rated by both clinician and acoustic measures of voice before and after treatment. Changes in how long a patient could hold a vowel sound for and changes in pitch range did not reach statistical significance. Interviews revealed high levels of acceptability to both the clinicians delivering the treatment and to the participants receiving the treatment. It also identified a number of things which both helped and hindered participants’ ability to carry out and stick to the therapy.
Seven patients reported voice improvement during their pre-operative voice therapy and re-examination of their voice box showed that their BVFL had resolved. This meant that they no longer needed to have surgery.
CONCLUSION:
The PAPOV intervention is a detailed voice therapy intervention for adults with BVFLs undergoing phonosurgery. Feasibility testing showed that it was feasible and acceptable to clinicians and to individuals with a range of different BVFLs. It is now appropriate to consider undertaking further research which considers the clinical and cost-effectiveness of the PAPOV intervention.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0859
Date of REC Opinion
8 Dec 2022
REC opinion
Further Information Favourable Opinion