Randomized Controlled Trial of Voice on Children With Vocal Nodules

Vocal Fold Nodules Clinical Trial

Official title: Randomized Controlled Trial of Voice on Children With Vocal Nodules

Status Completed

Clinical Trial Summary

The primary objective of this study is to determine the impact of voice therapy on voice-related quality of life in children age 6-10 years old with apparent vocal fold nodules, as measured by the validated Pediatric Voice-Related Quality of Life Instrument (PVRQOL)administered 4 weeks after completion of voice therapy.

Clinical Trial Description

Voice disorders place over five million school-aged children at increased risk for inferior school performance, dysfunctional social development, and higher participation in criminal activities. The lesions most commonly associated with pediatric vocal dysfunction are reported to be vocal fold nodules, which are present in up to 21% of the general pediatric population and are associated with behavioral problems and inferior quality of life. Voice therapy with a speech-language pathologist is recommended by 95% of otolaryngologists for management of vocal fold nodules. When implemented, this voice therapy requires significant time investment and typically results in regular absence from the classroom over a period of 1-3 months or longer, depending on the protocol and the setting. Regular absence from school has been shown to place children at risk for poorer scholastic performance but the benefits of this voice therapy have yet to be demonstrated in any rigorous prospective, controlled trial. Thus, the most widely used treatment for the most common lesion associated with pediatric voice disorders has not been rigorously tested in a randomized controlled trial to determine whether it may have benefits.

A randomized clinical trial addressing whether voice therapy improves voice-related quality of life for children with apparent vocal fold nodules is a logical step toward developing an evidence-based treatment plan to optimize outcomes for this sizable population of at-risk children. There are currently no well-powered, prospective, controlled studies which compare voice therapy versus control in children who present with apparent nodules. Our goal is to remedy this deficiency through testing of the following primary null hypothesis: There is no difference in the change in PVRQOL scores after 3 months of treatment with voice therapy versus office instructions. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vocal Fold Nodules

• NCT number: NCT01255735
• Study type: Observational
• Source: Massachusetts Eye and Ear Infirmary
• Status: Completed
• Phase: Phase 1
• Start date: January 2011
• Completion date: November 2016