Vocal Fold Nodules
Conditions
Keywords
pediatrics, voice, voice therapy, vocal therapy, hoarseness
Brief 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.
Detailed 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.
Interventions
None listed
Sponsors
Drexel University College of Medicine
Medical College of Wisconsin
The Hospital for Sick Children
Massachusetts Eye and Ear Infirmary
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
1. Eligibility is contingent on the presence of apparent vocal fold nodules, which are defined as bilateral, localized, benign, superficial growths with protrusion on the medial surface of the true vocal folds at the junction of their anterior and middle thirds. This examination is based on video-stroboscopic examination, or, in rare cases, on operative microsuspension laryngoscopy. In addition, strict
Exclusion criteria
are applied toward excluding masses that are not nodules. Defining characteristics for these inclusion criteria are based upon the evaluations of three senior otolaryngologists of each participant's exam. Children evaluated by the senior otolaryngologist at each institution suspected to have vocal fold nodules are candidates for inclusion to this study. Patient de-identified images of the stroboscopy are reviewed by each of the other two laryngologists; only those children with confirmed vocal fold nodules by the all three senior otolaryngologists will be considered for entry into this study. 2. Children 6 to10 years of age will be enrolled. The rationale for this age range was previously noted. In brief, children in this age range (a) have similar educational and social exposures; (b) will likely not yet encounter pubertal changes affecting the larynx; and (c) are relatively cognitively homogeneous. Moreover, children in this age range have the ability to cooperate with voice therapy and have also been shown to be tolerant of stroboscopic examination. Finally, the voice therapy regimen in this protocol has been shown to be clinically effective for many children in this age range. 3. Voice-related quality of life must be affected to the extent that baseline PVRQOL scores are \<87.5 (on a scale of the worst, 0, to the best, 100) at the time of entry into the trial. Based on previously published data, this subset of scores will be clearly distinct from scores in children with normal voices. In addition, scores \<87.5 represent worse than average scores among children diagnosed with vocal fold nodules. 4. Dysphonia duration prior to randomization must be at least 12 weeks, in order to ensure that vocal dysfunction is chronic in nature. 5. Hearing in better ear of 35 dB or better. 6. Agreement by informed consent from the parents and informed assent from the child participant with anticipated commitment to compliance throughout the follow up period of 3 months is necessary for enrollment which includes time commitment of up to 3 hours per week to therapy sessions and homework. 7. Vocal fold nodules are a pathology that predominantly affects males. A number of studies and the databases utilized to track this pathology at the clinical sites indicate that the male: female ratio is approximately 7:3. Given this background, the enrollment plan for the current investigation will seek to have a 30% female representation of the patients enrolled in this study to ensure appropriate gender representation. Additionally, patients with a diagnosis of pediatric vocal fold nodules predominantly are found in Caucasian populations. However, in accordance with the National Institute of Health Revitalization Act of 1993 the inclusion of minorities in this proposal will be targeted to the representation of minorities in the greater Boston, Philadelphia and Milwaukee metropolitan regions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Voice-Related Quality of Life Instrument (PVRQOL) | Administered at Screening, Baseline, Therapy Completion, and Follow-Up | The PVRQOL consists of 10 questions completed by parent proxy administration that requires approximately 5 minutes to complete. It measures the parent's assessment of their child's overall quality of life as related to their vocal condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) | Completed at Baseline, Therapy Completion, and Follow-Up | The CAPE-V specifies standardized procedures for the perceptual evaluation of voice, including standardized recording conditions, word stimuli and rating procedures. |
| Phonation Threshold Pressure (PTP) | Completed at Baseline, Therapy Completion, and Follow-Up | The aerodynamic measures obtained will focus on estimated Phonation Threshold Pressure (PTP), defined as the minimum amount of subglottal pressure required to initiate and sustain vocal fold oscillation. These measures will be obtained in a non-invasive manner from oral pressures generated during repetitive production of five consonant-vowel-consonant (CVC) strings (/pae pae pae pae pae/. |
| Harmonics-to-Noise Ration [HNR) | Completed at Baseline, Therapy Completion, and Follow-Up | Recordings will be analyzed using KayPENTAX's Computerized Speech Lab (CSL). To analyze the steady state vowel productions, the steadiest one second segment from the mid portion of each vowel production will be selected from the digitized waveform for analysis, and HNR results for that segment will be obtained using CSL software. |
| Nodule grade | Completed at Baseline and Follow-Up | A grading system for vocal fold nodules has been validated with established inter-rater reliability for nodule presence and size. The 3-point grading scale for nodule size will be used with grade 1 being small, grade 2 a moderate nodule, and grade 3 a large nodule. The contour of the nodule will also be rated as either discrete or sessile. One secondary objective of the study is to compare nodule grade across baseline and 12 (or 16) weeks. Changes in grade are compared for subjects treated with voice therapy versus office instructions alone. |
Countries
Canada, United States
Outcome results
None listed