NCT02217111CompletedNot Applicable
Prospective Study of Voice Therapy in Children: A Pilot Study
University of Pittsburgh2 sites in 1 country12 target enrollmentStarted: January 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Pediatric Voice-Related Quality of Life Survey (PVRQOL)
Study Overview
Brief Summary
The purpose of this prospective study is to obtain preliminary data on changes in pre-post voice therapy outcomes in children diagnosed with vocal fold nodules, as a function of a series of cognitive operations. The primary outcome is voice-related quality of life (questionnaire). Secondary outcomes are standard acoustic and aerodynamic measures derived from sustained vowel and running speech samples.
Detailed Description
- Voice disorders are the most common communication disorder across the lifespan, affecting more than 5 million school-aged children annually in the United States.
- Vocal fold nodules are the most frequent pathology affecting voice in children, and may affect up to 21% of the pediatric population at any given point in time.
- Children with voice disorders caused by this and other conditions often experience negative consequences in quality of life and academic participation.
- Specifically, these children are at increased risk for inferior school performance, dysfunctional psychosocial development, and other negative sequelae.
- Overwhelmingly, the first-line treatment for voice problems due to nodules is behavioral voice therapy.
- Unfortunately, the pediatric population is badly underserved by Speech-Language Pathology for this condition and others affecting voice.
- Moreover, to date, experimental findings on the benefits of voice therapy in children have not been reported.
- In the present study, children who present with voice complaints to the Department of Otolaryngology at Children's Hospital of Pittsburgh (CHP), who are diagnosed with vocal fold nodules, and who following informed consent are found to satisfy other inclusion criteria detailed shortly, will be eligible for participation in the study.
- Eligible children will undergo a 45-60-min battery of standardized tests evaluating simple cognitive functions.
- Participation in the protocol will not depend on the outcome of these tests.
- Then, all children will receive an increasingly used, 9-week program of voice therapy for children with vocal fold nodules and other conditions affecting voice, "Adventures in Voice," a program grounded in basic biomechanical, biological, and cognitive science.
- Dependent variables will be pre- to post-therapy change in voice-related quality-of-life, based on the Pediatric Voice-Related Quality of Life Survey (Boseley, Cunningham, Volk, & Hartnick, 2006) (primary outcome measure) and change in a series of standard acoustic and aerodynamic measures based on sustained vowel and simple running speech samples, described shortly (secondary outcome measures).
- The independent variables involve a series of cognitive measures.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of vocal fold nodules.
- •Age 4-11 yr.
- •Informed Consent.
- •English comprehension and production sufficient to participate in the protocol and in voice therapy.
- •Considered behaviorally and cognitively appropriate by the ear, nose, and throat physician and speech-language pathologist for voice therapy.
- •Parent and child willingness to participate in all aspects of the protocol and voice therapy.
Exclusion Criteria
- •Co-morbid medical conditions or medications that would mask or amplify the outcome of voice therapy, including (a) developmental or other neuromuscular conditions, (b) major illness, chronic or acute, with the exception of laryngopharyngeal reflux disease (LPR) or allergies and their treatments, which are common in both children and adults with voice disorders, thus their exclusion would severely restrict the participant pool and, moreover, threaten external validity.
- •Hearing loss: > 20 dB hearing loss at 1000, 2000, 4000 Hz in at least one ear.
Arms & Interventions
voice therapy
Experimental
Intervention: Adventures in Voice: Pediatric Voice Therapy (Behavioral)
Outcomes
Primary Outcomes
Pediatric Voice-Related Quality of Life Survey (PVRQOL)
Time Frame: 13-16 weeks
The PVRQOL is a 10-item instrument designed and validated as a self-administered and parent-proxy-administered instrument for the pediatric population with voice disorders to measure both social-emotional and physical-functional aspects of voice problems. The PVRQOL raw scores are transformed to a scale of 0-100 for easy of interpretation. The PVRQOL will be administered prior to initiation of voice therapy as well as one week post-voice therapy termination.
Secondary Outcomes
- Developmental Neuropsychological Assessment (NEPSY) (Cognitive Assessment)(13-16 weeks)
- Vital Capacity (Aerodynamic Analysis)(13-16 weeks)
- Browns ADD Scales (Cognitive Assessment)(13-16 weeks)
- Maximum Phonation Time (Aerodynamic Analysis)(13-16 weeks)
- Children's Memory Scale (Cognitive Assessment)(13-16 weeks)
- Spectral and Cepstral Analysis(13-16 weeks)
- S/Z Ratio (Aerodynamic Analysis)(13-16 weeks)
Investigators
Kittie Verdolini Abbott
Professor
University of Pittsburgh
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Randomized Controlled Trial of Voice on Children With Vocal NodulesVocal Fold NodulesNCT01255735Massachusetts Eye and Ear Infirmary114
Completed
Not Applicable
Immediate Effect Analysis of Vocal TechniquesVoice DisordersNCT00961818Tuiuti University of Paraná32
Completed
Not Applicable
Analysis about the effect of voice therapy for vocal fold paralysis after esophagectomyVocal fold paralysisJPRN-UMIN000037097Kansai Medical University60
Completed
Not Applicable
New Therapeutical Perspectives in Cases of Phonological DisordersSpeech Sound DisordersNCT02935062Universidade Federal de Santa Maria24
Unknown
Not Applicable
Augmenting Treatment Effects of Voice Therapy in Parkinson DiseaseParkinson DiseaseNCT02265315Le Bonheur Children's Hospital70