N/A
N=30
Effect of Semi-occluded Vocal Tract Therapy on the Phonation of Children With Vocal Fold Nodules
Voice Disorders in Children · Vocal Nodules in Children · Hoarseness · Dysphonia
Bottom Line
View on ClinicalTrials.gov: NCT05878197 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Change in Dysphonia Severity Index — 1.8; 1.8; 0.0 units on a scale — p=0.024
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Straw phonation (Behavioral); Resonant voice therapy (Behavioral); Vocal Hygiene (Behavioral)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- University Hospital, Ghent
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Dysphonia Severity Index |
1.8; 1.8; 0.0 | 0.024 sig |
| PRIMARY Change in Acoustic Voice Quality Index |
-0.1; -0.4; -0.3 | 0.107 |
| PRIMARY Change in Pediatric Voice Handicap Index (pVHI) |
-3.3; -3.9; -1.7 | 0.024 sig |
| PRIMARY Change in Overall Severity From Consensus Auditory-Perceptual Evaluation of Voice |
-6.5; -0.7; -1.0 | 0.115 |
Summary
The goal of this clinical trial is to determine and compare the effects of different voice therapy programs in children with vocal fold nodules. Vocal fold nodules are non-cancerous growths on the vocal folds which cause hoarseness. The main questions this trial aims to answer are:
* What are the short-term effects of the new voice therapy program 'straw phonation' and a more traditional 'resonant voice therapy' program on (a) the vocal quality, (b) the size of the growths on the vocal folds, and (c) the overall functioning in children with vocal fold nodules? During straw phonation exercises, you make sound through a drinking straw. During resonant voice therapy exercises or 'humming', you make an 'm' sound as you breathe out.
* What are the long-term effects of these voice therapy programs?
Participants will receive a short-term intensive voice therapy program of four days. The researchers will compare the straw phonation group, resonant voice therapy group and control group to see if voice therapy works well in treating children with vocal fold nodules.
The researchers hypothesize that straw phonation will have better results than resonant voice therapy. Straw phonation exercises are easier for children because they use an external tool (the straw) and less self-correction is needed.
Eligibility Criteria
Inclusion Criteria
- children aged between 6 and 12 years (primary school)
- diagnosed with vocal fold nodules by an otorhinolaryngologist and speech-language pathologist experienced in voice diagnostics.
Exclusion Criteria
- nasal or ear diseases
- neurological disorders
Data sourced from ClinicalTrials.gov (NCT05878197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.