Clinical trial NCT05878197: Effect of Semi-occluded Vocal Tract Therapy on the Phonation of Children With Vocal Fold Nodules
Official title: Effect of Semi-occluded Vocal Tract Therapy on the Phonation of Children With Vocal Fold Nodules.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Voice Disorders in Children
Vocal Nodules in Children
Hoarseness
Dysphonia
Keywords: semi-occluded vocal tract therapy
straw phonation
resonant voice therapy
vocal hygiene
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Background:

The main goal of voice therapy in children with vocal fold nodules is to improve their communication, vocal quality and wellbeing. However, in this population, efficacy or effectiveness studies of voice therapy are extremely limited and show methodological shortcomings. There is an urgent need to understand the impact of different semi-occluded vocal tract (SOVT) techniques on the multidimensional facets of voice, as these SOVT exercises are frequently used in clinical practice. The common feature of these exercises is a reduction in the cross-sectional area of the vocal tract while voicing. Results of this project will have an impact on evidence-based voice therapy in children and consequently on reimbursement agreements of the health care system in the future. This fundamental research regarding the impact of SOVT techniques on the voice can also lead to the development and improvement of SOVT techniques.

Purposes:

* The first purpose of this project is to determine and compare the short-term effect of a "non-intuitive" SOVT therapy program (straw phonation) with a more traditional "intuitive" resonant voice therapy program of one week on (a) the vocal quality, (b) the laryngeal anatomy and function, and (c) the psychosocial wellbeing in children (aged between 6 and 12 years) with vocal fold nodules using a randomized sham-controlled trial.
* The second purpose of this project is to determine and compare the long-term effect of these voice therapy programs on (a) the vocal quality, (b) the laryngeal anatomy and function, and (c) the psychosocial wellbeing of the children.

Hypotheses:

Giving the promising physics of an SOVT, a positive short-term effect of straw phonation and resonant voice therapy is hypothesized. However, the non-intuitive technique straw phonation is expected to be in favor for a pediatric population. For these exercises, semi-occlusions are created by an external tool and instructions, feedback, and self-corrections can be reduced to a minimum. These factors might lead to faster results, which might in turn reduce feelings of frustration and demotivation by the children.

Study design:

A longitudinal randomized sham-controlled trial will be used. Patients will be randomly assigned to one of the 2 treatment groups "straw phonation", "resonant voice therapy", or the control group receiving a "sham treatment".

Innovativity:

This research will be innovative because of (a) the topic and study population (SOVT in children between 6 and 12 years) which is an underexposed domain in literature; (b) the methods investigating multidimensional facets of voice (c) the randomized sham-controlled study design using a large study group, a control group receiving sham treatment, random allocation of participants and blinded assessors and (d) the combination of short-term and long-term outcome.

Participants:

Inclusion criteria and exclusion criteria are described further in the application.

Voice assessment:

A standardized and multidimensional voice assessment including both objective and subjective vocal outcomes will be performed to evaluate the participants' voice pre and post-therapy, and at 3 months and 6 months follow-up. The multidimensional voice assessment will consist of the following outcomes: (a) vocal quality, (b) laryngeal anatomy and function, and c) psychosocial wellbeing. Assessments (a) and (c) will be performed in a sound-treated room at Ghent University Hospital by speech-language pathologists experienced in voice diagnostics. Assessments (b) will be performed by experienced otorhinolaryngologist. All assessors will be blinded to group allocation and study evolution. A detailed overview of the outcome characteristics is described further in the application.

Voice therapy:

The content of the different therapy arms / interventions is described further in the application.

Statistical analysis:

Linear mixed model analyses (LMM) will be used to determine whether there is a difference in evolution between the groups over time. Post-hoc pairwise comparisons with Bonferroni corrections will uncover specific within and between group differences. Intraclass correlation coefficients models and Cohen's κ will be used to determine inter- ant intrarater reliability.

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

Primary outcomes:
measure: Change in Dysphonia Severity Index
timeFrame: pre: one day before therapy, day 0; post: immediately after last therapy session, day 4
measure: Change in Acoustic Voice Quality Index
timeFrame: pre: one day before therapy, day 0; post: immediately after last therapy session, day 4
measure: Change in Pediatric Voice Handicap Index (pVHI)
timeFrame: pre: one day before therapy, day 0; post: immediately after last therapy session, day 4
measure: Change in Overall Severity From Consensus Auditory-Perceptual Evaluation of Voice
timeFrame: pre: one day before therapy, day 0; post: immediately after last therapy session, day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East-Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Kristiane Van Lierde
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hartnick C, Ballif C, De Guzman V, Sataloff R, Campisi P, Kerschner J, Shembel A, Reda D, Shi H, Sheryka Zacny E, Bunting G. Indirect vs Direct Voice Therapy for Children With Vocal Nodules: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Feb 1;144(2):156-163. doi: 10.1001/jamaoto.2017.2618.
citation: Kapsner-Smith MR, Hunter EJ, Kirkham K, Cox K, Titze IR. A Randomized Controlled Trial of Two Semi-Occluded Vocal Tract Voice Therapy Protocols. J Speech Lang Hear Res. 2015 Jun;58(3):535-49. doi: 10.1044/2015_JSLHR-S-13-0231.
citation: Carding PN, Roulstone S, Northstone K; ALSPAC Study Team. The prevalence of childhood dysphonia: a cross-sectional study. J Voice. 2006 Dec;20(4):623-30. doi: 10.1016/j.jvoice.2005.07.004. Epub 2005 Dec 19.
citation: Meerschman I, Van Lierde K, Van Puyvelde C, Bostyn A, Claeys S, D'haeseleer E. Massed versus spaced practice in vocology: effect of a short-term intensive voice training versus a longer-term traditional voice training. Int J Lang Commun Disord. 2018 Mar;53(2):393-404. doi: 10.1111/1460-6984.12358. Epub 2017 Dec 5.