Effect of Semi-occluded Vocal Tract Therapy on the Phonation of Children With Vocal Fold Nodules
Condition: Voice Disorders in Children; Vocal Nodules in Children; Hoarseness; Dysphonia
MeSH terms: Dysphonia; Hoarseness; Voice Disorders
Study type: Interventional

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.
    

Intervention name(s): Straw phonation; Resonant voice therapy; Vocal Hygiene
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The two experimental groups will receive either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions will be equal for the three programs. In each session, vocal rest pauses will be foreseen by playing games, performing drawing assignments, etc. This will make the therapy more pleasant and less intensive. All voice therapy programs will be guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, straw phonation on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, straw phonation on word and sentence level, pitch variations Day 4: straw phonation in spontaneous speech, combination exercises; The two experimental groups will receive either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions will be equal for the three programs. In each session, vocal rest pauses will be foreseen by playing games, performing drawing assignments, etc. This will make the therapy more pleasant and less intensive. All voice therapy programs will be guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, resonant voice therapy on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, resonant voice therapy on word and sentence level, pitch variations Day 4: resonant voice therapy in spontaneous speech, combination exercises; Participants of the control group will receive a sham treatment, including the exact same games, drawing assignments, etc. as in the experimental groups. However, no SOVT or other active vocal techniques will be practiced. Vocal hygiene guidelines (e.g. avoid screaming, imitating voices, sufficient hydration etc.) will be kept equally in the four groups. All voice therapy programs will be guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations Day 3: breathing exercises, vocal hygiene recommendations Day 4: combination exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: semi-occluded vocal tract therapy; straw phonation; resonant voice therapy; vocal hygiene