CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Straw phonation +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05878197
NCT05878197N/ACompleted

Effect of Semi-occluded Vocal Tract Therapy on the Phonation of Children With Vocal Fold Nodules.

University Hospital, Ghent·interventional·Posted May 26, 2023·Updated Oct 10, 2024

In Brief

A clinical study evaluating Straw phonation, Resonant voice therapy, and 1 other intervention for Voice Disorders in Children and 3 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 26, 2023
Enrollment StartJul 29, 2019
Primary CompletionApr 3, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 3.1 years ago

Interventions

Straw phonationbehavioral

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

Resonant voice therapybehavioral

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

Vocal Hygienebehavioral

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