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

NCT05878197 | Completed Results DMC

• 1 other identifier: B670201936069 (BC-04563)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Voice Disorders in Children; Vocal Nodules in Children; Hoarseness; Dysphonia

Keywords

semi-occluded vocal tract therapy; straw phonation; resonant voice therapy; vocal hygiene

Outcome Measures

Primary Outcomes (4)

• Change in Dysphonia Severity Index

  The dysphonia severity index (DSI) is a multiparametric score to quantify vocal capabilities. It is based on a weighted combination of 4 voice parameters: maximum phonation time (MPT, s), highest frequency (F-high, Hz), lowest intensity (I-low, dB) and jitter (%). The DSI is constructed as 0.13 MPT + 0.0053 F-high - 0.26 I-low - 1.18 jitter +12.4. The index ranges from -5 to +5. A score above +1.6 is considered normal. A higher score corresponds with better voice quality / vocal capacities.

  pre: one day before therapy, day 0; post: immediately after last therapy session, day 4

• Change in Acoustic Voice Quality Index

  The acoustic voice quality index (AVQI) is a multiparametric score to quantify vocal quality. It is based on a weighted combination of 6 voice parameters: smoothed cepstral peak prominence (CPPS), harmonics-to-noise ratio (HNR), shimmer local (SL), shimmer local dB (SLdB), general slope of the spectrum (slope) and tilt of the regression line through the spectrum (tilt). The formula is constructed as 9.072 - 0.245 × CPPs - 0.161 × HNR - 0.470 × SL + 6.158 × SLdB - 0.071 × Slope - 0.170 × Tilt and ranges from 0 to 10. A lower score correlates with a better vocal quality.

  pre: one day before therapy, day 0; post: immediately after last therapy session, day 4

• Change in Pediatric Voice Handicap Index (pVHI)

  The pediatric voice handicap index (pVHI) is a questionnaire to investigate children's voice-related quality of life, completed by the parents. The index ranges from 0 to 92. A higher score correlates with more psychosocial impact of the voice disorder.

  pre: one day before therapy, day 0; post: immediately after last therapy session, day 4

• Change in Overall Severity From Consensus Auditory-Perceptual Evaluation of Voice

  This tool is designed to describe the severity of dysphonia by rating six parameters (overall severity, roughness, breathiness, strain, pitch, and loudness) on a visual-analog scale from 0 to 100, where 0 is considered within normal limits. A higher score corresponds with worse voice quality.

  pre: one day before therapy, day 0; post: immediately after last therapy session, day 4

Study Arms (3)

Experimental group 1 - Straw Phonation

EXPERIMENTAL

Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): straw phonation and vocal hygiene recommendations

Behavioral: Straw phonation

Experimental group 2 - Resonant Voice Therapy

EXPERIMENTAL

Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): resonant voice therapy and vocal hygiene recommendations

Behavioral: Resonant voice therapy

Control group

SHAM COMPARATOR

Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): vocal hygiene recommendations

Behavioral: Vocal Hygiene

Interventions

Straw phonation BEHAVIORAL

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

Experimental group 1 - Straw Phonation

Resonant voice therapy BEHAVIORAL

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

Experimental group 2 - Resonant Voice Therapy

Vocal Hygiene BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• nasal or ear diseases
• neurological disorders

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, East-Flanders, 9000, Belgium

Location

Related Publications (4)

• 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.

  PMID: 29270612 BACKGROUND

• 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.

  PMID: 25675335 BACKGROUND

• 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.

  PMID: 16360302 BACKGROUND

• 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.

  PMID: 29205707 BACKGROUND

MeSH Terms

Conditions

Hoarseness; Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Limitations and Caveats

It was not possible to analyze the long-term results due to high drop-out.

Results Point of Contact

• Title: drs. Anke Adriaansen
• Organization: Ghent University

anke.adriaansen@ugent.be

0471028622

Study Officials

• Kristiane Van Lierde

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 26, 2023
• Study Start: July 29, 2019
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)