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Effectiveness of phonation in tubes submerged in water performed via Telehealth and face-to-face: randomized blinded clinical trial

Effectiveness of the Water Resistance Therapy Protocol performed via Telehealth and face-to-face: randomized blinded clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-88shyrm
Enrollment
Unknown
Registered
2024-02-01
Start date
2021-07-14
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Voice Disorders

Interventions

This is a non-inferiority clinical trial, randomized and blinded. Water Resistance Therapy Protocol performance. The protocol consists of eight sessions applied twice a week and lasting 30 minutes. Th
2. LaxVox in usual pitch and loudness
3. LaxVox with pitch variation: third
4. Guidance for daily practice. Session 02: 1. Review of previous session exercises
3. LaxVox with pitch variation: octave
4. Guidance for daily practice. Session 03: 1. Review of previous session exercises
3. LaxVox gliding up and down, with a pause between the glide up and down
4. LaxVox with pitch and loudness accents
5. Guidance for daily practice. Session 04: 1. Review of previous session exercises
3. LaxVox gliding up and down in the same expiration
4. LaxVox singing “Happy Birthday”
5. Guidance for daily practice. Session 05: 1. Diagnosis explanation
4. Guidance for daily practice. Session 06: 1. Review of previous session exercises

Sponsors

Faculdade de Odontologia de Bauru
Lead Sponsor
Faculdade de Odontologia de Bauru
Collaborator

Eligibility

Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Participants of both genders; aged between 18-50 years old; with moderate vocal deviation; with otorhinolaryngological diagnoses of behavioral dysphonia; and who have never go through vocal therapy or the period without vocal therapy is equal or superior to six months.

Exclusion criteria

Exclusion criteria: Participants who are smokers; pregnant; in menopause; had undergone surgery in the neck and larynx; presented signs of psychogenic dysphonia; and have any auditory impairment.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: The vocal economy will be assessed using the Quasi-Output Costo Ratio measure. This measure is a ratio using the glottal contact quotient, vocal intensity, and fundamental frequency. It is expected that an increase in vocal economy values (Two-way repeated measures ANOVA - p<0.05).;Outcome result 1: The two-way repeated measures ANOVA showed that vocal economy increased in both groups similarly. Furthermore, in the one-month follow-up, the archived results kept the same.—

Secondary

MeasureTime frame
Expected outcome 2: Vocal self-assessment will be performed using the Vocal Handicap Index-30. This questionnaire has 30 negative situations. The participant has to fill out the questionnaire regarding the frequency of each situation in the last 30 days. It is expected that reduction of the total score (two-way repeated measures ANOVA - p<0.05).;Outcome result 2: The two-way repeated measures ANOVA showed that only the Face-to-Face Group decreased the Voice Handicap Index-30 total score. This decrease was kept after one month of treatment (follow-up assessment).—

Countries

Brazil

Contacts

Public ContactAngélica Emygdio Antonetti-Carvalho

Faculdade de Odontologia de Bauru

angelica.antonetticarvalho@outlook.com+55 014 32358000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)