Assessing the Effects of Patient Self-Rating of Voice Quality on Voice Therapy Attendance and Outcomes

NCT05237648 | Completed DMC

• 1 other identifier: 21-01409
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effects of incorporating educational online modules into voice therapy. One of the main reasons that voice therapy fails is lack of participation and engagement from the patient's side. The researchers hope to learn if increasing patient engagement via educational online modules during this waiting period between evaluation and first therapy session is useful in increasing understanding of the therapeutic framework of voice therapy.

Conditions

Dysphonia

Outcome Measures

Primary Outcomes (2)

• Change of voice handicap perception across the 3 groups

  Will be measured by Voice Handicap Index -10 (VHI-10), a patient reported outcome measure used to record the patient's perception of impairment or handicap due to a voice problem. A score of over 10 is considered to be abnormal. The scores in all three groups will be compared and analyzed.

  Baseline (Day 1) visit, 8 - 10 week visit

• Change of Online education module acceptance across the 3 groups

  Will be measured by attendance data (number of sessions recommended versus attended, number of no shows) using the standard patient data collected according to standard of care process.

  Baseline Visit (Day 1), Last day of visit (up to 4 months from baseline)

Secondary Outcomes (3)

• Change of perceived effectiveness of voice therapy

  Baseline (Day 1) visit, 8 - 10 week visit

• Change of patient's perception on voice therapy

  Baseline (Day 1) visit, 8 - 10 week visit

• Change of perceptual voice ratings

  Baseline (Day 1) visit, 8 - 10 week visit

Study Arms (3)

Experimental Group

EXPERIMENTAL

Participants will complete an online module with content focusing on patient self-rating of vocal quality within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session;

Other: Online Voice quality education module

Sham Control Group

SHAM COMPARATOR

Participants will complete an online module within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session with content focusing on vocal hygiene.

Other: Vocal hygiene module

Control group

NO INTERVENTION

Participants will not complete an online module. The groups will be compared in terms of attendance, self-efficacy, and treatment outcome measures based on the data collected within the NYU Voice Center standard of care

Interventions

Online Voice quality education module OTHER

The novel online module the authors developed consists of a patient education on acoustic-perceptual rating of voice quality (CAPE-V), practice rating sample recordings of others' voices, and the patient's self-rating of their own voice in real time during a standard sentence-reading task. The module also includes the Self-Efficacy Scale for Voice Therapy.

Experimental Group

Vocal hygiene module OTHER

The generic online patient education module on vocal hygiene during the waiting period between their initial evaluation and their first therapy session that also includes the Self-Efficacy Scale for Voice Therapy

Sham Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• English-speaking
• Have access to technology, including Internet
• Diagnosed with dysphonia with a recommended treatment of voice therapy.
• Willingness to complete all clinical/research assessments
• Ability to give informed consent

You may not qualify if:

• Patients who undergo surgical intervention during the course of therapy Contraindications for participation in voice therapy
• Diagnosis of Parkinson's Disease or other neurodegenerative, progressive disorder (e.g., ALS)
• Previous training in acoustic-perceptual voice quality rating, for example a speech language pathology student
• Visual impairments that would prevent the completion of an online module.
• Those with self-reported moderate-profound hearing loss or deafness that would preclude them from participating in the study
• Inability to give informed consent

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Aaron Johnson, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 14, 2022
• Study Start: January 19, 2023
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Aaron.Johnson@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)