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OpenTrials
Completed

NCT Number: NCT05237648

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

Attendance and adherence are established as consistent challenges in voice therapy. Specific logistical and psychological factors linked to these challenges include the interval between evaluation and initiation of treatment and components of patient motivation. The authors propose a novel online education module involving patient self-ratings of voice quality to be completed at various time points throughout the therapeutic process, including during the waiting period between initial evaluation and first treatment session. The authors hypothesize that completion of this module will increase patient understanding of the conceptual framework of therapy, provide opportunities for inclusion of patient-driven acoustic goals and establish skills in auditory and kinesthetic awareness, which are foundational to behavioral voice therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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

Primary outcomes

  1. Change of voice handicap perception across the 3 groups

    Time frame: Baseline (Day 1) visit, 8 - 10 week visit

    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.

  2. Change of Online education module acceptance across the 3 groups

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

    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.

Secondary outcomes

  1. Change of perceived effectiveness of voice therapy

    Time frame: Baseline (Day 1) visit, 8 - 10 week visit

    Self-Efficacy Scale for Voice Therapy will assess a patient's self-perception of their ability to achieve a goal. The Self-Efficacy Scale for Voice Therapy prompts patients to be "brutally honest" and rate their perceived capability to accomplish practice or generalization of skills in various daily and therapeutic situations and activities. Patients are asked to rate their certainty in these capabilities from 0 to 10, where 0 is not at all certain and 10 is extremely certain.

  2. Change of patient's perception on voice therapy

    Time frame: Baseline (Day 1) visit, 8 - 10 week visit

    Comparison of scores on the Patient Perception of Voice Therapy Questionnaire for therapy completers across the three groups as well as between those subjects who completed an online module (experimental and sham control groups) and those who did not (control group alone).

  3. Change of perceptual voice ratings

    Time frame: Baseline (Day 1) visit, 8 - 10 week visit

    CAPE-V will be used to measure experimental group patients and clinician perceptual voice rating. The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) indicates salient perceptual vocal attributes, identified by the core consensus group as commonly used and easily understood. The attributes are: (a) Overall Severity; (b) Roughness; (c) Breathiness; (d) Strain; (e) Pitch; and (f) Loudness. The CAPE-V displays each attribute accompanied by a 100- millimeter line forming a visual analog scale (VAS). The clinician indicates the degree of perceived deviance from normal for each parameter on this scale, using a tic mark.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2022
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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