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

November 25, 2025 updated by: NYU Langone Health
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
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
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.
Sham Comparator: Sham Control Group
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
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
No Intervention: Control group
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1) visit, 8 - 10 week visit
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.
Baseline Visit (Day 1), Last day of visit (up to 4 months from baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1) visit, 8 - 10 week visit
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).
Baseline (Day 1) visit, 8 - 10 week visit
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.
Baseline (Day 1) visit, 8 - 10 week visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aaron Johnson, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-01409

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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