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

NCT ID: NCT05237648

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-19
• Study Completion Date: 2024-10-22

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.

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.

Conditions

Dysphonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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;

Group Type: EXPERIMENTAL

Online Voice quality education module

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Vocal hygiene module

Intervention Type: 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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

21-01409

Identifier Type: -

Identifier Source: org_study_id