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Clinical Trials/NCT05237648
NCT05237648
Completed
Not Applicable

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

NYU Langone Health1 site in 1 country42 target enrollmentJanuary 19, 2023
ConditionsDysphonia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dysphonia
Sponsor
NYU Langone Health
Enrollment
42
Locations
1
Primary Endpoint
Change of voice handicap perception across the 3 groups
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 19, 2023
End Date
October 22, 2024
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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

  • Change of perceived effectiveness of voice therapy(Baseline (Day 1) visit, 8 - 10 week visit)
  • Change of perceptual voice ratings(Baseline (Day 1) visit, 8 - 10 week visit)
  • Change of patient's perception on voice therapy(Baseline (Day 1) visit, 8 - 10 week visit)

Study Sites (1)

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