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

Not Applicable
Active, not recruiting
Conditions
Dysphonia
Interventions
Other: Online Voice quality education module
Other: Vocal hygiene module
Registration Number
NCT05237648
Lead Sponsor
NYU Langone Health
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
40
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental GroupOnline Voice quality education moduleParticipants 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;
Sham Control GroupVocal hygiene moduleParticipants 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.
Primary Outcome Measures
NameTimeMethod
Change of voice handicap perception across the 3 groupsBaseline (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 groupsBaseline 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 Outcome Measures
NameTimeMethod
Change of perceived effectiveness of voice therapyBaseline (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.

Change of perceptual voice ratingsBaseline (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.

Change of patient's perception on voice therapyBaseline (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).

Trial Locations

Locations (1)

NYU Langone Health

🇺🇸

New York, New York, United States

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