Voice Therapy Per the Rehabilitation Treatment Specification System
ConditionMuscle Tension Dysphonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorMassachusetts General Hospital
About this trial
The goal of this study is to evaluate if using evidence-based, standard ingredient and target codes from the Rehabilitation Treatment Specification System - Voice Therapy (RTSS-Voice) in standard of care voice therapy documentation can improve outcomes for patients with muscle tension dysphonia (MTD). The main question it aims to answer is: Since the RTSS-Voice will help clinicians think about their treatment more specifically and in relation to nine evidence-based therapies, will its adoption be associated with improved outcomes? Clinicians across five voice centers will be asked to use the RTSS-Voice to document their voice therapy sessions for patients with MTD. Researchers will compare changes in outcomes between two groups of patients: those treated during the clinician's first year using the RTSS-Voice versus those treated during the clinician's second year using the RTSS-Voice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of primary Muscle Tension Dysphonia (pMTD)
Patients with pMTD will be included regardless of subtype (e.g., functional aphonia, vocal fry, ventricular dysphonia) and they can have secondary diagnoses of reflux.
Disqualifiers
Patients diagnosed with pMTD will be excluded if they have secondary diagnoses related to structural, neurological, or respiratory disorders such as laryngitis, obvious vocal fold nodules, polyps, cyst, granuloma, sulci, paradoxical vocal fold motion, chronic cough, confirmed or possible upper airway paralysis/paresis, dysphagia, polypoid corditis, keratosis, presbylarynx, leukoplakia, or history of radiation to the head/neck. Patients with pMTD will be included regardless of subtype (e.g., functional aphonia, vocal fry, ventricular dysphonia) and they can have secondary diagnoses of reflux.
Non-English speakers. The RTSS-Voice's standard and operationalized categories are in English.
Trial design
Design model
Sequential
Treatments tested in this trial
Standard of care voice therapy with novice clinician RTSS-Voice documentation
BehavioralVoice therapy is individually tailored to each patient and typically includes behavioral ingredients (e.g., applying pressure to the anterior neck, practice voicing in various ways, feedback on performance, provide information on the importance of therapy concepts) to modify the patient's auditory, somatosensory, vocal, musculoskeletal, respiratory, and mental functions. During this time, the treating clinicians will be trained to use the RTSS-Voice in their clinical documentation.
Standard of care voice therapy with expert clinician RTSS-Voice documentation
BehavioralVoice therapy is individually tailored to each patient and typically includes behavioral ingredients (e.g., applying pressure to the anterior neck, practice voicing in various ways, feedback on performance, provide information on the importance of therapy concepts) to modify the patient's auditory, somatosensory, vocal, musculoskeletal, respiratory, and mental functions. During this time, the treating clinicians will have completed their RTSS-Voice training and using the RTSS-Voice in their clinical documentation.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: First Year of RTSS-Voice useExperimental treatment 1 intervention
Group B: Second Year of RTSS-Voice useExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Voice Health Index (VHI)
The VHI consists of 30 Likert questions ranging from 0-4 (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always) that estimate how the patient's vocal function effects his/her daily life. A short-form can be used (the VHI-10) that uses a subset of 10 questions from the 30 total questions. This patient-reported outcome measure will be used to evaluate if the patients perceive that therapy helped them function better in their activities of daily living.
Time frame
pre-intervention and immediately after the intervention2
Voice-Related Quality of Life (V-RQOL)
The V-RQOL consists of 10 Likert-style questions ranging from 1-5 (1 = none not a problem at all, 2 = a small amount, 3 = a moderate (medium) problem, 4 = a lot, 5 = problem is "as bad as it can be") that estimate how the subject's vocal function effects his/her daily life. This patient-reported outcome measure will be used to evaluate if the patients perceive that therapy helped them function better in their activities of daily living.
Time frame
pre-intervention and immediately after the intervention3
Consensus Auditory Perceptual Evaluation of Voice (CAPE-V)
The CAPE-V consists of 4 perceptually judged 100-mm visual analog scales (Overall dysphonia, Breathiness, Strain, Roughness). The patient's treating voice specialized speech-language pathologist will judge the audio samples. These judgements provide gold-standard, perceptual ratings of voice quality to evaluate if voice therapy is associated with improved voice quality.
Time frame
pre-intervention and immediately after the intervention4
Grade Roughness Breathiness Asthenia Strain (GRBAS) Scale
The GRBAS consists of 5 perceptually-judged scales (Grade, Roughness, Breathiness, Asthenia, Strain) on a 0-3 Likert scale (0 = normal, 1 = mild severity, 2 = moderate severity, 3 = severe). The patient's treating voice specialized speech language pathologist will judge the audio samples. These judgements provide gold-standard, perceptual ratings of voice quality to evaluate if voice therapy is associated with improved voice quality.
Time frame
pre-intervention and immediately after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Emory University
Collaborator
New York University
Collaborator
University of Utah
Collaborator
University of Wisconsin, Madison
Collaborator
Source ClinicalTrials.gov