2016, Pedrosa Et Al, The Effectiveness of Comprehensive Voice, J Voice
2016, Pedrosa Et Al, The Effectiveness of Comprehensive Voice, J Voice
Summary: Objective. To evaluate the effectiveness of the Comprehensive Voice Rehabilitation Program (CVRP)
compared with Vocal Function Exercises (VFEs) to treat functional dysphonia.
Study Design. This is a randomized blinded clinical trial.
Methods. Eighty voice professionals presented with voice complaints for more than 6 months with a functional dysphonia
diagnosis. Subjects were randomized into two voice treatment groups: CVRP and VFE. The rehabilitation program con-
sisted of six voice treatment sessions and three assessment sessions performed before, immediately after, and 1 month after
treatment. The outcome measures were self-assessment protocols (Voice-Related Quality of Life [V-RQOL] and Voice
Handicap Index [VHI]), perceptual evaluation of vocal quality, and a visual examination of the larynx, both blinded.
Results. The randomization process produced comparable groups in terms of age, gender, signs, and symptoms. Both
groups had positive outcome measures. The CVRP effect size was 1.09 for the V-RQOL, 1.17 for the VHI, 0.79 for vocal
perceptual evaluation, and 1.01 for larynx visual examination. The VFE effect size was 0.86 for the V-RQOL, 0.62 for
the VHI, 0.48 for the vocal perceptual evaluation, and 0.51 for larynx visual examination. Only 10% of the patients were
lost over the study.
Conclusions. Both treatment programs were effective. The probability of a patient improving because of the CVRP
treatment was similar to that of the VFE treatment.
Key Words: Randomized clinical trial–Voice treatment–Voice quality–Vocal quality–Voice–Speech therapy–Voice
disorders.
databases (Embase, Lilacs, PubMed, and Web of Science). throughout Greater S~ao Paulo were contacted. Paper advertise-
After reviewing the database, we identified 15 clinical trials, ments and radio calls were also used to gather volunteers. Those
five case-control studies, and five case studies that were relevant interested answered a questionnaire to confirm that they met the
to our research. Among these studies, 15 tested the effect of initial inclusion criteria. They also included signs and symptoms
VFE alone or in combination with other therapeutic tech- in e-mail responses, a method of data collection which has pre-
niques.18–20,24–35 VFE efficacy is already proven. Therefore, viously been used in other studies.16,38,39 The initial inclusion
we consider it to be the best design method. criteria were age between 18 and 50 years, professional voice
The VFE studies highlighted positive results in different user, and vocal complaint with a minimum of four signs and
outcome measures, such as vocal quality,26–28,30,34 dysphonia symptoms for more than 6 months. The final inclusion
symptoms,18,20,26,30 maximum phonation time,20,25,28,29,35 criterion was determined by the otorhinolaryngological (ENT)
acoustic parameters,24,25,27,31–34 and improvement of glottal examination confirming a behavioral dysphonia diagnosis
closure.24,25 In addition, one study used a self-assessment pro- with referral for vocal rehabilitation.
tocol, the Voice Handicap Index (VHI),18 and two other studies Subjects with acute or organic dysphonia and singing profes-
used the Voice-Related Quality of Life (V-RQOL).26,30 The sionals were excluded. Figure 1 represents the flowchart for
three articles highlighted a consistent improvement in quality study participants.
of life regarding vocal aspects26,30 as well as patients’ To ensure the CONSORT criteria,40 patients were random-
perception of a reduction in vocal disadvantage.18 ized into two groups of treatment using computer software.
Only two studies investigated indirect laryngeal image. Their Participants were submitted to three assessments and six
results indicated improvement in glottal closure as shown by the vocal rehabilitation sessions. The assessments included (1)
aerodynamic measures of phonation volume and maximum ENT evaluation, (2) self-assessment evaluation, and (3)
phonation time.24,25 No research has yet included previsual auditory-perceptual evaluation (APE).
and postvisual data of laryngeal examination.
The search of the literature also failed to find references that (1) The ENT evaluation consisted of history of the patient, na-
establish the duration of rehabilitation treatment for behavioral sofibrolaryngoscopy, telelaryngoscopy, and stroboscopy
dysphonia. According to estimates done among Brazilian pro- evaluation. For patients with an overactive gag reflex,
fessionals, vocal rehabilitation usually happen once or twice a only the flexible endoscope and stroboscopy were used
week in 40–45 minutes sessions during a period of 4–6 months, (40% of the examinations). Topical anesthetics (lidocaine
accounting for more than 10 sessions.36 In the international 4%) were applied. Digital images were stored on a hard
clinical practice, the number of sessions varies between six disk. Laryngoscope Machida (Machida Inc.) LYC30
and ten, but the length of session is not specified.11 700, Machida ENT-30PIII camera ASAP Popcam (Ma-
The small amount of evidence in the literature, the poorly chida Inc.), scanner Endodigi, 12:10:07 software Version
defined duration of treatment, the few holistic therapeutic pro- (Endodigi Inc.), WelchAllyn reference light source 501
grams properly described for behavioral dysphonia, and the (WelchAllyn Inc.), strobe Estrobolight Ecleris (Ecleris
Brazilian traditional symptomatic therapy with holistic focus Inc.), scanning equipment for Apple iMac with a processor
led us to design an exercise program called the Comprehensive Core 2Duo were used for larynx examination (Apple Inc.).
Voice Rehabilitation Program (CVRP).37 The program origi- Patients were asked to sustain the vowels /e/ and /i/ at their
nated from a research carried out by the Larynx Institute in habitual frequency and intensity. The same technique was
S~ao Paulo (INLAR) and Centre for the Study of Voice (CEV) used for immediate and 1 month after treatment assess-
in the 1990s. CVRP has been the basis of the voice clinical ments. The laryngologic examination was performed to
care of CEV, voice specialists, and UNIFESP. Therefore, it confirm the behavioral diagnosis of dysphonia and to
needs to be compared with a well-accepted program so that manage the vocal rehabilitation.
we can analyze differences between both. (2) Self-assessment evaluation consisted of the vocal
If the CVRP shows advantages or equivalence to the VFE impact analysis using the questionnaires from the
method, it could be considered as another treatment option VHI41 and V-RQOL Index.42,43
for behavioral dysphonia. (3) The perceptual auditory analysis was performed with the
recorded sustained /ae/ vowel. For the voice recording,
the microphone position was 5 cm from the mouth, at a
Objective 45 angle. The speech samples were recorded directly
To evaluate the effectiveness of the CVRP compared with VFEs into the computer (HP Pavilion ZV6000 (Hewlett Pack-
to treat functional dysphonia. ard Inc.), Athlon 64 AMD, microphone headset Genius
HS-04SU (Genius Inc.)). For the perceptual evaluation,
MATERIALS AND METHODS samples were played via a professional headset Sony
Samples and evaluations MDR-7502 model (Sony Inc.).
Participants in this study were invited to take part in the research All participants freely signed the consent form. The Ethical
through announcements at their workplaces. Companies and in- Committee of the institution approved this study, under the
stitutions employing professional voice users such as schools, number CEP 0715/10, and it was registered in the Clinical Tri-
television or radio stations, telemarketing centers, and law firms als database under the number 2010/15 166-3.
Vanessa Pedrosa, et al Voice Rehabilitation Randomized Clinical Trial 377.e13
FIGURE 1. Flowchart.
(3) Three independent speech-language pathologists, voice Of these 80 individuals, eight dropped out from treatment
specialists with extensive clinical experience (>8 years) during the therapeutic process after being randomized, three
performed the APE. They did not participate in any other were from the CVRP group, and five from the VFE. The rea-
part of the research process. Therefore, they were blinded sons for withdrawal were lack of time (n ¼ 4) or complete
to the findings. The voices were presented via headphone, loss of contact (n ¼ 2) when the patient failed to answer
without any identification included in the recording. Each scheduling calls and did not respond to e-mails. In two other
patient’s samples were presented sequentially, in a cases, the patient scheduled the sessions and did not attend
random order. A visual analog scale of 100 points in the any of them.
degree of dysphonia parameter was used, considering Among the 72 patients who completed the treatment, eight
0 to be with no vocal deviation and 100 to be the patients reported consistently doing <50% of their assigned
maximum deviation. Three speech therapists specialized home exercises. After the six-session period, 27 (37.5%) pa-
in voice therapy performed this evaluation. Each speech tients reported completely stopping or only sporadically
therapist, randomly and blindly, listened to the voices. continuing to do the exercises.
Each of the three vocal aspects received a score between Intention to treat was calculated for all patients, including the
0 and 100. Then, the average of these three aspects was eight dropout patients.
computed (APE1, APE2, and APE3). No significant difference was found between men and
women in both groups in chi-square test P ¼ 0.143 (Table 1).
No significant difference was found for signs and symptoms
RESULTS quantity between the CVRP and VFE (P ¼ 0.55; Table 2).
The study lasted 1 year and 3 months. A total of 306 volunteers Intrasubject agreement was tested with 30% of cases repeti-
who had made contact via e-mail or phone were registered and tion. The judge with highest values was kept as the single eval-
they received the list of vocal signs and symptoms.38,39 From uator 91.6% in the pretherapy samples, kappa 0.771; 87.5%
these 306 volunteers, 212 (69.28%) answered the list and immediate posttreatment, kappa 0.813; and 91.6% after 1-
were professional voice users. From these 212, 159 (51.96%) month posttreatment, kappa of 0.840.
had four or more signs and symptoms and were between the For the LP variable, there was a reduction in the two posttreat-
ages of 18 and 50 years. The 159 individuals were referred ment scores, for both treatment groups (Table 3). According to
for an initial assessment and 99 (32.35%) were evaluated. the mean, the CVRP groups showed greater improvements
Among them, 19 were excluded for not having a behavioral than the VFE group.
dysphonia diagnosis. Eighty patients (26.14%) were included The average of the results of the questionnaire also showed a
in this research, and the sample was randomized. reduction of VHI2 and VHI3, for both groups, when compared
Of the 80 enrolled patients, 56 were women with an average with VHI1. However, the greatest reduction occurred in VFE
age of 35.1 years and standard deviation of 10.1 years. There group with a difference of 3.63 points. The mean scores of
were 24 men with an average age of 35.9 years and standard de- the questionnaire V-RQOL demonstrate that there was an in-
viation of 8.7 years. The average age in the CVRP group was crease in quality of life at the immediate posttreatment assess-
34.5 years with a standard deviation of 9.03. In the VFE group, ment (V-RQOL2) and 1 month after the treatment discharge.
the average age was 36.05 years and the standard deviation of Descriptive means of perceptual evaluation showed reduced
10.37. Both groups were statistically similar (P ¼ 0.143), scores in CVRP groups for PAE2 and PAE3. In EFV, reduction
Table 1. occurred just between PAE1 and PAE2.
TABLE 1.
Participants Separated by Group, Sex, and Profession
CVRP VFE
Profession n % n % n % n % n % n %
Lawyer 2 5.0 1 2.5 3 3.8 0 0.0 0 0.0 0 0.0
Actor 1 2.5 0 0.0 1 1.3 1 2.5 0 0.0 1 1.3
SLP 0 0.0 0 0.0 0 0.0 1 2.5 0 0.0 1 1.3
Journalist 6 15.0 5 12.5 11 13.8 3 7.5 5 12.5 8 10.0
Religious leader 1 2.5 1 2.5 2 2.5 0 0.0 3 7.5 3 3.8
Professor 15 37.5 2 5.0 17 21.3 16 40.0 6 15.0 22 27.5
Teleoperator 4 10.0 0 0.0 4 5.0 4 10.0 0 0.0 4 5.0
Seller 2 5.0 0 0.0 2 2.5 0 0.0 1 2.5 1 1.3
Total 31 77.5 9 22.5 40 50.0 25 62.5 15 37.5 40 50.0
Abbreviations: CVRP, Comprehensive Voice Rehabilitation Program; VFE, Vocal Function Exercise.
377.e16 Journal of Voice, Vol. 30, No. 3, 2016
TABLE 3.
Descriptive Measures of All Variables, Presenting Three Assessments
CVRP VFE
TABLE 4.
Positive Outcomes by Group, Relative Risk With Confidence Interval and Significance Level and Size Effect for the CVRP and
VFE, Comparing the Three Assessments*
Progress % Effect Size
both groups. The analysis of dichotomous data reveals a small Only one previous study26 presented all the necessary data to
difference between the two groups, slightly favoring the CVRP, calculate the sample size (total score, mean score, mean differ-
but this difference was not statistically significant. ence, and standard deviation of the difference between before
A systematic search of the medical literature revealed that and after treatment in individuals treated with VFE); therefore,
this is the only randomized clinical trial involving multidi- V-RQOL variable is justified. The number of patients included
mensional assessment that considers CVRP and EFV thera- in the study was less than the proposed sample number (40 vs 47
peutic programs results for the treatment of behavioral in each group), for this reason, the power of the test to detect the
dysphonia. seven-point difference in the chosen variable (seven-point
This study does not have a nontreated group included. improvement difference in the V-RQOL score between the
Despite the existence of many studies reporting vocal progress CVRP group and the VFE group) was reduced to 73%. If there
of a placebo group who do not receive vocal therapy, the authors had been more patients in each group, the power of the test
believe that speech therapy has a positive impact on voice. Spe- would have been greater, and the results might have shown
cifically, positive vocal outcomes would not happen without greater statistical difference.
voice therapy. Therefore, the aim of the present study was to The expected therapeutic proposal, especially for the CVRP,
compare a new treatment with a treatment considered the involves clear stages related to the patient’s vocal quality and
gold standard in voice therapy. his/her understanding of the use of his/her voice. The patient
The CVRP, which was tested in this study, reflected the most must only start one stage once she/he has understood and
commonly used exercises used in Brazilian clinics. It has been completed the previous stage. For example, pneumophonic
well adapted culturally so it does not bear any specific cultural coordination should only be addressed once the patient has
markers. Exercises were also designed to be substituted when acquired more adequate vocal quality and resonance. However,
patients presented with difficulties to produce them, for because of technical limitations, this study did not take into ac-
example, tongue vibration. The premise of the CVRP is to un- count patients’ individual progress. Therefore, some patients
derstand the individual with a behavioral dysphonia in a broad presented incomplete improvement.
sense and to pursue a segmented learning approach during the This study proposed a treatment duration of 6 weeks, with the
therapeutic process. Treatment involves the identification, authors aware of possible restrictions in terms of measuring
awareness, and modification of negative speech habits and tech- outcomes. The 6 weeks of treatment probably did not lead to
niques to benefit voice-body association, glottal adjustment, full vocal recovery in many patients. Thus, we may conclude
resonance balance, and automation techniques. This treatment that treatment did offer individuals an understanding of good
is associated with the articulatory precision of the speech vocal practices, the ability to identify both healthy and
sounds. It affects pneumo-phono-articulatory coordination in unhealthy habits, and exercises to help control some high-
voice projection and patient’s attitude toward communication. pitched vocal changes.
The broad application of the CVRP required a clinical study Proof that the CVRP leads to positive results in the treatment
to prove its effectiveness. of behavioral dysphonia is good news for clinical practice. The
377.e18 Journal of Voice, Vol. 30, No. 3, 2016
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