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A multidimensional comparison of immediate effect of semi-occluded vocal tract exercises and symptomatic voice therapy on vocal function of individuals with vocal fatigue

Protocol summary

Study aim
Multidimensional comparison of immediate effect of semi-occluded vocal tract exercises and symptomatic voice therapy on vocal function of individuals with vocal fatigue
Design
A clinical trial with two parallel treatment groups, single blinded , randomized with a stratified randomization, is performed on 30 patients.
Settings and conduct
The study is conducted in Tehran, with a randomized clinical trial method in two treatment groups in parallel.
Participants/Inclusion and exclusion criteria
Final year students of speech therapy and speech and language pathologists suffering from voice fatigue according to the Persian Voice Fatigue Index, in the age range of 21 to 45 years, without neurological problems, without a history of voice therapy and professional voice training, without a history of head and neck surgery and the use of psychiatric drugs, without the presence of reflux
Intervention groups
We will have two treatment groups, including the symptomatic voice therapy group and semi occluded vocal tract exercises. Each group will be provided with 4 therapeutic techniques with the corresponding approach, and acoustic, auditory perceptual, aerodynamic, and voice self-evaluation assessments will be performed before and after the treatment. The duration of this intervention lasts 40 minutes. Four therapeutic techniques in the group of semi occluded vocal tract exercises include straw phonation in water, hand over mouth, lip trill and tongue trill, and 4 techniques in the symptomatic relaxation group include yawn-sigh, chewing, vocal fry, and focus.
Main outcome variables
jitter; shimmer; Harmonic to Noise Ratio (HNR); Cepstral Peak Prominance (CPP); Cepstral Peak Prominance Smoothed (CPPS); Dysphonia Severity Index (DSI); maximum phonation time (MPT); vocalself-assessment; The overall severity of the voice disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221113056491N1
Registration date: 2022-12-26, 1401/10/05
Registration timing: registered_while_recruiting

Last update: 2022-12-26, 1401/10/05
Update count: 0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
Rezvane نائبیان
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3308 3870
Email address
rez.nayebian@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A multidimensional comparison of immediate effect of semi-occluded vocal tract exercises and symptomatic voice therapy on vocal function of individuals with vocal fatigue
Public title
Comparison of physiologic and symptomatic voice therapy on vocal fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study Being in the age range of 21-45 years Voice complaint report by the person himself/herself Students being in the last year of speech therapy Not having professional activity in the field of voice therapy Obtaining a score greater than 23, greater than 7 and less than 7, respectively, in subtests 1 to 3 of the Persian Voice Fatigue Index Absence of neurological problems Absence of hearing problems No history of voice therapy No history of taking psychiatric drugs No history of surgery, intubation in the vocal tract and radiotherapy in the head and neck area Absence of reflux and taking medicine to control it No history of experience in professional voice training
Exclusion criteria:
Disappearance of any including criteria at the time of sampling Distortion of audio samples or tests performed for various reasons Taking part in the voice therapy session on the sampling day simultaneously Infection or congestion in the upper respiratory airway due to reasons such as cold, flu, nasal congestion, infection with covid 19 Being in the menstrual cycle for women
Age
From 21 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation method is stratified randomization. Four classes based on background variables include women with employment history less than 5 years, men with employment history less than 5 years, women with employment history more than 5 years, men with employment history more than 5 years. Random sequence generation in each class will be done using the random sequence generation website (https://www.sealedenvelope.com/). Concealment will be done by random allocation concealment using sealed opaque envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
For the blinding of the research, a speech therapy expert outside the current research project and with at least 5 years of clinical/research experience and trained to work with programs and laboratory devices will be recruited to evaluate treatment outcomes and collect data related to variables of vocal function and vocal self-assessment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
4th Floor, No 25, Hajali Alley, Shahmirzadi Ave, Mahallati Highway
City
Tehran
Province
Tehran
Postal code
1768963647
Approval date
2022-11-02, 1401/08/11
Ethics committee reference number
IR.USWR.REC.1401.186

Health conditions studied

1

Description of health condition studied
Vocal fatigue
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Jitter
Timepoint
Before intervention and immediately after intervention
Method of measurement
Acoustic analysis of voice signal with Praat software

2

Description
Shimmer
Timepoint
Before intervention and immediately after intervention
Method of measurement
Acoustic analysis of voice signal with Praat software

3

Description
Harmony to Noise Ratio
Timepoint
Before intervention and immediately after intervention
Method of measurement
Acoustic analysis of voice signal with Praat software

4

Description
Cepstral peak prominance
Timepoint
Before intervention and immediately after intervention
Method of measurement
Acoustic analysis of voice signal with Praat software

5

Description
Cepstral peak prominance smoothed
Timepoint
Before intervention and immediately after intervention
Method of measurement
Acoustic analysis of voice signal with Praat software

6

Description
Dysphonia Severity Index
Timepoint
Before intervention and immediately after intervention
Method of measurement
The score obtained from the weighted combination of parameters of maximum phonation time, highest frequency, lowest intensity and jitter of the voice signal

7

Description
Maximum Phonation Time
Timepoint
Before intervention and immediately after intervention
Method of measurement
Calculating the duration of the /a/ vowel production with stopwatch software

8

Description
Vocal self-assessment
Timepoint
Before intervention and immediately after intervention
Method of measurement
Using a researcher-made rating scale

9

Description
The overall severity of the voice disorder
Timepoint
Before intervention and immediately after intervention
Method of measurement
The Persian version of The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Each of the participants in the group of semi-occluded vocal tract exercises is taught to perform four exercises including hand-over-mouth, straw phonation in water, lip trill, and tongue trill in a row. In this way, first the researcher explains and models how to perform 4 exercises for 5 to 10 minutes so that the participant can learn to perform them as well. The participant then begins to perform each exercise and completes each for 10 minutes. The therapist monitors the performance to give feedback to the participant when necessary.
Category
Rehabilitation

2

Description
Intervention group: Each of the participants in the group of symptomatic voice therapy is taught to perform four exercises including yawn-sigh, chewing, vocal fry and focus in a row. In this way, first the researcher explains and models how to perform 4 exercises for 5 to 10 minutes so that the participant can learn to perform them as well. The participant then begins to perform each exercise and completes each for 10 minutes. The therapist monitors the performance to give feedback to the participant when necessary.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Akbar Darouie
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar DE, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0043
Email
adarouie@hotmail.com
Web page address
https://www.uswr.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Masoud Fallahi-Khoshknab
Street address
Deputy of Research and Technology, University of Social Welfare & Rehabilitation Sciences, Koodakyar DE, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2832
Email
fallahi@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Akbar Darouie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar DE, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0043
Email
adarouie@hotmail.com
Web page address
https://www.uswr.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Akbar Darouie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar DE, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0043
Email
adarouie@hotmail.com
Web page address
https://www.uswr.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Rezvane Nayebian
Position
Graduate Student of Speech Therapy
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar DE, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0043
Email
rezvane.nayebian@gmail.com
Web page address
https://www.uswr.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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