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The effect of semi-occluded vocal tract treatment methods on improving voice quality in patients with unilateral vocal fold paralysis.

Protocol summary

Study aim
In the present study, the overall goal is to investigate the effect of semi-occluded vocal tract treatment methods on improving the voice quality of patients with unilateral vocal fold paralysis, based on comparing the changes in acoustic, perceptual-auditory, aerodynamic, and self-assessment parameters based on the Persian version of the VAPP (voice activity and participation profile) questionnaire before and after treatment.
Design
To determine the participants and select the sample, convenience sampling method is used. Based on the base frequency with a difference before and after of 20, standard deviation of 25, power of 80% and confidence level of 95%, the minimum sample size is 15 patients in a treatment group.
Settings and conduct
The study population consists of patients with unilateral vocal fold paralysis who refer to treatment centers in Shiraz during the study period. 15 patients will receive 10 treatment sessions at Chamran and Motahari treatment centers in Shiraz.
Participants/Inclusion and exclusion criteria
In this study, a group of 15 patients with unilateral vocal fold paralysis was included, whose vocal fold paralysis was confirmed by an otolaryngologist.
Intervention groups
we investigated the effect of semi-occluded vocal tract treatment methods on improving the voice quality of patients with unilateral vocal fold paralysis, based on comparing the changes in acoustic, perceptual-auditory, aerodynamic, and self-assessment parameters based on the Persian version of the VAPP questionnaire before and after treatment on a group of 15 patients with unilateral vocal fold paralysis. In this study, we did not have a control group.
Main outcome variables
semi-occluded vocal tract therapy, unilateral vocal fold paralysis disorder, perceptual-auditory quality of voice, acoustic quality of voice, and aerodynamic evaluation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250227064867N1
Registration date: 2025-03-06, 1403/12/16
Registration timing: prospective

Last update: 2025-03-06, 1403/12/16
Update count: 0
Registration date
2025-03-06, 1403/12/16
Registrant information
Name
Minoo Kargarfard Esfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 2700
Email address
minoo.fardesfahani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-03, 1404/01/14
Expected recruitment end date
2025-04-19, 1404/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of semi-occluded vocal tract treatment methods on improving voice quality in patients with unilateral vocal fold paralysis.
Public title
The effect of semi-occluded vocal tract treatment methods on improving voice quality in patients with unilateral vocal fold paralysis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of unilateral vocal fold paralysis disorder by the main operator and otolaryngologist based on stroboscopy observations. Vocal fold paralysis within 3 months after thyroid surgery. No history of voice therapy, medication, or any surgical or medical treatment due to unilateral vocal fold paralysis, based on the medical record, The age range of patients with unilateral vocal fold paralysis is between 18 and 65 years, No history of head trauma, stroke, or head surgery based on medical records, Absence of paresis in the contralateral crease based on stroboscopy and interpretation by an otolaryngologist, No oscoliosis and severe lordosis in patients, No history of other functional and vocal organ disorders, No history of respiratory diseases including asthma and dyspnea, No history of psychopathy and use of neuroleptics and sedatives, No neurogenic diseases such as Parkinson's, Unwillingness to participate or continue treatment at any stage will lead to the patient's withdrawal from the study, Occurrence of stroke or any neurological disorder during treatment and study.
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences Central Building, Opposite Palestine Street, Zand Street, Shiraz.
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2025-02-22, 1403/12/04
Ethics committee reference number
IR.SUMS.REC.1403.542

Health conditions studied

1

Description of health condition studied
Unilateral vocal fold paralysis
ICD-10 code
G53.8*
ICD-10 code description
G53.8* Cranial nerve disorders in diseases classified elsewhere. Other cranial nerve disorders in other diseases classified elsewhere.

Primary outcomes

1

Description
Improving sound quality based on the results of acoustic, perceptual-auditory, aerodynamic, and self-assessment parameters based on the Persian version of the VAPP questionnaire.
Timepoint
Before starting treatment, at the end of the last treatment session, and one month after completing treatment sessions.
Method of measurement
Evaluation of acoustic parameters using data from PRAAT software using the patient's recorded voice. Evaluation of perceptual-auditory parameters based on the GRBAS assessment form score. Evaluation of acoustic parameters based on the maximum duration of vocalization obtained by a timer. Evaluation of self-assessment using the score obtained from the Persian version of the VAPP questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: There is an intervention group consisting of 15 patients with unilateral vocal fold paralysis, all of whom receive 10 sessions of semi-occluded vocal tract therapy. These patients will be assessed at 3 stages to assess the effect of these therapies on the improvement of their vocal fold paralysis: before the start of treatment, at the end of the last treatment session, and one month after the end of the treatment sessions. The audiological assessments include perceptual-auditory assessment, acoustic assessment, aerodynamic assessment, and self-assessment. In this study, we do not have any control group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Dr. Kamyar Iravani
Street address
next to Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
Phone
+98 71 3612 1000
Email
motahari@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Hamid Mohammadi
Street address
Shiraz University of Medical Sciences Central Building, Opposite Palestine Street, Zand Street, Shiraz.
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3235 7282
Email
mohammadi219@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Salime Jafari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Professors Building, Faculty of Rehabilitation Sciences, Shahid Doran Campus, after Amir al-Momenin (AS) Burn Injury Hospital, Shiraz, Shahr Sadra Road.
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
SaJafari@Sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Salime Jafari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Professors Building, Faculty of Rehabilitation Sciences, Shahid Doran Campus, after Amir al-Momenin (AS) Burn Injury Hospital, Shiraz, Shahr Sadra Road.
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
SaJafari@Sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Minoo Kargarfard Esfahani
Position
Speech therapist
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Eram 6 Dormitory, Shiraz Medical Sciences Girls' Dormitory Complex, Shiraz University, Eram Square, Shiraz.
City
Shiraz
Province
Fars
Postal code
7194685791
Phone
+98 71 3628 2700
Fax
Email
minoo.fardesfahani@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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