Investigation the Effect of transcutaneous electrical stimulation voice therapy (TESVT ) on Voice features in Patients with Muscular Tension Dysphonia (MTD )
to evaluation of the Effect of transcutaneous electrical stimulation voice therapy (TESVT ) on Voice features in Patients with Muscular Tension Dysphonia (MTD )
Design
In this study, only one group of patients with MTD is involved. To identify and diagnose participants with MTD, an ENT physician which assisted in the study recruited. then The patients will be referred to the same hospital once they have been diagnosed.
Settings and conduct
This study is an experimental clinical trial study on 18 patients with MTD who are candidates for acoustic therapies in the speech therapies of Qa'im and Imam Reza hospitals from Mashhad University of Medical Sciences . The presence of MTD in the patient will be detected in collaboration with an ENT physician. The voice of each patient will be evaluated before and after the treatment using Acoustic, aerodynamic, Auditory-Perceptual (GRBAS) and Self-Assessment (VHI) scales.
Participants/Inclusion and exclusion criteria
The presence of dysphonia caused by MTD muscle tension for patients is necessary.
Intervention groups
This treatment involves the use of TES on the sternocleidomastoid muscle, cricothyroid and both sides of hyoid bone in MTD patients for 12 sessions of 20 minutes (two weekly sessions).
Main outcome variables
Acoustic voice features (fundamental frequency, jitter, shimmer, noise ratio to harmonic),
The characteristics of the aerodynamics (maximum MPT and s / z ratio)
Auditory-Perceptual Features (Degree, Violence, Self-Pollution, Weakness, Scramble) and
Voice handicap Index (Total score)
General information
Reason for update
Acronym
TESVT
IRCT registration information
IRCT registration number:IRCT20181217042016N1
Registration date:2019-02-23, 1397/12/04
Registration timing:registered_while_recruiting
Last update:2019-02-23, 1397/12/04
Update count:0
Registration date
2019-02-23, 1397/12/04
Registrant information
Name
hamide ghaemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 4351
Email address
ghaemih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the Effect of transcutaneous electrical stimulation voice therapy (TESVT ) on Voice features in Patients with Muscular Tension Dysphonia (MTD )
Public title
Investigation the Effect of transcutaneous electrical stimulation voice therapy (TESVT ) on Voice features in Patients with Muscular Tension Dysphonia (MTD )
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range is 18 to 55 years
No Smoking
Non-pregnancy
Lack of intubation history within three months before entering the research
Lack of a history of various types of laryngeal malignancies
Lack of history of surgery in the larynx
Lack of history of chemotherapy and radiotherapy in the head and neck area
The presence of dysphonia caused by muscle tension MTD
Exclusion criteria:
Infections of the respiratory system, such as colds, during the assessment process or during the respiratory tract
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Mashhad university of medical sciences
Street address
No. 5, Sremi 19 Ave, Kowsar Blvd., Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
7881236228
Approval date
2018-11-17, 1397/08/26
Ethics committee reference number
IR.MUMS.REC.1397.212
Health conditions studied
1
Description of health condition studied
muscular tension dysphonia disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
the voice features of MTD patients
Timepoint
one week before and one week after treatment
Method of measurement
the patients voice assessed by acoustic, aerodynamic, auditory perceptual evaluation and voice handicap index.
Secondary outcomes
1
Description
without second outcome
Timepoint
without second outcome
Method of measurement
without second outcome
Intervention groups
1
Description
Intervention group: For the intervention , the transcataneous electrical stimulation with two pads is used. Pads are placed on the sternocleidomastoid , cricothyroid muscles and two sides of the hyoid bone for 20 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem and Imam Reza hospital
Full name of responsible person
hamide ghaemi
Street address
No. 5, Saremi 19 Ave, Kowsar Blvd, Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
88123462827
Phone
+98 51 3881 4351
Email
hamideghaemi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad university of medical sciences. in front of Daneshgah 18 Ave, Daneshgah Blvd, Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
8812346282
Phone
+98 51 3882 3255
Email
tafaghodim@mums.ac.ir
Grant name
research deputy of Mashhad university of medical sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
hamide ghaemi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
No. 5, Saremi 19 Ave, Kowsar Blvd, Mashhad Town
City
Mashhd
Province
Razavi Khorasan
Postal code
8812346282
Phone
+98 51 3881 4351
Email
hamideghaemi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
hamide ghaemi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
No. 5, Saremi 19 Ave, Kowsar Blvd, Mashhad town.
City
Mashhad
Province
Razavi Khorasan
Postal code
8812346282
Phone
+98 51 3881 4351
Email
hamideghaemi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamide Ghaemi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
No.19,Saremi Ave., Kowsar Blvd., Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
8812346282
Phone
+98 51 3881 4351
Fax
Email
ghaemih@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the information, such as the main outcome information, can be shared.
When the data will become available and for how long
during 6 month after publishing the results.
To whom data/document is available
Only available to scholars working in scientific and academia.
Under which criteria data/document could be used
no changes can be made
From where data/document is obtainable
Refer to the correspond author and executor of this research.
What processes are involved for a request to access data/document
By submitting a request by email, to the research executor .