Comparative study on the efficacy of symptomatic relaxation techniques, laryngeal manual therapy and combined method in voice therapy in teachers with muscle tension dysphonia
Comparative study on the efficacy of symptomatic relaxation techniques, laryngeal manual therapy and combined method in voice therapy in teachers with muscle tension dysphonia
Design
The design of the research is a randomized clinical trial.
Settings and conduct
The population studied in this study is the primary school teachers in Tehran city of who have an voice complaint. Therapeutic sessions will be hold at the private speech therapy clinic.
Participants/Inclusion and exclusion criteria
Teachers included who aged 25 to 50 years old and had no history of allergy, hearing loss, endocrine diseases, neurologic disorders, addiction, and voice therapy. They should have no catching colds and upper respiratory tract infection 1 month before initiation and duration the study. Moreover, they should not place in a menopause or menstrual period at the time of study. They excluded when they were not able to continue treatment protocols and lose any of above inclusion criteria.
Intervention groups
Teachers are randomly assigned to three groups, The first teacher who visits placed in symptomatic voice therapy, next in circumlaryngeal manual therapy, next placed in combined method
Main outcome variables
Voice handicap index; dysphonia severity index; perceptual auditory quality of voice; length of larynx; muscle tension; stroboscopic characteristic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170922036319N2
Registration date:2018-09-04, 1397/06/13
Registration timing:prospective
Last update:2018-09-04, 1397/06/13
Update count:0
Registration date
2018-09-04, 1397/06/13
Registrant information
Name
samira aghadoost
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4489 4053
Email address
samira.aghadoost@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-05, 1397/06/14
Expected recruitment end date
2018-11-05, 1397/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the efficacy of symptomatic relaxation techniques, laryngeal manual therapy and combined method in voice therapy in teachers with muscle tension dysphonia
Public title
The effect of voice therapy in improving voice quality in teachers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Teachers included who aged 25 to 50 years old
No history of allergy, hearing loss, endocrine diseases, neurologic disorders, addiction, and voice therapy.
They should have no catching colds and upper respiratory tract infection 1 month before initiation and duration the study.
No use of cigarettes, drugs and alcoholic beverages
Having voice complaint that lasted more than 3 months
Not participated in other voice therapy program
Not having a history or presence of various diseases associated with the digestive system, with the exception of gastroesophageal reflux due to its relatively high prevalence
Receive MTD diagnosis by ENT physician and speech and language pathology
They should not place in a menopause or menstrual period at the time of study.
Exclusion criteria:
They excluded when they were not able to continue treatment protocols and lose any of above inclusion criteria.
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Rehabilitation school, Darvazeh Shemiran
City
Tehran
Province
Tehran
Postal code
14738350543
Approval date
2017-12-31, 1396/10/10
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4091
Health conditions studied
1
Description of health condition studied
Muscle tension dysphonia
ICD-10 code
R49.8
ICD-10 code description
Other voice and resonance disorders
Primary outcomes
1
Description
Dysphonia severity index
Timepoint
Before, during and after treatment
Method of measurement
Acoustic analysis and formula calculation
2
Description
Grade of dysphonia
Timepoint
Before, during and after treatment
Method of measurement
Auditory perceptual judgments
3
Description
Voice handicap index
Timepoint
Before, during and after treatment
Method of measurement
Self-assessment questionnaire
4
Description
Repetition of vocal tract discomfort
Timepoint
Before and after treatment
Method of measurement
Self-assessment questionnaire
5
Description
Severity of vocal tract discomfort
Timepoint
Before and after treatment
Method of measurement
Self-assessment questionnaire
6
Description
Stroboscopic characteristic
Timepoint
Pre and post treatment
Method of measurement
Observation and perceptual judgment
7
Description
Pattern of muscle tension
Timepoint
Pre and post treatment
Method of measurement
Observation and perceptual judgment
8
Description
Muscle tension of larynx
Timepoint
Before, during and after treatment
Method of measurement
Palpation
9
Description
Length of larynx
Timepoint
Before, during and after treatment
Method of measurement
Palpatory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: symptomatic voice therapy :One of the direct approaches is symptomatic voice therapy which proposed by Boone (1971) is based on the principles of behavior therapy. This approach uses a variety of voice facilitating techniques through direct modification respiratory and phonatory systems lead to improvement in symptoms of voice production on correction of voice production symptoms and manipulates voice characteristic. The treatment techniques were presented for 10 individual sessions twice a week and each session lasted approximately 45 min
Category
Treatment - Other
2
Description
Intervention group: manual therapy: Physiologic voice therapy approach is another direct philosophy which recently has been considered in voice therapy of MTD aimed to directly alter or modify the physiology of the vocal mechanism. It seems laryngeal muscle tension imbalance is one possible physiologic cause of voice disturbances so laryngeal manual therapy can be noticed as a useful primary intervention in dysphonia, particularly MTD. In functional voice disorders muscle imbalance pressure, abnormal coordination patterns of muscles and intrinsic and extrinsic laryngeal muscles tension may change the cartilaginous structures and position of the larynx. Circumlaryngeal manual therapy proposed by Aronson is the first laryngeal manual therapy technique which has been gained more attention.The treatment techniques were presented for 10 individual sessions twice a week and each session lasted approximately 45 min.
Category
Treatment - Other
3
Description
Intervention group: combined method: Combined approaches combine one or more therapies to treat patients with voice impairment. The treatment techniques were presented for 10 individual sessions twice a week and each session lasted approximately 45 min
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralam hospital
Full name of responsible person
Dr. Maryam Khoddami
Street address
Amiralam hospital, Saadi St., Enghelab St.
City
Tehran
Province
Tehran
Postal code
66706106
Phone
+98 21 6672 7060
Email
hamiralam@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Maryam Khoddami
Street address
Amiralam hospital, Saadi St., Enghelab St.
City
Tehran
Province
Tehran
Postal code
66706106
Phone
+98 21 4489 3073
Email
khoddami@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Samira Aghadoost
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Speech therapy department, Tehran University of Medical Sciences Rehabilitation Faculty, Pich Shemiran, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1482546
Phone
+98 21 4489 3073
Email
khoddami@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samira Aghadoost
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Speech therapy department, Tehran University of Medical Sciences Rehabilitation Faculty, Pich Shemiran, Enghelab St.
City
Tehran
Province
Tehran
Postal code
64+654
Phone
+98 21 4489 3073
Email
khoddami@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samira Aghadoost
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Rehabilitation School, Pich Shemiran, Enghelab St.
City
Tehran
Province
Tehran
Postal code
14723556
Phone
+98 21 4489 4053
Fax
Email
khoddami@tums.ac.ir
Web page address
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
No more information
Study Protocol
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Part of the information about the outcome of the treatments will be mentioned
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
For scholars working in academic institutions
Under which criteria data/document could be used
It can be used by mentioning the name and source of the published articles simply .
From where data/document is obtainable
Samira Aghadoost
samira.aghadoost@gmail.com
Tehran university of medical sciences
What processes are involved for a request to access data/document
Email for
samira.aghadoost@gmail.com and Wait for answers in less than a month