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Comparing the effectiveness of resonant voice therapy and manual circumlaryngeal therapy on tension reduction in patients with primary muscle tension dysphonia

Protocol summary

Study aim
Comparison of the effect of changing the physiology of voice production using the resonance voice therapy method on the reduction of laryngeal tension from different clinical aspects and comparing its results with themanual circumlaryngeal therapy method.
Design
A clinical trial with randomized double-blind parallel groups is conducted on 30 patients. For randomization, 2 blocks and lottery are used.
Settings and conduct
The place of study is head and neck clinic and speech therapy department of Amir Alam hospital, speech therapy clinic of rehabilitation faculty of Tehran University of Medical Sciences. Study in 7 stages including 1) localization of RVT method assignments; 2) selection of participants; 3) pre-treatment assessments; 4) treatment; 5) intermediate evaluations, 6) post-treatment evaluations, and 7) follow-up. Patients and assessors are blinded to the treatment groups and the researcher is blinded to the names of the participants in the statistical data.
Participants/Inclusion and exclusion criteria
Patients who, according to the joint opinion of a laryngologist and an experienced speech and language pathologist in the field of voice disorders, receive a primary muscle tension dysphonia diagnosis
Intervention groups
1. Resonant voice therapy: By creating resonant voice voice that is easy to produce with minimal effort) and using it in different communication context, it minimizes the possibility of damage to the larynx. 2. manual circumlaryngeal therapy : a treatment that balances the muscles by massaging the larynx and its surrounding areas.
Main outcome variables
Laryngeal muscle tension, larynx height, supraglottic activity, and "intensity and frequency" of discomfort in the vocal tract are primary outcomes.

General information

Reason for update
Acronym
RVT
IRCT registration information
IRCT registration number: IRCT20231024059840N1
Registration date: 2024-02-07, 1402/11/18
Registration timing: prospective

Last update: 2024-02-07, 1402/11/18
Update count: 0
Registration date
2024-02-07, 1402/11/18
Registrant information
Name
mojdeh mohamadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3337 9132
Email address
mo.mohamadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of resonant voice therapy and manual circumlaryngeal therapy on tension reduction in patients with primary muscle tension dysphonia
Public title
Comparing the effectiveness of resonant voice therapy and manual circumlaryngeal therapy on laryngeal tension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
According to the joint opinion of a laryngologist and an experienced speech and language pathologist in the field of voice disorders, and based on the results of voice history, voice self-evaluation, larynx observation, auditory-perceptual evaluation of voice and palpation, the participants will receive a primary MTD diagnosis. Be in the age range of 18 to 55 years Have normal hearing Do not have evidence of neurological diseases Do not have a history of other voice disorders (such as weakness and paralysis of the vocal folds or laryngeal cancer). do not have a history of surgery, radiation therapy, trauma and intubation in the larynx and neck, chronic pain in the neck area, burns of the head and neck, and any kind of scar in the front of the neck and around the larynx. At least 14 days before the start of the study, do not have an active infection in the larynx and upper respiratory tract At the time of the study and before that, they have not received any other voice therapy program do not have a fat and short neck so that it is possible to perform a palpation
Exclusion criteria:
have not completed any of the assessment and treatment stages of the study Their audio samples are unanalyzable for any reason In the evaluation of the palpation of all the target structures, the score of muscle tension should be reported as zero
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Randomization will be done using block, in such a way that all two people who enter the study will be placed in two treatment groups using lottery. The randomization unit is individual. Randomization tool using lottery
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluators (speech therapists other than the researcher) who evaluate the patients on 4 occasions during the study are blinded to the treatment that the patients receive. Also, the patients do not know what treatments are offered in this study, and the researcher is also blind to the patients' evaluation reports (the reports are coded).
Placebo
Not used
Assignment
Parallel
Other design features
One of the therapeutic methods used in this research (resonant voice therapy) requires designing assignments in Persian language. Therefore, one of the products of this research is the design and preparation of valid and reliable tasks in Persian language.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran. Enghelab ave. Rahabilitation school of tehran university of medical science
City
Tehran
Province
Tehran
Postal code
۱۱۴۸۹۶۵۱۱۱
Approval date
2024-02-06, 1402/11/17
Ethics committee reference number
IR.TUMS.FNM.REC.1402.212

Health conditions studied

1

Description of health condition studied
Muscle tension dysphonia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Muscle tension: The amount of tension of the paralaryngeal muscles, which can be measured by palpation.
Timepoint
Muscle tension is measured before the start of the treatment, in the third session of the treatment and at the end of the treatment and one month after the end of the treatment.
Method of measurement
Palpation

Secondary outcomes

1

Description
Vocal effort
Timepoint
Voice effort is measured before the start of the treatment, in the third session of the treatment, at the end of the treatment and one month after the end of the treatment.
Method of measurement
Vocal effort scale

2

Description
Cepstral analysis
Timepoint
It is measured before the start of the treatment, in the third session of the treatment and at the end of the treatment and one month after the end of the treatment
Method of measurement
Praat software

3

Description
Vocal fatigue
Timepoint
It is measured before the start of the treatment, in the third session of the treatment and at the end of the treatment and one month after the end of the treatment
Method of measurement
Vocal fatigue index

4

Description
Vocal strugle
Timepoint
It is measured before the start of the treatment, in the third session of the treatment and at the end of the treatment and one month after the end of the treatment
Method of measurement
The Consensus Auditory Perceptual Evaluation of Voice

5

Description
Glottal closure
Timepoint
It is measured before the start of the treatment and at the end of the treatment and one month after the end of the treatment
Method of measurement
Laryngeal stroboscopy and VALI form(form for reporting datas)

Intervention groups

1

Description
Intervention group: resonant voice therapy: This treatment method consists of 7 steps during which the patient learns how to produce resonant voice and how to use it in speech.The duration of the treatment consists of 6 sessions of 30 minutes, which are held twice a week.
Category
Rehabilitation

2

Description
Intervention group: manual circumlaryngeal therapy : In the MCT method, the patient sits on a comfortable chair; The therapist is placed next to the patient and manual therapy is performed with the therapist's superior hand and thumb and index (or middle) finger. Manual treatment starts from the target points where the patient has less pain and discomfort, but the parts that have more pain and discomfort; More attention is paid. The target points in this method are:1.hyoid bone 2. Thyrohyoid space 3. The posterior border of the thyroid lamina 4. Middle and lateral suprahyoid muscles.duration of the treatment consists of 6 sessions of 30 minutes, which are held twice a week
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir aalam hospital
Full name of responsible person
دکتر مریم خدامی
Street address
Saadi ave. Amir aalam hospital
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 6670 8103
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
Enghelan ave, rehabilitation school of tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
rehabilitation@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
Mojdeh mohamadi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Enghelan ave. Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 912 929 3894
Email
mmojdeh92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojdeh
Position
Assistant
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Enghelab ave
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 912 929 3894
Email
mmojdeh92@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojdeh mohamadi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Enghelab ave
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 912 929 3894
Email
mmojdeh92@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of evaluations and statistical data and the results of statistical analyzes will be published in articles and thesis text.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working at Tehran University of Medical Sciences
Under which criteria data/document could be used
If the researchers of Tehran University of Medical Sciences conduct a study in the common field with the present plan, they can use the documents
From where data/document is obtainable
Dr. Maryam Khodami, Faculty of Rehabilitation, Tehran University of Medical Sciences
What processes are involved for a request to access data/document
By using the application letter in which a brief description of the research is mentioned so that their research is related to the current research.
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