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Effectiveness of Combined Laryngeal Manipulation Therapy on Religious Singers ('Maddahs') with Muscle Tension Dysphonia

Protocol summary

Study aim
Investigating the effects of Combined Laryngeal Manipulation Therapy for Iranian Religious Singers ('Maddah') with Muscle Tension Dysphonia.
Design
A quasi-experimental clinical trial of the Pre-Post study type, without a control group and blinding method, is performed. Using a convenient sampling from among the Maddahs referred to speech therapy clinics of Hamadan University of Medical Sciences, 9 persons with voice disorders will be selected to be treated for a month.
Settings and conduct
The Maddahs referred to the voice and laryngeal clinic of Hamadan University of Medical Sciences, will be assessed by laryngeal stroboscopic evaluations, acoustics measurements, manual examinations of pain and muscle stiffness, vocal tract discomfort index (VTD) and Singer's Voice Handicap Index-10 (SVHI-10). After providing 12 sessions of laryngeal manipulation therapy (20-30 minute sessions, 3 times a week), again, the same tests are repeated for them and the results before and after the treatment are compared blindly, with numbering so that the rater does not know whether the results are related to before or after the intervention. ​
Participants/Inclusion and exclusion criteria
1. Maddahs with Muscle Tension Dysphonia (MTD). 2. Absence of laryngeal neurological disorders 3. None must have received any voice therapy previously. 4. Normal hearing.
Intervention groups
In this study, according to the degree of spasm and the number of extra laryngeal muscles involved in the Maddahs with MTD, different methods of laryngeal manipulation are combined depending on the patient's needs. Twelve treatment sessions of 20 to 30 minutes (3 times a week) are performed.
Main outcome variables
Reduction of extra laryngeal muscle pain and stiffness by palpation assessment; Reduction of vocal tract discomfort scores by VTD test; Decreasing the scores of the Singers Voice Handicap Index-10 (SVHI-10) test.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240102060597N1
Registration date: 2024-03-23, 1403/01/04
Registration timing: retrospective

Last update: 2024-03-23, 1403/01/04
Update count: 0
Registration date
2024-03-23, 1403/01/04
Registrant information
Name
Mohammad-Sadegh Seifpanahi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1571
Email address
ms.seifpanahi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
2023-05-22, 1402/03/01
Actual recruitment end date
2023-09-23, 1402/07/01
Trial completion date
2023-11-06, 1402/08/15
Scientific title
Effectiveness of Combined Laryngeal Manipulation Therapy on Religious Singers ('Maddahs') with Muscle Tension Dysphonia
Public title
Laryngeal Manipulation Therapy for Maddahs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Singers with MTD which be diagnosed using videostrobolaryngoscopy. . All the subjects with primary MTD There should be no evidence of laryngeal lesions of neuropathology affecting the larynx. None must have received any voice therapy previously Also, all of the singers with normal hearing.
Exclusion criteria:
male between 18-65 years old Maddah with at least 2 years experience
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 9
Actual sample size reached: 7
Randomization (investigator's opinion)
N/A
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
ethical committee of Hamadan University of Medical Sciences
Street address
Mardom
City
Hamadan
Province
Hamadan
Postal code
6516678851
Approval date
2021-11-07, 1400/08/16
Ethics committee reference number
IR.UMSHA.REC.1400.816

Health conditions studied

1

Description of health condition studied
Muscle Tension Dysphonia
ICD-10 code
R49
ICD-10 code description
Voice and resonance disorders

Primary outcomes

1

Description
Mathieson Laryngeal palpatory evaluation: The resistance and self-reported pain by the patients in different laryngeal muscles will be rated on a scale of 1 to 5, with 5 indicating the highest resistance and 1 referring to normal.
Timepoint
before the start of the intervention and immediately at the end of the last session of the intervention (about a month later)
Method of measurement
Mathieson Laryngeal Palpatory evaluation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The characteristics of muscle tension and the impact of voice disorders on the larynx and the quality of life of the Maddahs with MTD are compared before the combined manipulation of the larynx and after the intervention, and we do not have a control group. The treatment program includes 12 treatment sessions (3 times a week) for 20-30 minutes of laryngeal manipulation.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Speech Therapy Clinic of Besat Hospital
Full name of responsible person
Mohammad-Sadegh Seifpanahi
Street address
Speech therapy clinic, Besat Hospital, Besat Boulevard, Hamadan.
City
Hamadan
Province
Hamadan
Postal code
6516711146
Phone
+98 81 3838 1571
Email
panahi29@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokuhi
Street address
Research and Technology Vice-Chancellor, 4th floor, Headquarters of Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3131 4058
Email
Fanavari@umsha.ac.ir
Web page address
https://research.umsha.ac.ir/
Grant name
Faculty research plan
Grant code / Reference number
140011199614
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad-Sadegh Seifpanahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, Faculty of Rehabilitation Sciences, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۸۷
Phone
+98 81 3838 1571
Email
panahi29@gmail.com
Web page address
https://rehab.umsha.ac.ir/%D9%87%DB%8C%D8%A7%D8%AA-%D8%B9%D9%84%D9%85%DB%8C-%DA%AF%D9%81%D8%AA%D8%A7%D8%B1%D8%AF%D8%B1%D9%85%D8%A7%D9%86%DB%8C

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad-Sadegh Seifpanahi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, Faculty of Rehabilitation Sciences, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan
City
hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۸۷
Phone
+98 81 3838 1571
Email
panahi29@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad-Sadegh Seifpanahi
Position
assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, Faculty of Rehabilitation Sciences, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan
City
hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۸۷
Phone
+98 81 3838 1571
Email
panahi29@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data on non-identifying demographics such as age, medical history, etc., as well as primary treatment outcomes, will be released.
When the data will become available and for how long
Immediately after printing
To whom data/document is available
All researchers working in academic and scientific centers
Under which criteria data/document could be used
Any researcher who proves the reason for the need for data by showing an approved research plan.
From where data/document is obtainable
Dr. Mohammad Sadegh Seifpanahi
What processes are involved for a request to access data/document
The requester must prove the reason for the need for the data by showing the approved research plan. Will be sent immediately after confirmation.
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