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Effectiveness of intensive laryngeal manual therapy on quality of voice in patients with muscle tension dysphonia

Protocol summary

Study aim
Investigating the effects of manual massage therapy in the form of intensive sessions (12 sessions (6 sessions per week)) on voice quality in people with dysphonia caused by muscle tension.
Design
The design of the study is single subject and each person is considered as her own control and we do not have a control group and treatment will be provided to all people.
Settings and conduct
Acoustic room of Hamadan Medical Sciences Rehabilitation Faculty
Participants/Inclusion and exclusion criteria
Dysphonic participants who have muscle tension. They do not have polyps, nodules, spasmodic dysphonia, chronic fatigue syndrome, and a history of thyroid surgery (determined by laryngoscopy) and have type 1 MTD. Patients should not have any surgery history, temporomandibular joint problems, short neck, neurological and behavioral problems.
Intervention groups
In the first phase, no intervention is provided and the individual's speech sample is recorded for six days and every other day at three points for perceptual and acoustic evaluation. In the intervention phase, which includes 12 sound therapy sessions, MCT and LMT treatments will be provided. During the intervention, data collection is done at 6 points by perceptual and acoustic evaluation. During the follow-up phase, the basic evaluation process will be repeated.
Main outcome variables
maximum phonation time, jitter, shimmer, fundamental frequency, first formant, harmonic to noise ratio, Pain level, TENs level, GRBAS scores, age, sex, intervention

General information

Reason for update
Acronym
MTD
IRCT registration information
IRCT registration number: IRCT20230403057804N2
Registration date: 2023-07-03, 1402/04/12
Registration timing: retrospective

Last update: 2023-07-03, 1402/04/12
Update count: 0
Registration date
2023-07-03, 1402/04/12
Registrant information
Name
Kowsar Baghban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1571
Email address
baghban.kowsar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-25, 1402/04/04
Expected recruitment end date
2023-07-01, 1402/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of intensive laryngeal manual therapy on quality of voice in patients with muscle tension dysphonia
Public title
Investigating the effect of intensive manual therapy on the voice quality of patients with dysphonia caused by muscle tension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Do not have polyp, nodule, spasmodic dysphonia, chronic fatigue syndrome, and history of thyroid surgery (determined by laryngoscopy) and have type 1 MTD. Patients should not have any surgery history, temporomandibular joint problems, short neck, neurological and behavioral problems. Dysphonia score of people should be moderate to severe, and this score will be determined based on palpation test and extralaryngeal muscle tension. Patients should not use steroids, alcohol, or smoke for a long period of time. Patients should not have lung disease, flu, hearing disorder, upper respiratory tract infection, nervous disorder and hypothyroidism.
Exclusion criteria:
People do not want to continue cooperation until the end of the study. Do not have access to people to provide treatment every day.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 8
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The study design is single subject and assessment-intervention-evaluation (ABA).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St. in front of Hamadan University of Medical Sciences Mardom Park
City
HAMADAN
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.UMSHA.REC.1402.225

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
fundamental frequency
Timepoint
Three evaluation points before the intervention and in the basic evaluation phase, six evaluation points during the intervention and three evaluation points during the follow-up and after the intervention.
Method of measurement
PRAAT software

Secondary outcomes

1

Description
voice quality
Timepoint
Three evaluation points before the intervention and in the basic evaluation phase, six evaluation points during the intervention and three evaluation points during the follow-up and after the intervention.
Method of measurement
PRAAT software

Intervention groups

1

Description
Intervention group: dysphonic people / In the first phase, no intervention is provided and the individual's speech sample is recorded for six days and every other day at three points for perceptual and acoustic evaluation. In the intervention phase, which includes 12 sound therapy sessions, MCT and LMT treatments will be provided. During the intervention, data collection is done at 6 points by perceptual and acoustic evaluation. During the follow-up phase, the basic evaluation process will be repeated.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Speech Therapy Clinics in Hamadan University of medical science M
Full name of responsible person
Kowsar Baghban
Street address
Shahid fahmide Blv
City
hamadan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3838 1571
Email
baghban.kowsar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokoohi
Street address
5th floor, headquarters of the University of Medical Sciences, Shahid Fahmideh St., Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
webda@umsha.ac.ir
Grant name
Grant code / Reference number
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
Kowsar Baghban
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Speech therapy department, Faculty of Rehabilitation, University of Medical Sciences, Shahid Fahmideh St., Hamadan
City
hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1571
Email
baghban.kowsar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Kowsar Baghban
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Speech therapy department, Faculty of Rehabilitation, University of Medical Sciences, Shahid Fahmideh St., Hamadan
City
hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1571
Email
baghban.kowsar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyede Saghar Hashemnia
Position
Master of Science student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Speech therapy department, Faculty of Rehabilitation, University of Medical Sciences, Shahid Fahmideh St., Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1572
Email
hashemniasaghar1401@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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