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Comparison of the effectiveness of face-to-face voice therapy and Telepractice in patients with Muscle Tension Dysphonia

Protocol summary

Study aim
compare the effectiveness of face-to-face and remote voice therapy in patients with dysphonia caused by muscle tension
Design
Clinical trial with control group,with parallel groups,double-blind,simple randomized,phase1 on 46patients.Randomization is done in a simple way through lottery.
Settings and conduct
The study is conducted on 46 MTD patients referred to otolaryngology clinics of Jundishapur University of Medical Sciences in Ahvaz.vocal facilitation techniques, including chewing, breathing exercises,yawn-sigh,open mouth, glottal fry,and confidential speech will be used for the first treatment group.In the online treatment, the those techniques will be presented to the clients in the same way,all the clients of the second group will receive all 6 techniques.voice facilitation techniques and voice health consultations are provided through video calls on the ZOOM platform in 18 sessions for six weeks.
Participants/Inclusion and exclusion criteria
Not having neurological diseases,voice disorders and lung problems.Not having any surgery that leads to hoarseness or bad effects on the voice.Not suffering from thyroid disease and hormonal problems.not taking drugs that affect voice.not suffering from colds and allergic and respiratory diseases for the past two months.no history of receiving voice therapy services.
Intervention groups
six vocal facilitation techniques, including chewing, breathing exercises,yawn-sigh,open mouth,glottal fry,and confidential speech will be used for the first treatment group.In the online treatment,the those techniques will be presented to the clients in the same way.voice facilitation techniques and voice health consultations are provided through video calls on the ZOOM platform in 18 sessions for six weeks.
Main outcome variables
dysphonia severity,voice handicape,vocal tract discomfort,vocal fatigue,auditory-perceptual assessment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230306057636N1
Registration date: 2023-04-14, 1402/01/25
Registration timing: registered_while_recruiting

Last update: 2023-04-14, 1402/01/25
Update count: 0
Registration date
2023-04-14, 1402/01/25
Registrant information
Name
Zahra Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 149 5644
Email address
z.sharifi21377@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-05-10, 1402/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of face-to-face voice therapy and Telepractice in patients with Muscle Tension Dysphonia
Public title
Comparison of the effectiveness of face-to-face voice therapy and Telepractice in patients with Muscle Tension Dysphonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to read and write Monolingual and Farsi-speaking patients Clients with dysphonia caused by muscle tension who have been diagnosed by an otolaryngologist and evaluated using video stroboscopy by a professional speech therapist with more than 15 years of experience.
Exclusion criteria:
record of receiving sound therapy services suffering from colds and allergic and respiratory diseases for the past two months (question from the patient) taking drugs affecting the voice having auditory system disease having thyroid disease and hormonal problems performing any surgery that leads to hoarseness or bad effects on the voice and these effects continue
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done in the form of a lottery, so that the name of each participant is written on the same size and similar papers. The names are placed in a container. After that, the names are placed in two groups in order of coming out. One person enters the intervention group and one person enters the control group (individuals receive remote treatment and couples receive face-to-face treatment) respectively. Randomization is done by a person who is not involved in the research process.
Blinding (investigator's opinion)
Double blinded
Blinding description
After providing the treatments, a speech therapist (separate from the therapist who provided the treatment) will evaluate the results without knowing the grouping of the clients. The researcher examines and reports the results without knowing whether each data group is related to the control group or the intervention. The data analyzer analyzes the Spss file and does not meet the participants.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Ahvaz - Boulevard of Medical Sciences - Jundishapur Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-03-04, 1401/12/13
Ethics committee reference number
IR.AJUMS.REC.1401.573

Health conditions studied

1

Description of health condition studied
Muscle Tension Dysphonia(MTD)
ICD-10 code
R49.8
ICD-10 code description
Other voice and resonance disorders

Primary outcomes

1

Description
The total score of the Dysphonia Severity Index (DSI)
Timepoint
Measuring the total score of dysphonia severity index before treatment and one month later.
Method of measurement
Dysphonia Severity Index

2

Description
The total score of the Voice Handicap Index(VHI)
Timepoint
Measuring the total score of Voice Handicap index before treatment and one month later.
Method of measurement
Voice handicap index questionnaire

3

Description
The total score of the Vocal Tract Discomfort index(VTD)
Timepoint
Measuring the total score of Vocal Tract Discomfort index before treatment and one month later.
Method of measurement
Vocal Tract Discomfort index questionnaire

4

Description
Vocal Fatigue Index (VFI) first part
Timepoint
Measuring the total score of Vocal Tract Discomfort index before treatment and one month later.
Method of measurement
Vocal fatigue index questionnaire

5

Description
Vocal Fatigue Index (VFI) second part
Timepoint
Measuring the total score of Vocal Tract Discomfort index before treatment and one month later.
Method of measurement
Vocal fatigue index questionnaire

6

Description
Vocal Fatigue Index (VFI) third part
Timepoint
Measuring the total score of Vocal Tract Discomfort index before treatment and one month later.
Method of measurement
Vocal fatigue index questionnaire

7

Description
Auditory-perceptual assessment (GRBAS)
Timepoint
Measuring the total score of Vocal Tract Discomfort index before treatment and one month later.
Method of measurement
GRBAS index, which examines 5 characteristics of the overall severity of the disorder, voice harshness, breathlessness, voice asthenia, and struggle.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 23 clients with muscle tension dysphonia, whose disorder was confirmed by an otolaryngologist and stroboscopic evaluations by a speech therapist, six voice facilitating techniques including exaggerated chewing, breathing exercises, sighing and yawning, open mouth, glottal fry and confidential speech in 18 half-hour sessions online and on the platform of ZOOM software.
Category
Rehabilitation

2

Description
Control group: 23 clients with muscle tension dysphonia, whose disorder was confirmed by an otolaryngologist and stroboscopic evaluations by a speech therapist, six voice facilitating techniques including exaggerated chewing, breathing exercises, sighing and yawning, open mouth, glottal fry and confidential speech in 18 half-hour face-to-face sessions
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Speech therapy clinics affiliated with Jundishapur University of Medical Sciences, Ahvaz
Full name of responsible person
Zahra Sharifi
Street address
Jundishapur University of Medical Sciences -Medical Sciences Blvd - Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 917 149 5644
Email
Z.sharifi21377@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Negin Moradi
Street address
Golestan area, Ostadan residential houses
City
Ahvaz
Province
Khouzestan
Postal code
91111111119
Phone
+98 916 631 2518
Email
neginmoradist@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Sharifi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
corner of Wahabi, 8th St. West - Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155845489
Phone
+98 917 149 5644
Email
z.sharifi21377@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Negin Moradi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Koi Ostadan - Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
9111111119
Phone
+98 916 506 0146
Email
neginmoradist@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Sharifi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Kianpars corner of Wahabi 8th street
City
Ahvaz
Province
Khouzestan
Postal code
6155845489
Phone
+98 917 149 5644
Email
z.sharifi21377@gmail.com

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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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