the effect of tele-voice therapy in comparison with in-person treatment on the acoustic, perceptual and aerodynamic characteristics of voice in voice-actors.
The aim of this study was to investigate the changes in the perceptual, acoustic and aerodynamic characteristics of voice actors' voices after receiving face-to-face and remote voice therapy. By re-examining the variables in the follow-up period, the stability of treatment is also determined. Receiving voice therapy services will also indirectly improve the quality of life of voice actors.
Design
This study is a semi-experimental study that will be conducted in two groups of voice actors with voice complaints in person and remotely.
The sample of this study is 14 voice actors with voice complaints who are selected by the virtual snowball method and undergo 18 sessions of voice therapy (three sessions per week, each session 60 minutes).
Settings and conduct
Assessment for all participants and treatment for the in-site group will take place at the speech therapy clinic of Iran University of Medical Sciences. Voice therapy will include: breathing exercises, head and neck exercises, warming up and cooling down, and voice hygiene counseling.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The age range of 20 to 48 years.
at least 4 years of full-time voice acting experience.
at least one voice complaint.
no previous history of voice therapy.
no previous history of head and neck surgery.
enough vision to watch videos and make video calls.
no cold, flu, or airway infection during the sampling or two weeks before.
Exclusion criteria:
the reluctance of the participant to continue cooperation.
Failure to record a good sample for voice analysis.
Intervention groups
Two groups of seven voice actors with voice complaints that voice therapy interventions in one group will be performed directly and in the other group remotely.
the effect of tele-voice therapy in comparison with in-person treatment on the acoustic, perceptual and aerodynamic characteristics of voice in voice-actors.
Public title
telepractice versus in-person treatment of voice disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The participant is in the age range of 20 to 48 years.
The participant reports at least one voice complaint.
The participant has no previous history of voice therapy.
The participant does not have a history of head and neck surgery.
The participant has enough vision to watch videos and make video calls.
The participant did not have a cold, flu, or airway infection during the sampling or two weeks before.
The participant must have at least 4 years of full-time voice acting experience.
Exclusion criteria:
The reluctance of the participant to continue cooperation with the research group
Failure to record a good sample for voice analysis
Age
From 20 years old to 48 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
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
The Iran University of Medical Sciences Ethics Committee
Street address
Tehran Hemat Highway next to Milad Tower، 14535
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-09-12, 1400/06/21
Ethics committee reference number
IR.IUMS.REC.1400.533
Health conditions studied
1
Description of health condition studied
voice disorder
ICD-10 code
R49
ICD-10 code description
Voice and resonance disorders
Primary outcomes
1
Description
fundamental frequency
Timepoint
before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention
Method of measurement
praat software
2
Description
jitter
Timepoint
before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention
Method of measurement
praat software
3
Description
shimmer
Timepoint
before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention
Method of measurement
praat software
4
Description
harmonic to noise ratio
Timepoint
before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention
Method of measurement
praat software
5
Description
maximum phonation time
Timepoint
before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention
Method of measurement
Stopwatch
6
Description
S to Z ratio
Timepoint
before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention
Method of measurement
Stopwatch
7
Description
voice discomfort index
Timepoint
before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention
Method of measurement
questionnaire
8
Description
voice handicap index
Timepoint
before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention
Method of measurement
questionnaire
9
Description
The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Timepoint
before intervention / 6 weeks after the start of the intervention / 10 weeks after the start of the intervention
Method of measurement
persian version of cape-5
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: in-person. This group will undergo 18 one-hour treatment sessions. Treatment for this group will include: breathing exercises, head and neck exercises, warming up and cooling down, and voice hygiene counseling Which will be performed at the speech therapy clinic of Iran University of medical sciences.
Category
Rehabilitation
2
Description
Intervention group2: online. This group will undergo 18 one-hour treatment sessions. Treatment for this group will include: breathing exercises, head and neck exercises, warming up and cooling down, and voice hygiene counseling Which will be performed on Skype software.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of medical sciences
Full name of responsible person
Sadaf Salehi
Street address
Mirdamad blvd
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7159
Email
gooshmahiam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein keivani
Street address
Hemmat Highway /
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Sadaf Salehi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
No.46 Izadi street, Gisha, Tehran
City
Tehran
Province
Tehran
Postal code
1447833431
Phone
+98 930 890 4683
Fax
Email
gooshmahiam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Ghelichi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Mirdamad
City
Tehran
Province
Tehran
Postal code
14477833431
Phone
+98 21 2222 2059
Fax
Email
lghelichi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sadaf Salehi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
No.46 Izadi street, Gisha, Tehran
City
Tehran
Province
Tehran
Postal code
1447833431
Phone
+98 21 8670 5503
Fax
Email
gooshmahiam@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Some of the participants' personal data related to the main outcome will be shared with the researchers in the form of articles and dissertations.
When the data will become available and for how long
Access after publishing the results in the form of an article.
To whom data/document is available
voice disorders researchers
Under which criteria data/document could be used
For use in similar research
From where data/document is obtainable
Sadaf Salehi
Email: gooshmahiam@gmail.com
What processes are involved for a request to access data/document
Request to be approved by the scientific supervisor of this research - Dr. Leila Ghelichi