Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
empty
spelling mistake in the English title
spelling mistake in the English title
empty
اشتباه نوشتاری در عنوان انگلیسی
اشتباه نوشتاری در عنوان انگلیسی
ُُُُُُُُُُُُُُُُُُُُُُُُinvestegating the effect of Vocal Function Exercises on the vocal fatigue in professional voice users
Investigating the effect of Vocal Function Exercises on vocal fatigue in professional voice users
ُُُُُُُُُُُُُُُُُُُُُُُُinvestegatingInvestigating the effect of Vocal Function Exercises on the vocal fatigue in professional voice users
Protocol summary
Study aim
survey on the effect of vocal function exercises on the vocal fatigue index mean score in the bank workers after 14 days of exercises
Design
the two-staged parallel randomized trial (screening and prevalence estimation + intervention) with the control group, double-blind (participants and data analyzers), the four-levels blocked randomization (physical cards), sample size 42 (same distribution between control/intervention groups), and gender as the moderator variable, and simple random sampling (lottery)
Settings and conduct
1. questionnaire distribution: physical/electronic (Google form)
2. training of participants for the intervention stage: in-presence (in the bank branches) or online (WhatsApp)
3. double-blind: participants by uniforming and data analyzers by coding the data
Participants/Inclusion and exclusion criteria
1. age range: 18-50
2. at least three working days
3. at least 1.5 hours of daily speaking
4. maximum use of maternal language in a working position
5. maximum use of facial mask in a working position
Intervention groups
1. Vocal Function Exercises (VFEs): The VFEs will be practiced daily for two weeks, twice a day (day and night). The protocol parts are 1. The maximum Phonation Time (MPT) of vowel /i/ 2/3. Upward and downward gliding of vocal pitch, respectively; 4. The MPT at the five pre-determined musical notes (depending on the Gender class).
2. Control group: gathering the pre-term data; request to wait for two weeks; gathering post-term data; after that, training the VFEs. They aren't informed to be in the control group.
Main outcome variables
1. vocal fatigue index
2. voice handicap index
General information
Reason for update
spelling mistake in the English title
Acronym
Vocal Function Exercises (VFEs) + Vocal Fatigue (VF)
IRCT registration information
IRCT registration number:IRCT20220116053728N1
Registration date:2022-02-17, 1400/11/28
Registration timing:prospective
Last update:2022-02-20, 1400/12/01
Update count:1
Registration date
2022-02-17, 1400/11/28
Registrant information
Name
Mohammad Sedigh Mahmoudzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
mmahmudzade.slps@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-07-05, 1401/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Vocal Function Exercises on vocal fatigue in professional voice users
Public title
Investigation about the effect of VFEs on VF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The participant must work at least three days a week that directly contacts customers.
The participant must have at least 1.5 hours of speaking on each working day.
The participant should often use their maternal language to communicate with customers.
The participant often uses a mask in the working environment.
Exclusion criteria:
The applicant has a history of neurological, respiratory, head and neck, pharyngeal/laryngeal, allergies, asthma, reflux, and/or hearing system diseases or surgeries.
The applicant have a vocal training in the last six months ago.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
In the intervention stage of the study, participants will allocate to the control or intervention group. According to previous studies, gender is considered as the intervening variable. we will use four level blocking method to guarantee the analogous and simultaneous distribution of participants between groups. In this way, all possible allocation groups (six) are determined and any specific groups will pack in the paper pocket that allows selective visualization of events in order. any gender groups deliver a category of allocation. A group of six-allocated groups six groups will select in the random method (random withdrawals of cards by another person). The next four participants will allocate in the control/intervention group that two participants will consider as control and two others will consider as the intervention but the order of this allocation remains unclear. This procedure will follow to complete the sample size of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants who will allocate to the intervention group will train to practice the VFEs exercises. Researchers inform them that their actual intervention will start after these two weeks of warm-up practices. Also, We will ask control group participants to wait until the next two weeks that their training start. Both groups will give an approved voice exercise after gathering post-term data. The data will be coded then analyzed by an unaware statistician.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Iran university of medical sciences
Street address
Iran University of medical sciences, Hemmat freeway, next to Milad tower
City
Tehran
Province
Tehran
Postal code
14496-14535
Approval date
2021-06-08, 1400/03/18
Ethics committee reference number
IR.IUMS.REC.1400.225
Health conditions studied
1
Description of health condition studied
voice disorders
ICD-10 code
R49
ICD-10 code description
Voice and resonance disorders
2
Description of health condition studied
Vocal fatigue
ICD-10 code
R49.0
ICD-10 code description
Dysphonia
Primary outcomes
1
Description
scores in the three sections of the vocal fatigue index (VFI)
Timepoint
On the day of training and one day before the start of training (in the intervention group) or one day before the start of the 14 days in the control group (pre-term data); One day after completing the 14-day training period (in the intervention group) or the waiting period in the control group (post-term data)
Method of measurement
Persian version of Vocal Fatigue Index
Secondary outcomes
1
Description
Total score of the voice handicap index (VHI)
Timepoint
On the day of training and one day before the start of training (in the intervention group) or one day before the start of the 14 days in the control group (pre-term data); One day after completing the 14-day training period (in the intervention group) or the waiting period in the control group (post-term data)
Method of measurement
Persian version of Voice Handicap Index
Intervention groups
1
Description
Intervention group: Participants in the intervention group will do VFEs practices. The VFEs is an organized vocal practice, structured as vocal pitch-based practice and designed in four sections. Section one is the vocal warm-up that is designed to engage the laryngeal system. Practically, this section is the maximum prolongation of the /i/ vowel on the musical note (F) above the middle (C) for females (349.23Hz), and (F) below the middle (C) for males. The goal is to sustain the /i/ for as long as you can sustain as /s/. The second section is the stretching that is designed to stretch vocal folds. The goal is that participants can smoothly glide from lowest notes to highest notes on the word "knoll" (sustain the "L"). The third section is the contraction that is designed to contract vocal folds. The goal is that persons can smoothly glide from highest notes to lowest notes on the word "knoll" (sustain the "L"). The fourth section is the low impact adductory power. In this section, participants sustain the musical notes (C-D-E-F-G) for as long as possible on the word "old" without the "d" (again, sustaining the "L" sound). using middle C for females, and an octave below middle C for males. in the last three sections, the goal is to produce the glide without voice breaks. The notes may be modified up or down to fit individual needs, but seldom by more than two notes in either direction. These participants will practice the VFEs for two weeks. According to the VFEs protocols, participants will do exercises every day. The vocal practices will execute two times daily, preferably morning and evening. In addition, The sounds that will be used in this exercise are in the Persian language space (dialectical variation).
Category
Treatment - Other
2
Description
Control group: The participants who are allocated in the control group were asked to wait for the next two weeks without being informed that they are in the control group. The VFEs exercises will teach to them after gathering post-term data.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
many branches of Melli Bank in scattered cities of Iran
Full name of responsible person
Mohammad Sedigh MahmouZadeh
Street address
upper floor of Shahid Fahmideh Branch, No. 296, Ostad Motahhari St
City
Tehran
Province
Tehran
Postal code
1588644111
Phone
+98 21 8830 4010
Fax
+98 21 8830 3616
Email
Training@Bmi.Ir
Web page address
https://amoozesh.bmi.ir/contactus.aspx?smnuid=31
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hoseyn Keyvani
Street address
Iran University of medical sciences, Hemmat freeway, next to Milad tower
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 2222 8051
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
1. Personal Information: gender; age
2. Medical History Information: Existence of any diseases listed
3. Lifestyle Information: Smoking and alcohol consumption (yes or not)
4. VHI and VFI scores: Total score of VHI, and scores of three sections of VFI
When the data will become available and for how long
A year after publishing the paper of project
To whom data/document is available
researcher in the Medical universities in Iran
Under which criteria data/document could be used
1. the research that will not approve by the applicant university
2. use of data for other porpuses
From where data/document is obtainable
1. Information will be given in SPSS or EXEL file format.
2. Name: Mohammad Sedigh Mahmoudzadeh
3. address: speech therapy department, rehabilitation school, MadadKaran street, ShahNazari street, Madar Square, Mirdamad street
4. phone number: 0098 9186476306
E-mail: mmahmudzade.slps@gmail.com
What processes are involved for a request to access data/document
The applicant must provide an official letter from his / her university. In this letter, they must clearly state the items they intend to use. The person must also commit to no other use.
Comments
This is a university project. So maybe the requests will not be accepted by our university system ultimately.