Protocol summary
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Study aim
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survey on the effect of vocal function exercises on the vocal fatigue index mean score in the bank workers after 14 days of exercises
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Design
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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)
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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1. vocal fatigue index
2. voice handicap index
General information
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Reason for update
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spelling mistake in the English title
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Acronym
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Vocal Function Exercises (VFEs) + Vocal Fatigue (VF)
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IRCT registration information
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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
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Registration date
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2022-02-17, 1400/11/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-04-03, 1401/01/14
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Expected recruitment end date
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2022-07-05, 1401/04/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of Vocal Function Exercises on vocal fatigue in professional voice users
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Public title
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Investigation about the effect of VFEs on VF
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
42
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-06-08, 1400/03/18
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Ethics committee reference number
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IR.IUMS.REC.1400.225
Health conditions studied
1
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Description of health condition studied
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voice disorders
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ICD-10 code
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R49
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ICD-10 code description
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Voice and resonance disorders
2
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Description of health condition studied
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Vocal fatigue
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ICD-10 code
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R49.0
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ICD-10 code description
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Dysphonia
Primary outcomes
1
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Description
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scores in the three sections of the vocal fatigue index (VFI)
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Timepoint
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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)
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Method of measurement
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Persian version of Vocal Fatigue Index
Secondary outcomes
1
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Description
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Total score of the voice handicap index (VHI)
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Timepoint
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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)
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Method of measurement
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Persian version of Voice Handicap Index
Intervention groups
1
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Description
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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).
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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
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When the data will become available and for how long
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A year after publishing the paper of project
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To whom data/document is available
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researcher in the Medical universities in Iran
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Under which criteria data/document could be used
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1. the research that will not approve by the applicant university
2. use of data for other porpuses
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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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.
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Comments
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This is a university project. So maybe the requests will not be accepted by our university system ultimately.