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IRCT20220116053728N1 IRCT 2022-02-17 Iran University of Medical Sciences Investigation about the effect of VFEs on VF Vocal Function Exercises (VFEs) + Vocal Fatigue (VF) Investigating the effect of Vocal Function Exercises on vocal fatigue in professional voice users 2022-04-03 anticipated 42 Complete https://irct.ir/trial/61333 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Condition 1: voice disorders. Condition 2: Vocal fatigue. Intervention 1: 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). Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: A year after publishing the paper of project To whom: researcher in the Medical universities in Iran Conditions: 1. the research that will not approve by the applicant university 2. use of data for other porpuses Where to obtain: 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 How to obtain: 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.
public Mohammad Sedigh Mahmoudzadeh
speech therapy department, rehabilitation school, MadadKaran street, ShahNazari street, Madar square, Mirdamad street
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 mmahmudzade.slps@gmail.com Iran University of Medical Sciences scientific Farhad TorabiNezhad
میرداماد- میدان مادر-خیابان شاه نظری- خیابان مددکاران-دانشکده علوم توانبخشی-گروه گفتار درمانی
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 torabinezhad.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 50 years Both 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. R49 R49.0 Voice and resonance disorders Dysphonia Treatment - Other Rehabilitation 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). 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. 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. 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. Iran University of Medical Sciences Approved 2021-06-08 Ethical committee of Iran university of medical sciences Iran University of medical sciences, Hemmat freeway, next to Milad tower Tehran Tehran Iran (Islamic Republic of)