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IRCT20210131050187N1 IRCT 2021-06-15 Research Deputy of University of Social welfare and Rehabilitation Sciences Multidimensional evaluation of the effectiveness of Early Voice Therapy Protocol on the voice of patients with Early Laryngeal Carcinoma after Transoral Laser Microsurgery (TLM) Evaluation of the effectiveness of Early Voice Therapy Protocol on Vocal Function, Self- Assessment of Vocal Function and Quality of Life for Patients with Early Laryngeal Carcinoma after Transoral Laser Microsurgery (TLM) 2021-06-22 anticipated 24 Complete https://irct.ir/trial/56300 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the first step to create a randomization, individuals are first placed in one of the treatment or control groups using the block randomization method performed by someone other than the researcher; The block randomization method in this research is performed in such a way that first we assign code to all eligible people to enter the study and in the next step, using the table of random numbers to determine the direction to move on this table. For treatment and control groups, we consider two blocks of equal size and 12 (including 12 people in the intervention group and 12 people in the control group) and then randomly close their eyes with a finger on a point. We place the rows and columns of the table at the intersection and numbers that are equal to or less than the sample size are seen and random sequences are created for these blocks. In the next step, to execute the random sequence generated on the subjects, we will use the random allocation concealment method so that the assigned group is not known before the individual is assigned. In this study, using non-transparent containers sealed with the same weight and shape of each random sequences created on a registration card and cards are inserted into the cans respectively. In order to maintain a random sequence, the numbering on the outer surface of the boxes is done in the same way.Eventually, the lids of the cans are sealed, and according to the order in which eligible people enter the study, one of the cans is opened in order, and the assigned group of the participant is revealed, Blinding description: To blind the research, a speech therapist from outside the current research project with at least 5 years of clinical / research experience and trained to work with laboratory programs and devices to assess treatment outcomes and collect data on variables in the three domains of vocal function, Self-assessment of vocal function and quality of life is used. In the present study, data analysis is performed by a person other than the main researcher and analyzes the study data. Also, the participants of the two groups do not know which group they are in. In other words, the subjects will be given only the necessary information about the general objectives and conditions of the study, and all participants were unaware that they were in the treatment or control group, and at the start of the project, only in order and in the form of Individuals receive a attendance schedule from the researcher. It should be noted that participants do not communicate with each other and their presence for evaluation and treatment is done individually and separately from each other. N/A Laryngeal Carcinoma. Intervention 1: Intervention group: Patients in the Intervention group, received early voice therapy intervention consisting of Symptomatic Voice Therapy (including chewing, yawn - sigh, Lip Roll and tongue Trill, pitch change, vocal focus change, pitch change, chin chirping, and breathing exercises) with training voice hygiene twice a week, for a total of 10 sessions of 30 minutes for 5 weeks (a total of 300 minutes / 5 hours of voice therapy) and are re-evaluated after this process.The order and process of presenting the training in the treatment sessions is such that the therapist teaches voice hygiene tips at the beginning of the session and has an overview of the exercises of the previous session and the correctness of their implementation, then teaches the new method. In the first session, after providing voice hygiene recommendations, the therapist teaches loudness level and exercises on level 2 of change of loudness method during continuous speech and reading. In the second session, the therapist again provides voice hygiene recommendations and reviews the practice of the previous session, which included the technique of change of loudness, then teaches how to change the focus of voice. In the third session, the therapist first reviews the exercises of the previous sessions (including changing the loudness and changing the focus of the voice) and then teaches the breathing exercises and the pitch inflections method. At the beginning of the fourth session, the therapist reviews the exercises of the previous sessions (including the practice of pitch inflections and change of loudness methods) with the patient, and then deals with breathing exercises and chewing method. The fifth session begins with a review of the exercises of the previous sessions (including chewing and pitch inflections methods) and ends with breathing exercises and Yawn - Sigh training.At the beginning of the sixth session, the exercises of the previous sessions (including the methods of chewing and Yawn - Sigh) are reviewed, then breathing exercises and the Lip Roll and Tongue Trill are taught. In the seventh session, the exercises of the previous sessions (including Lip Roll, tongue Trill, Yawn - Sigh methods) are reviewed, followed by breathing exercises and training and practice of the Glottal Fry method.In the eighth session, the therapist first reviews the exercises of the previous sessions (including Glottal Fry and Yawn - Sigh methods), then practices breathing exercises and the method of Lip Roll and Tongue Trill with the patient. In the ninth session, the previous exercises were reviewed in such a way that the method of pitch inflections with the change of loudness and the method of chewing (at the level of words and sentences) with the Glottal Fry and the method of Yawn - Sigh with the production of the word were practiced and repeated with the patient. In the tenth session, Lip Roll and Tongue Trill with Pitch Inflections methods, chewing with Yawn - Sigh methods, the Glottal Fry with a change of loudness is practiced and repeated with the patient. It should be noted that treatment sessions are held individually. The researcher will also make four 15-minute phone calls with the participants of the treatment group one month after the end of the treatment with intervals of 7 days to follow up and inform about their general condition, and then the individuals will be re-evaluated at the end of this course. Intervention 2: Control group: The therapist provides the patient with the necessary training in a number of cases: including awareness of behaviors related to the use of voice, such as talking for long periods of time, laughing and crying out loud, clearing the throat as usual, screaming and shouting; Adjusting environmental conditions such as avoiding talking and being in crowded, dry environments containing pollutants and smoke; Improving diet and lifestyle: Avoid high-calorie and fatty foods, caffeine, tobacco, alcohol and adequate rest and sleep. For voice hygiene training twice a week for a total of ten 30-minute sessions for 5 weeks (300 minutes). The researcher will also make four 15-minute phone calls at 7-day intervals with participants of both treatment and control groups to follow up and be informed of their general condition, and then individuals. They will be re-evaluated at the end of this course. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Akbar Darouei
Kodakyar Ave., Daneshjo Blvd., Evin, University of Social Welfare and Rehabilitation Sciences
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0043 adarouie@hotmail.com University of social welfare and rehabilitation sciences scientific Akbar Darouei
Kodakyar Ave., Daneshjo Blvd., Evin, University of Social Welfare and Rehabilitation Sciences
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0083 adarouie@hotmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Willingness to participate in research Age range 18 to 65 years Infection with unilateral or bilateral malignant tumors of the Glottis Area Being at stage zero, 1 or 2 tumor growth No metastasis to lymph nodes and other parts of the body Not receiving other oncological treatments (such as radiation, hormones and chemotherapy) before or at the same time as the research period Do not participate in other courses of voice therapy after oncology treatment to improve voice disorder A maximum of 3 days have elapsed since the completion of the laser surgery Ability to read and write No cognitive problems No diabetes No drug use Do not use alcohol 18 years 65 years Both Advanced laryngeal cancer Receiving parallel and simultaneous other oncological treatments such as radiotherapy and chemotherapy The presence of malignant cells in other parts of the larynx and body except the pelvis C32.0 Malignant neoplasm of glottis Rehabilitation Rehabilitation Intervention group: Patients in the Intervention group, received early voice therapy intervention consisting of Symptomatic Voice Therapy (including chewing, yawn - sigh, Lip Roll and tongue Trill, pitch change, vocal focus change, pitch change, chin chirping, and breathing exercises) with training voice hygiene twice a week, for a total of 10 sessions of 30 minutes for 5 weeks (a total of 300 minutes / 5 hours of voice therapy) and are re-evaluated after this process.The order and process of presenting the training in the treatment sessions is such that the therapist teaches voice hygiene tips at the beginning of the session and has an overview of the exercises of the previous session and the correctness of their implementation, then teaches the new method. In the first session, after providing voice hygiene recommendations, the therapist teaches loudness level and exercises on level 2 of change of loudness method during continuous speech and reading. In the second session, the therapist again provides voice hygiene recommendations and reviews the practice of the previous session, which included the technique of change of loudness, then teaches how to change the focus of voice. In the third session, the therapist first reviews the exercises of the previous sessions (including changing the loudness and changing the focus of the voice) and then teaches the breathing exercises and the pitch inflections method. At the beginning of the fourth session, the therapist reviews the exercises of the previous sessions (including the practice of pitch inflections and change of loudness methods) with the patient, and then deals with breathing exercises and chewing method. The fifth session begins with a review of the exercises of the previous sessions (including chewing and pitch inflections methods) and ends with breathing exercises and Yawn - Sigh training.At the beginning of the sixth session, the exercises of the previous sessions (including the methods of chewing and Yawn - Sigh) are reviewed, then breathing exercises and the Lip Roll and Tongue Trill are taught. In the seventh session, the exercises of the previous sessions (including Lip Roll, tongue Trill, Yawn - Sigh methods) are reviewed, followed by breathing exercises and training and practice of the Glottal Fry method.In the eighth session, the therapist first reviews the exercises of the previous sessions (including Glottal Fry and Yawn - Sigh methods), then practices breathing exercises and the method of Lip Roll and Tongue Trill with the patient. In the ninth session, the previous exercises were reviewed in such a way that the method of pitch inflections with the change of loudness and the method of chewing (at the level of words and sentences) with the Glottal Fry and the method of Yawn - Sigh with the production of the word were practiced and repeated with the patient. In the tenth session, Lip Roll and Tongue Trill with Pitch Inflections methods, chewing with Yawn - Sigh methods, the Glottal Fry with a change of loudness is practiced and repeated with the patient. It should be noted that treatment sessions are held individually. The researcher will also make four 15-minute phone calls with the participants of the treatment group one month after the end of the treatment with intervals of 7 days to follow up and inform about their general condition, and then the individuals will be re-evaluated at the end of this course. Control group: The therapist provides the patient with the necessary training in a number of cases: including awareness of behaviors related to the use of voice, such as talking for long periods of time, laughing and crying out loud, clearing the throat as usual, screaming and shouting; Adjusting environmental conditions such as avoiding talking and being in crowded, dry environments containing pollutants and smoke; Improving diet and lifestyle: Avoid high-calorie and fatty foods, caffeine, tobacco, alcohol and adequate rest and sleep. For voice hygiene training twice a week for a total of ten 30-minute sessions for 5 weeks (300 minutes). The researcher will also make four 15-minute phone calls at 7-day intervals with participants of both treatment and control groups to follow up and be informed of their general condition, and then individuals. They will be re-evaluated at the end of this course. Jitter (Frequency Perturbation). Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Acoustic analysis of voice signal with Multidimensional Voice Program software. Shimmer (Amplitude Perturbation). Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Acoustic analysis of Voice signal with Multidimensional Voice Program software. Noise to Harmonic Ratio. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Acoustic analysis of Voice signal with Multidimensional Voice Program software. Relative Average Perturbation. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Acoustic analysis of Voice signal with Multidimensional Voice Program software. Amplitude Perturbation Quotient. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Acoustic analysis of Voice signal with Multidimensional Voice Program software. Voice Turbulence Index. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Acoustic analysis of Voice signal with Multidimensional Voice Program software. Soft Phonation Index. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Acoustic analysis of Voice signal with Multidimensional Voice Program software. Degree of Voicelessness. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Acoustic analysis of Voice signal with Multidimensional Voice Program software. Cepstral Peak Prominence. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Acoustic analysis of Voice signal with Praat software. Smoothed Cepstral Peak Prominence. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Acoustic analysis of Voice signal with Praat software. Maximum Phonation Time. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Calculate the duration of sustain phonation of vowel /a/ with Stopwatch Application. Vital Capacity. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Spirometry. Phonation Quotient. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: The score obtained by dividing the Vital capacity parameters by the Maximum Phonation Time. Dysphonia Severity Index. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: The weighted score of the parameters of Maximum Phonation Time, highest Frequency, lowest Intensity and Jitter of voice signal. Vocal Folds edge. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: View and evaluate videolaryngoscopic images. Glottic Closure Pattern. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: View and evaluate videolaryngoscopic images. Amplitude of Vibration. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: View and evaluate videolaryngoscopic images. Phase Symmetry. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: View and evaluate videolaryngoscopic images. Muscle Tension Patterns. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: View and evaluate videolaryngoscopic images. Total Severity of perceptual voice disorder. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: score in the Persian Consensus Auditory Perceptual Evaluation of Voice test. Self assessment of Vocal Function. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Voice Handicap Index 30 Score. Quality of Life. Timepoint: At the beginning of the intervention, the end of the intervention, one month after the end of the intervention. Method of measurement: Iranian Voice Quality of Life. Research Deputy of University of Social welfare and Rehabilitation Sciences Approved 2021-05-12 Ethics Committee of the University of Social Welfare and Rehabilitation Sciences Kodakyar Ave., Daneshjo Blvd., Evin, University of Social Welfare and Rehabilitation Sciences Tehran Tehran Iran (Islamic Republic of)