]>
IRCT20230307057649N1 IRCT 2023-09-05 Tehran University of Medical Sciences Comparison of the effectiveness of different semi-occluded vocal tract exercises in patients with primary Muscle Tension Dysphonia Comparison of the effectiveness of tongue trill, lip trill, straw phonation, and water resistance therapy exercises in patients with primary Muscle Tension Dysphonia 2023-09-19 anticipated 30 Complete https://irct.ir/trial/69336 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The studied samples will be randomly divided into five groups to receive one of the five treatments of tongue trill, lip trill, straw phonation, water resistance therapy, and vocal hygiene. Using the rule of random allocation in creating a random sequence and observing the concealment of random allocation is done by Permuted block randomization. For this purpose, 30 people in the sample size of this study are considered as six blocks of five. Each of these six blocks contains five 5 codes of the first to fifth methods. Each block is placed in a separate box containing opaque envelopes containing the codes of five treatment methods, and the blocks are used one after the other for the lottery. Patients are asked to draw one of the envelopes, take it out and open it and present it to the researcher to be placed in the relevant group, Blinding description: In this research, pre-and post-treatment assessments are performed by a speech therapist, and the presentation of therapeutic exercises is by another speech therapist who is the primary researcher of this study. Therefore, the outcome assessor will be blinded to the treatment group allocation, and the principal investigator will be blinded to the assessment results. From the beginning, we will explain to the participants that in this study we intend to compare the effectiveness of several voice therapy methods. We explain to them that these treatment methods have similar goals and are provided to facilitate voice production and solve their voice problems. Next, we explain that the effectiveness of these treatment methods has already been proven and we explain to them about the mechanism of these exercises that this mechanism is implemented using different voice exercises. They are supposed to be randomly placed in one of these treatment groups. Participants with knowledge of the above topics will enter the study if they declare their readiness to participate in this research through the informed consent form. Before the start of the assessment and treatment, the necessary arrangements are made so that the participants do not see each other during the entire period of treatment and assessment. Due to the fact that all participants are assessed and treated individually and will not see other patients, they will not be informed about the allocation of treatment groups. N/A Primary muscle tension dysphonia. Intervention 1: First intervention group: The first intervention group will receive voiced tongue trill exercise during four 45-minute sessions over two weeks. Intervention 2: Second intervention group: The second intervention group will receive voiced lip trill exercise during four 45-minute sessions during two weeks. Intervention 3: Third intervention group: The third intervention group will receive straw phonation exercise during four 45-minute sessions during two weeks. Intervention 4: Fourth intervention group: The fourth intervention group will receive water resistance therapy during four 45-minute sessions during two weeks. Intervention 5: Control group: The control group will receive the vocal hygiene program in four 45-minute sessions over two weeks. 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 I need to consult with my supervisor before making a decision
public Roonak Aziz
Western 4th floor.,No.17, western six Alley., North Varzi Ave., West Ferdos Blvd
Tehran Iran (Islamic Republic of) 1483793818 +98 21 4412 8013 r-aziz@razi.tums.ac.ir Tehran University of Medical Sciences scientific Roonak Aziz
No.17, West Sixth Alley., Varzi North Ave., West Ferdous Blvd
Tehran Iran (Islamic Republic of) 1483793818 +98 21 4412 8013 r-aziz@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Be female The age range of 20-50 years Announce their informed consent to participate in the study Based on the consensus opinion of an otolaryngologist and an experienced speech therapist in the field of voice disorders and based on the results of voice history taking, larynx observation, palpation examination, auditory-perceptual assessment of voice and self-assessment, receive the diagnosis of primary muscle tension disorder 20 years 55 years Female Patients who smoke and drink alcohol Patients suffering from hearing loss, hormonal and neurological diseases Patients who have a history of laryngeal surgery and laryngeal trauma Patients who have gone through menopause Patients who receive another voice therapy program at the same time as this study Patients who are pregnant R49.0 Dysphonia Rehabilitation Rehabilitation Rehabilitation Rehabilitation Lifestyle First intervention group: The first intervention group will receive voiced tongue trill exercise during four 45-minute sessions over two weeks Second intervention group: The second intervention group will receive voiced lip trill exercise during four 45-minute sessions during two weeks Third intervention group: The third intervention group will receive straw phonation exercise during four 45-minute sessions during two weeks Fourth intervention group: The fourth intervention group will receive water resistance therapy during four 45-minute sessions during two weeks Control group: The control group will receive the vocal hygiene program in four 45-minute sessions over two weeks Maximum phonation time. Timepoint: Before the start of the intervention and immediately after the completion of four treatment sessions. Method of measurement: Praat Software. First Formant. Timepoint: Before the start of the intervention and immediately after the completion of four treatment sessions. Method of measurement: Praat Software. The difference between the first formant and the fundamental frequency. Timepoint: Before the start of the intervention and immediately after the completion of four treatment sessions. Method of measurement: Praat Software. Cepstral peak prominence. Timepoint: Before the start of the intervention and immediately after the completion of four treatment sessions. Method of measurement: Praat software. Cepstral peak prominence-smoothed. Timepoint: Before the start of the intervention and immediately after the completion of four treatment sessions. Method of measurement: Praat software. Overall Severity of Dysphonia. Timepoint: Before the start of the intervention and immediately after the completion of four treatment sessions. Method of measurement: Auditory-perceptual evaluation of voice, scale. Vocal tract discomfort scale. Timepoint: Before the start of the intervention and immediately after the completion of four treatment sessions. Method of measurement: Self-assessment, The Persian version of the Vocal Tract Discomfort scale. Voice Handicap Index. Timepoint: Before the start of the intervention and immediately after the completion of four treatment sessions. Method of measurement: Self-assessment, The Persian version of the VHI questionnaire. Tehran University of Medical Sciences Approved 2023-04-15 School of Nursing and Midwifery and School of Rehabilitation-Tehran University of Medical Sciences Department of Speech Therapy, School of Rehabilitation, Pich Shemiran, Enghelab St., Tehran Tehran Tehran Iran (Islamic Republic of)