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)

evaluate the effectiveness of early voice therapy on vocal function, self-assessment of vocal function and quality of life in patients with Early laryngeal carcinoma after laser surgery

A randomized controlled clinical trial on 48 patients with early laryngeal cancer undergoing laser surgery with inclusion criteria and referred to the speech rehabilitation ward of Amira'lam Hospital in Tehran using available sampling method. Assignment to the intervention and control groups is done by Blocked randomization method.

This study is performed in Amira'lam Hospital of Tehran.The study is also conducted as a single blind. patients in both groups do not know which group they are in.

Inclusion criteria: infection with unilateral or bilateral malignant tumors of the Glottis area, being in stage zero,1 or 2 tumor growth, not receiving other oncological treatments (such as radiation, hormones and chemotherapy) before or at the same time with the research period, maximum 3 days Completion of laser surgery; Exclusion criteria: advanced laryngeal cancer, diagnosis of malignancy in other parts of the larynx and body except the Glottis.

Participants in the intervention group underwent voice rehabilitation with a symptomatic approach (consisting of change of loudness, focus, pitch inflections, chewing, Yawn - Sigh, Lip Roll and Tongue Trill, Glottal Fry and breathing exercises) with voice hygiene recommendations in ten 30-minute sessions is given twice a week (a total of 300 minutes / 5 hours), while the control group will be presented in parallel, during which time only voice hygiene recommendations will be provided.

Values of acoustic analysis, aerodynamics and auditory parameters; ranking of videolaryngoscopic image parameters; self-assessment score of vocal function; quality of life score

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.

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.