Investigation of the Perceptual and Acoustic Voice in Trans Man

Study Overview
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Brief Summary
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The aim of the study is to follow acoustic and perceptual voice changes in trans men during hormone therapy and to examine the relationship between psychosocial and vocal characteristics and testosterone measured in routine follow-up in accordance with international follow-up guidelines.

Detailed Description
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Trans men who have completed the evaluation and follow-up procedure and decided to use sex hormones will be included in the study. Participants will be followed for 6 months with three-month-follow ups. Acoustic and perceptual changes in voice will be monitored during hormone therapy. The relationship between testosterone and psychosocial and vocal characteristics will be examined. At the baseline of the study, participants will be evaluated with Videolaryngostroboscopy (VLS). As a result of VLS, perceptual and acoustic voice evaluation will be made to the participants who are determined to have healthy vocal folds. During routine psychiatric visits, participants will be asked to fill in self-report scales. Endocrinological routine evaluations will be applied to the participants and the data of these routine evaluations will be used in the study. All of these evaluations (perceptual and acoustic voice evaluation, endocrinological and psychiatric evaluations) will be repeated at the 3rd and 6th months of the hormone therapy, except for the VLS evaluation. IBM SPSS Statistics 26.0 and Microsoft Excel 365 programs will be used for statistical analysis. The number of participants to be included in the study was calculated using the G Power 3.1 program. In the analysis, the number of participants was determined as 28 (G power=0.80, α =0.05). The normal distribution of the data will be examined by visual and analytical methods (Shapiro-Wilk test, Kolmogorov-Smirnov test).The analysis of each variable measured at three time points will be evaluated using ANOVA if the assumptions of parametric tests are met, and using the Friedman test if the assumptions of parametric tests are not met. When the parametric conditions are met Paired t test will be used to compare the measurement values, and when the parametric conditions are not met, the Wilcoxon signed-rank test will be used. Multiple Regression Analysis will be used to determine the factors affecting the person's own perception of voince. Finally, statistical significance level was accepted as p<0.05.

Official Title
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Investigation of the Perceptual and Acoustic Characteristic of Voice in Trans Man

Conditions
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Gender Dysphoria, Voice Disorder Due to Transsexualism, Transgender Persons, Hormone Replacement Therapy

Intervention / Treatment
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* Other: Testosterone Hormon Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being diagnosed with Gender Dysphoria according to DSM 5 Having decided to start hormone therapy Exclusion Criteria: Diagnosis of vocal fold lesion in videolaryngostroboscopy evaluation Having previously received voice therapy or undergone voice surgery Having a systematic/or neurological disorder that may affect voice quality Having had hormone therapy or still on hormone therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trans man<br>Trans man is assigned female at birth and identify as man | Other: Testosterone Hormon Therapy<br>* Testosterone isocaproate, ... ml, once per 21 days for 6 months period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-perception of voice | Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score | change from baseline to 3rd month | 
| Change in Self-perception of voice | Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score | change from baseline to 6rd month | 
| Change in Self-perception of voice | Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score | change from 3rd months to 6th months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Acoustic Voice Characteristics | Digital recordings will be made using the Computerized Speech Lab (KayPENTAX) while performing the following tasks: sustained vowel /a:/, sponteous speech and Pinokyo passage reading. Voice recordings will be analyzed using the Real-Time Pitch Program and the Multidimensional Voice Program for measure F0, Mean F0, Jitter percent, Shimmer Percent, and noise-to-harmonic ratio (NHR). | change from baseline to 3rd month | 
| Change in Acoustic Voice Characteristics | Digital recordings will be made using the Computerized Speech Lab (KayPENTAX) while performing the following tasks: sustained vowel /a:/, sponteous speech and Pinokyo passage reading. Voice recordings will be analyzed using the Real-Time Pitch Program and the Multidimensional Voice Program for measure F0, Mean F0, Jitter percent, Shimmer Percent, and noise-to-harmonic ratio (NHR). | change from baseline to 6rd month | 
| Change in Acoustic Voice Characteristics | Digital recordings will be made using the Computerized Speech Lab (KayPENTAX) while performing the following tasks: sustained vowel /a:/, sponteous speech and Pinokyo passage reading. Voice recordings will be analyzed using the Real-Time Pitch Program and the Multidimensional Voice Program for measure F0, Mean F0, Jitter percent, Shimmer Percent, and noise-to-harmonic ratio (NHR). | change from 3rd months to 6th months | 
| Changes in the person's severity of depression | - Beck depression inventory (BDI) | change from baseline to 3rd month | 
| Changes in the person's severity of depression | - Beck depression inventory (BDI) | change from baseline to 6rd month | 
| Changes in the person's severity of depression | - Beck depression inventory (BDI) | change from 3rd months to 6th months | 
| Changes in the person's perception of support | - Multidimensional Scale of Perceived Social Support. | change from baseline to 3rd month | 
| Changes in the person's perception of support | - Multidimensional Scale of Perceived Social Support. | change from baseline to 6rd month | 
| Changes in the person's perception of support | - Multidimensional Scale of Perceived Social Support. | change from 3rd months to 6th months | 
| Changes in the person's anxiety level | - State-trait anxiety Inventory | change from baseline to 3rd month | 
| Changes in the person's anxiety level | - State-trait anxiety Inventory | change from baseline to 6rd month | 
| Changes in the person's anxiety level | - State-trait anxiety Inventory | change from 3rd months to 6th months | 
| Changes in the person's gender perception and gender transition process | - Transition questionnaire: The Transition Questionnaire is a self-report instrument that collects information on an individual's self-perception of status about the social and medical steps in the process of gender transition. | change from baseline to 3rd month | 
| Changes in the person's gender perception and gender transition process | - Transition questionnaire: The Transition Questionnaire is a self-report instrument that collects information on an individual's self-perception of status about the social and medical steps in the process of gender transition. | change from baseline to 6rd month | 
| Changes in the person's gender perception and gender transition process | - Transition questionnaire: The Transition Questionnaire is a self-report instrument that collects information on an individual's self-perception of status about the social and medical steps in the process of gender transition. | change from 3rd months to 6th months | 
| Changes in the person's body image perception | -Body cathexis scale | change from baseline to 3rd month | 
| Changes in the person's body image perception | -Body cathexis scale | change from baseline to 6rd month | 
| Changes in the person's body image perception | -Body cathexis scale | change from 3rd months to 6th months | 
| Change in testosterone level | Testosterone level measurement | change from baseline to 3rd month | 
| Change in testosterone level | Testosterone level measurement | change from baseline to 6rd month | 
| Change in testosterone level | Testosterone level measurement | change from 3rd months to 6th months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trans man voice, hormon therapy