Investigation of the Perceptual and Acoustic Voice in Trans Man

Recruiting

• Conditions: Voice Disorder Due to Transsexualism; Transgender Persons; Gender Dysphoria; Hormone Replacement Therapy
• Interventions: Other: Testosterone Hormon Therapy

• Registration Number: NCT05166083
• Lead Sponsor: Hacettepe University

Brief Summary

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

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 8 doses of sex hormone use. Acoustic and perceptual changes in voice will be monitored at baseline (before hormone use), 4th dose, and 8th dose. 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 4. and 8. doses 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-11-13
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-21
• Study Start: 2022-03-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-01
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

• Being diagnosed with "Gender Dysphoria" according to DSM 5
• Having decided to start hormone therapy

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trans man	Testosterone Hormon Therapy	"Trans man" is assigned female at birth and identify as man

Primary Outcome Measures

Name	Time	Method
Change in Self-perception of voice	change from 4th to the 8th dose of hormone treatment	Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score

Secondary Outcome Measures

Name	Time	Method
Change in Acoustic Voice Characteristics	change from 4th to the 8th dose of hormone treatment	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).
Changes in the person's severity of depression	change from 4th to the 8th dose of hormone treatment	- Beck depression inventory (BDI)
Changes in the person's perception of support	change from 4th to the 8th dose of hormone treatment	- Multidimensional Scale of Perceived Social Support.
Changes in the person's anxiety level	change from 4th to the 8th dose of hormone treatment	- State-trait anxiety Inventory
Change in testosterone level	change from 4th to the 8th dose of hormone treatment	Testosterone level measurement
Changes in the person's gender perception and gender transition process	change from 4th to the 8th dose of hormone treatment	- 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.
Changes in the person's body image perception	change from 4th to the 8th dose of hormone treatment	-Body cathexis scale

Trial Locations

Locations (1)

Hacettepe University, Speech and Language Therapy; 🇹🇷 Ankara, Turkey