Clinical trial NCT05166083: Investigation of the Perceptual and Acoustic Voice in Trans Man
Official title: Investigation of the Perceptual and Acoustic Characteristic of Voice in Trans Man
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gender Dysphoria
Voice Disorder Due to Transsexualism
Transgender Persons
Hormone Replacement Therapy
Keywords: Trans man voice, hormon therapy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trans men who are followed in Hacettepe University Hospital Endocrinology and Psychiatry Clinics.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Self-perception of voice
timeFrame: change from baseline to the 4th dose of hormone treatment
measure: Change in Self-perception of voice
timeFrame: change from baseline to the 8th dose of hormone treatment
measure: Change in Self-perception of voice
timeFrame: change from 4th to the 8th dose of hormone treatment
Secondary outcomes:
measure: Change in Acoustic Voice Characteristics
timeFrame: change from baseline to the 4th dose of hormone treatment
measure: Change in Acoustic Voice Characteristics
timeFrame: change from baseline to the 8th dose of hormone treatment
measure: Change in Acoustic Voice Characteristics
timeFrame: change from 4th to the 8th dose of hormone treatment
measure: Changes in the person's severity of depression
timeFrame: change from baseline to the 4th dose of hormone treatment
measure: Changes in the person's severity of depression
timeFrame: change from baseline to the 8th dose of hormone treatment
measure: Changes in the person's severity of depression
timeFrame: change from 4th to the 8th dose of hormone treatment
measure: Changes in the person's perception of support
timeFrame: change from baseline to the 4th dose of hormone treatment
measure: Changes in the person's perception of support
timeFrame: change from baseline to the 8th dose of hormone treatment
measure: Changes in the person's perception of support
timeFrame: change from 4th to the 8th dose of hormone treatment
measure: Changes in the person's anxiety level
timeFrame: change from baseline to the 4th dose of hormone treatment
measure: Changes in the person's anxiety level
timeFrame: change from baseline to the 8th dose of hormone treatment
measure: Changes in the person's anxiety level
timeFrame: change from 4th to the 8th dose of hormone treatment
measure: Changes in the person's gender perception and gender transition process
timeFrame: change from baseline to the 4th dose of hormone treatment
measure: Changes in the person's gender perception and gender transition process
timeFrame: change from baseline to the 8th dose of hormone treatment
measure: Changes in the person's gender perception and gender transition process
timeFrame: change from 4th to the 8th dose of hormone treatment
measure: Changes in the person's body image perception
timeFrame: change from baseline to the 4th dose of hormone treatment
measure: Changes in the person's body image perception
timeFrame: change from baseline to the 8th dose of hormone treatment
measure: Changes in the person's body image perception
timeFrame: change from 4th to the 8th dose of hormone treatment
measure: Change in testosterone level
timeFrame: change from baseline to the 4th dose of hormone treatment
measure: Change in testosterone level
timeFrame: change from baseline to the 8th dose of hormone treatment
measure: Change in testosterone level
timeFrame: change from 4th to the 8th dose of hormone treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Speech and Language Therapy
Study officials:
affiliation: Hacettepe University, Speech and Language Therapy Departmant
name: Fatma Esen AYDINLI, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Hacettepe University, Speech and Language Therapy
name: Merve OGULMUS, SLP.
role: STUDY_CHAIR
affiliation: Hacettepe Univeristy, Faculty of Medicine, Mental Health and Disease Department
name: Koray Baser, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Hacettepe University, Faculty of Medicine, Endocrinology department
name: Bulent Okan YILDIZ, Prof.
role: STUDY_CHAIR
affiliation: Hacettepe University, Faculty of Medicine, Otorhinolaryngology department
name: Taner YILMAZ, Prof.
role: STUDY_CHAIR
References: