Investigation of the Perceptual and Acoustic Voice in Trans Man

NCT ID: NCT05166083

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-11
• Study Completion Date: 2025-01-20

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Trans man

"Trans man" is assigned female at birth and identify as man

Testosterone Hormon Therapy

Intervention Type: OTHER

Testosterone isocaproate, ... ml, 8 doses, once per 21 days

Interventions

Testosterone Hormon Therapy

Testosterone isocaproate, ... ml, 8 doses, once per 21 days

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

MERVE OGULMUS UYSAL

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma Esen AYDINLI, Assoc. Prof.

Role: STUDY_DIRECTOR

Hacettepe University, Speech and Language Therapy Departmant

Merve OGULMUS, SLP.

Role: STUDY_CHAIR

Hacettepe University, Speech and Language Therapy

Koray Baser, Assoc. Prof.

Role: STUDY_CHAIR

Hacettepe Univeristy, Faculty of Medicine, Mental Health and Disease Department

Bulent Okan YILDIZ, Prof.

Role: STUDY_CHAIR

Hacettepe University, Faculty of Medicine, Endocrinology department

Taner YILMAZ, Prof.

Role: STUDY_CHAIR

Hacettepe University, Faculty of Medicine, Otorhinolaryngology department

Locations

Hacettepe University, Speech and Language Therapy

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HUSLPTRANSMANVOICE

Identifier Type: -

Identifier Source: org_study_id