Investigation of the Perceptual and Acoustic Voice in Trans Man

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gender Dysphoria; Hormone Replacement Therapy; Transgender Persons; Voice Disorder Due to Transsexualism
• Intervention / Treatment: Other: Testosterone Hormon Therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 28

Contacts and Locations

• Study Contact: Name: Fatma Esen AYDINLI, Assoc. Prof.; Phone Number: +903123051093; Email: fesen04@hacettepe.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Hacettepe University, Speech and Language Therapy
    • Contact: MERVE OGULMUS, SLP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Trans men who are followed in Hacettepe University Hospital Endocrinology and Psychiatry Clinics.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trans man; "Trans man" is assigned female at birth and identify as man	Other: Testosterone Hormon Therapy; Testosterone isocaproate, ... ml, 8 doses, once per 21 days

What is the study measuring?

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

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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Director: Fatma Esen AYDINLI, Assoc. Prof., Hacettepe University, Speech and Language Therapy Departmant; Study Chair: Merve OGULMUS, SLP., Hacettepe University, Speech and Language Therapy; Study Chair: Koray Baser, Assoc. Prof., Hacettepe Univeristy, Faculty of Medicine, Mental Health and Disease Department; Study Chair: Bulent Okan YILDIZ, Prof., Hacettepe University, Faculty of Medicine, Endocrinology department; Study Chair: Taner YILMAZ, Prof., Hacettepe University, Faculty of Medicine, Otorhinolaryngology department

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 13, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Trans man voice, hormon therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Sexual Dysfunctions, Psychological; Laryngeal Diseases; Gender Dysphoria; Voice Disorders; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: HUSLPTRANSMANVOICE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No