Investigation of the Perceptual and Acoustic Voice in Trans Man

Sponsor
Hacettepe University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05166083
Collaborator
(none)
28
1
13.7
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
28 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Investigation of the Perceptual and Acoustic Characteristic of Voice in Trans Man
Actual Study Start Date :
Mar 11, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Trans man

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

Other: Testosterone Hormon Therapy
Testosterone isocaproate, ... ml, once per 21 days for 6 months period.

Outcome Measures

Primary Outcome Measures

  1. Change in Self-perception of voice [change from baseline to 3rd month]

    Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score

  2. Change in Self-perception of voice [change from baseline to 6rd month]

    Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score

  3. Change in Self-perception of voice [change from 3rd months to 6th months]

    Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score

Secondary Outcome Measures

  1. Change in Acoustic Voice Characteristics [change from baseline to 3rd month]

    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).

  2. Change in Acoustic Voice Characteristics [change from baseline to 6rd month]

    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).

  3. Change in Acoustic Voice Characteristics [change from 3rd months to 6th months]

    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).

  4. Changes in the person's severity of depression [change from baseline to 3rd month]

    - Beck depression inventory (BDI)

  5. Changes in the person's severity of depression [change from baseline to 6rd month]

    - Beck depression inventory (BDI)

  6. Changes in the person's severity of depression [change from 3rd months to 6th months]

    - Beck depression inventory (BDI)

  7. Changes in the person's perception of support [change from baseline to 3rd month]

    - Multidimensional Scale of Perceived Social Support.

  8. Changes in the person's perception of support [change from baseline to 6rd month]

    - Multidimensional Scale of Perceived Social Support.

  9. Changes in the person's perception of support [change from 3rd months to 6th months]

    - Multidimensional Scale of Perceived Social Support.

  10. Changes in the person's anxiety level [change from baseline to 3rd month]

    - State-trait anxiety Inventory

  11. Changes in the person's anxiety level [change from baseline to 6rd month]

    - State-trait anxiety Inventory

  12. Changes in the person's anxiety level [change from 3rd months to 6th months]

    - State-trait anxiety Inventory

  13. Changes in the person's gender perception and gender transition process [change from baseline to 3rd month]

    - 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.

  14. Changes in the person's gender perception and gender transition process [change from baseline to 6rd month]

    - 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.

  15. Changes in the person's gender perception and gender transition process [change from 3rd months to 6th months]

    - 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.

  16. Changes in the person's body image perception [change from baseline to 3rd month]

    -Body cathexis scale

  17. Changes in the person's body image perception [change from baseline to 6rd month]

    -Body cathexis scale

  18. Changes in the person's body image perception [change from 3rd months to 6th months]

    -Body cathexis scale

  19. Change in testosterone level [change from baseline to 3rd month]

    Testosterone level measurement

  20. Change in testosterone level [change from baseline to 6rd month]

    Testosterone level measurement

  21. Change in testosterone level [change from 3rd months to 6th months]

    Testosterone level measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University, Speech and Language Therapy Ankara Turkey

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MERVE OGULMUS, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier:
NCT05166083
Other Study ID Numbers:
  • HUSLPTRANSMANVOICE
First Posted:
Dec 21, 2021
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by MERVE OGULMUS, Principal Investigator, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022