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临床试验/NCT05166083
NCT05166083已完成不适用

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

Hacettepe University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Change in Self-perception of voice

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Change in Self-perception of voice

时间窗: 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

次要结局

  • Change in Acoustic Voice Characteristics(change from 4th to the 8th dose of hormone treatment)
  • Changes in the person's severity of depression(change from 4th to the 8th dose of hormone treatment)
  • Changes in the person's perception of support(change from 4th to the 8th dose of hormone treatment)
  • Changes in the person's anxiety level(change from 4th to the 8th dose of hormone treatment)
  • Change in testosterone level(change from 4th to the 8th dose of hormone treatment)
  • Changes in the person's gender perception and gender transition process(change from 4th to the 8th dose of hormone treatment)
  • Changes in the person's body image perception(change from 4th to the 8th dose of hormone treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MERVE OGULMUS UYSAL

Principal Investigator

Hacettepe University

研究点 (1)

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