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临床试验/NCT04708600
NCT04708600已完成不适用

Effectiveness of Speech Therapy in Trans Women.

University Ghent2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2019年9月1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
78
试验地点
2
主要终点
Acoustics: change in formant frequencies

研究概览

简要总结

One of the greatest hurdles in the transition of transgender persons is that voice, speech and communication are not congruent with the desired gender. Since hormone treatment does not affect the voice in male-to-female transgender persons (trans women), speech therapy is the treatment of choice to develop a more feminine communication. Speech therapy must focus on aspects of communication that play an important role in listener perceptions of the speakers gender. Results of a systematic review and meta-analysis showed that those aspects are primarily fundamental frequency of the voice and resonance. However, effectiveness studies of speech interventions in transwomen are extremely limited and show methodological limitations. The purpose of this project is to investigate the short-term and longterm impact of speech exercises for pitch and resonance on (a) acoustic voice characteristics, (b) listener perceptions of femininity using a visual analogue scale and binary gender identification (male versus female voice), and (c) self-perception and psychosocial functioning in trans women using a randomized sham-controlled trial and cross-over design.

详细描述

The main aim of this project is to investigate the short-term and long-term effect of speech therapy for pitch and resonance on vocal characteristics, listeners' perceptions and self-perception in trans women using a randomized sham-controlled trial and a longitudinal cross-over design. The goals of speech therapy are selected based on a systematic review and meta-analysis: pitch and resonance.

The first purpose is to determine and compare the short-term effect of two therapy programs Pitch Elevation Therapy (PET) and Articulation-Resonance Therapy (ART), in trans women on (a) acoustic voice characteristics investigating vocal quality, pitch and resonance, (b) listeners' perceptions using a combination of (binary) gender identification and femininity ratings using a Visual Analogue Scale (VAS) and (c) self-assessment investigating the client's satisfaction of the therapy and psychosocial functioning, using a randomized controlled trial.

Hypotheses:

  1. Outcome acoustic voice characteristics: Based on studies and our pilot study investigating the immediate effects of resonance and articulation exercises in trans women, a significant increase in all formant frequencies, and an increase in speaking fo is hypothesized after ART. Based on studies, an increase in speaking fo between 10 and 84Hz is hypothesized after PET. The speaking fo and formant frequencies are primary outcome measures.

Vocal training and increasing pitch (during the PET) is associated with increasing vocal load and has a possible negative effect on vocal quality. Monitoring vocal quality in the three groups is therefore important. PET includes gliding tones and consequently can have a possible effect on frequency range. Therefore vocal quality and vocal range parameters are included as secondary outcome parameters. PET and ART are designed to feminize the voice without vocal misuse. Therefore, measurements of vocal quality are hypothesized to remain stable after treatment. After PET, an increase in vocal range is hypothesized. 2. Outcome listeners perceptions: According to the systematic review and meta-analysis of Leung et al., pitch and resonance are the most salient listener perceptions of speaker gender. Based on the results of our pilot study, and other studies, it is hypothesized that both therapy programs, PET and ART, will result in a more feminine speech rated on a VAS. Based on the results of Gelfer et al. we hypothesize that 50% of the participants will be perceived as female after the PET therapy. 3. Outcome self-assessment: Based on a retrospective study, case studies, and another study, significant improvement in psychosocial wellbeing and high levels of satisfaction with the post-treatment voice are hypothesized in both programs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • established diagnose and gender identity confirmed by the gender team,
  • aged between 18 and 70 years,
  • self-reported normal hearing,
  • native Dutch speaker,
  • under hormonal treatment (confirmed by blood analysis),
  • female gender role, perceived as male speaker at the beginning of the therapy by the investigators
  • speaking fo within the male or ambiguous zone (<180Hz).

排除标准

  • history of neurological disorders, previous phonosurgery or speech therapy
  • pathology of the vocal folds (observed by videolaryngostroboscopic examination of the vocal cords),
  • to form a homogeneous study population gender non-binary persons will not be included in this study.

结局指标

主要结局

Acoustics: change in formant frequencies

时间窗: pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year)

Median Formant Frequencies F1-F5 of the vowels /a/, /i/, /u/

Acoustics: change in speaking fundamental frequency

时间窗: pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year)

Median Speaking fo, fo upper limit (pc95), fo lower limit (pc25)

Change in listeners perceptions

时间窗: pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year)

masculinity/femininity ratings (using a VAS) and gender identification

Change in self-assessment

时间窗: pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year)

Trans women voice questionnaire

次要结局

  • Change in Dysphonia Severity Index(pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year))
  • Change in Voice Range Profile(pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year))
  • Change in Acoustic Voice Quality Index(pre, post 1 (immediately after sham), post 2 (immediately after intervention 1), post 3 (immediately after intervention 2), follow-up 1 (after 3 months), follow-up 2 (after 1 year))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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