Voice Feminisation in Transgender Women (FemVoc)

The voice is a reflection of our identity. In the case of transgender women, there may be a gap between perceived male voice and female appearance. Indeed, hormonal treatment in transgender women has no effect on the voice quality. This gap can have negative consequences on everyday life in banal situations such as telephonic contact leading to limited use of phone calls and social isolation.

Differences between female and male voices seem to be socially determined and do not depend directly on sexual dimorphism of the phonatory organs.

Speech therapy might thus be indicated as a vocal support for transgender women.

Only few studies have examined the impact of perceived voice on the quality of life of transgender women.

Study Overview

• Status: Completed
• Conditions: Gender Dysphoria; Transgender Women; Speech Therapy

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les nancy, France, 54511
    • University Hospital Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Participation to the study will be proposed consecutively to all subjects, fulfilling inclusion criteria, attending in-office follow-up visit for gender dysphoria in the Department of Endocrinology, Diabetology and Nutrition of the University Hospital of Nancy

Description

Inclusion Criteria:

• Age ≥ 18 years
• Follow-up in the Department of Endocrinology, Diabetology and Nutrition of the University Hospital of Nancy
• Gender dysphoria according to the ICD 11
• Voluntary, informed consent to participate in research
• Compulsory affiliation to the social security system

Exclusion Criteria:

-Refusal or incapacity to be involved in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the perceptions of transgender women regarding their voice	Transsexual voice questionnaire Male-to-Female Transsexuals (Dacakis G et al J Voice, 2017): the questionnaire evaluates voice perception in 6 domains: 1 / effect of voice on ease of social interactions, 2 / effect of voice on emotions; 3 / relationship between voice and gender identity, 4 / effort and concentration required to produce voice; 5 / physical aspects of voice production; 6 / pitch. The questionnaire has 30 items. The subject indicates on a 4-point Likert scale ranging from "never or rarely" to "often enough or all the time", the frequency with which he usually feels the symptoms listed. The score is calculated from a minimum of 30 points to a maximum of 120 points	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
generic quality of life: physical functioning, limitations due to physical state, pain, mental health, limitations due to mental state, social health, vitality and global health	Questionnaire (Short form 36 health survey) The SF-36 is a generic quality of life self-questionnaire with 36 items grouped in 8 dimensions (physical functioning, limitations due to physical state, pain, mental health, limitations due to mental state, social health, vitality and global health). For each dimension a quality of life score is calculated and normalized between 0 (worst possible QoL) and 100 (best QoL possible).	1 year
Anxiety: State-Trait Anxiety Inventory, STAI-Y	The STAI-Y assesses anxiety as a personality trait and as a specific emotional response to a situation. The first part, STAI-Y-1, consists of 20 sentences assessing the current emotional state of the subject. The second part, STAI-Y-2, consists of 20 sentences assessing the subject's usual emotional state.; Each answer to an item in the STAI-Y is scored from 1 to 4, with 1 indicating the lowest degree of anxiety and 4 the highest degree of anxiety.; In the STAI-Y-1, the subject indicates the intensity of his feelings on a 4-point Likert scale ranging from "not at all" to "many". In the STAI-Y-2, the subject indicates on a 4-point Likert scale ranging from "almost never" to "almost always", a frequency at which he usually feels the symptoms listed.; To obtain the score for the STAI-Y-1, the scores for the 20 items (1 to 20) are summed. To obtain the STAI-Y-2 score, the scores for the 20 items (21 to 40) are summed. Each score can therefore vary from 20 to 80.	1 year
Self-esteem : Physical self inventory, 25 items (PSI-25)	The PSI-25 is an inventory of self-esteem relating to the body domain.; This tool consists of 6 scales: at the general level, the overall self-esteem scale, at the physical domain level: the perceived physical value scale, and at the subdomain level, 4 subscales: the fitness, athletic competence, physical appearance and strength. It has 25 items; The subject responds on the Likert scale in 6 increasing degrees (it looks like me 1: not at all, 2: very little, 3: a little, 4: enough, 5: a lot, 6: quite).; The score ranges from 5 to 30 for each scale, total score is averaged.	1 year
Depression: Center for Epidemiologic Studies Depression Scale, CES-D	• The CES-D assesses the frequency and severity of depressive symptoms presented by the general population. The questionnaire has 20 items.; The subject indicates on a 4-point Likert scale ranging from "almost never" to "almost always", a frequency at which he usually feels the symptoms listed.; Score is calculated from 0 to 60 (maximum score indicating strong expression of symptoms)	1 year

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2019
• Primary Completion (ACTUAL): March 5, 2020
• Study Completion (ACTUAL): March 5, 2020

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (ACTUAL): April 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Sexual Dysfunctions, Psychological; Neurodevelopmental Disorders; Gender Dysphoria; Communication Disorders; Feminization
• Other Study ID Numbers: 2019 (Chief Medical Office (CMO) Alberta Health Services)

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