NCT03899896

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2020

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

April 1, 2019

Last Update Submit

July 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

    1 year

  • Anxiety: State-Trait Anxiety Inventory, STAI-Y

    1 year

  • Self-esteem : Physical self inventory, 25 items (PSI-25)

    1 year

  • Depression: Center for Epidemiologic Studies Depression Scale, CES-D

    1 year

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Refusal or incapacity to be involved in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Communication DisordersGender Dysphoria

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersSexual Dysfunctions, Psychological

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 2, 2019

Study Start

February 28, 2019

Primary Completion

March 5, 2020

Study Completion

March 5, 2020

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations