Speech TherapyFemVocNCT03899896
Voice Feminisation in Transgender Women
An observational study of Speech Therapy and Transgender Women, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Speech Therapy, Transgender Women, Gender Dysphoria
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2019to 5 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- -Refusal or incapacity to be involved in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Speech Therapy, Transgender Women, Gender Dysphoria
- Medical subject headings
- Communication Disorders, Gender Dysphoria
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start28 Feb 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech TherapyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899896
- Sponsor's protocol ID
- 2019
- Acronym
- FemVoc
- Status last verified
- Jul 2022
- First submitted
- 1 Apr 2019
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Feminisation in Transgender Women
- ClinicalTrials.gov ID
- NCT03899896
- Acronym / sponsor ID
- FemVoc / 2019
- Conditions
- Speech Therapy, Transgender Women, Gender Dysphoria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -Refusal or incapacity to be involved in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To measure the perceptions of transgender women regarding their voice
Time frame: 1 year
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
4 secondary outcomes
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
Time frame: 1 year
Anxiety: State-Trait Anxiety Inventory, STAI-Y
Time frame: 1 year
Self-esteem : Physical self inventory, 25 items (PSI-25)
Time frame: 1 year
Depression: Center for Epidemiologic Studies Depression Scale, CES-D
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Speech Therapy and Transgender Women, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the perceptions of transgender women regarding their voice (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.