Acoustic and Perceptual Effects of Intonation Training in Gender Diverse People
Primary Purpose
Gender Dysphoria
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Intonation training
Sham therapy + intonation training
Sponsored by
About this trial
This is an interventional treatment trial for Gender Dysphoria focused on measuring gender, gender perception, intonation, prosody, speech, gender diverse
Eligibility Criteria
Inclusion Criteria:
- Normal hearing (using ISO standard audiometry)
- Native Dutch speaker
Exclusion Criteria:
- A history of neurological disorders
- Previous phonosurgery or speech therapy
- Vocal pathology (using videolaryngostroboscopy)
- Smokers.
Sites / Locations
- Ghent UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental group
Control group
Arm Description
Speech training: 4 times 1 hour of intonation training for 4 weeks Standard voice assessment (voice recording, VAS, questionnaire(s)) (1 premeasurement and 2 postmeasurements)
Speech training: : 4 times 1 hour sham therapy (info sessions + active intervention non-verbal communication) during 4 weeks + 4 times 1 hour intonation training during 4 weeks Standard voice assessment (voice recording, VAS, questionnaire(s)) (1 premeasurement and 3 postmeasurements)
Outcomes
Primary Outcome Measures
Change in general intonation shift (Hz and ERB)
The general intonation shift is the mean size of the general increase or decrease of the fundamental frequency during the utterance. For the calculation of this parameter, the first and last vowel of the sentence were selected and the fo of the vowels were determined. Subsequently, the general intonation shift was calculated as the difference between start and end fo. Based on the size of this difference, the general intonation shift was categorized as an upward, downward or flat intonation shift. A difference smaller than 1.570884399 ERB was considered as a flat intonation shift. Finally, the percentage of upward, downward and flat intonation shifts could be determined.
Change in final intonation shift (Hz and ERB)
The Final intonation shift indicates the average size of the upward or downward intonation shift at the end of the utterance. This parameter was calculated as the difference between the fo at the beginning of the final rise or drop and the fo at the end. The beginning was located on the last stressed vowel and the end of the final rise or drop was located on the last unstressed vowel. In case that the utterance ended with a stressed vowel, the intonation shift was derived from the difference in fo within this vowel.
Change in general pitch range (Hz and ERB)
This parameter was calculated as the difference between the minimum (5th percentile) and the maximum fo (95th percentile) of the utterance. For this calculation the "Intonantion and stress trajectory" script was used (Corthals, 2019a; Van Borsel, Vandaele, & Corthals, 2013).
Change in pitch variation index (Hz/s and ERB/s)
This parameter was determined by the sum of the absolute value of all pitch changes during the utterance between percentile 5 and 95 divided by the total duration of the utterance. The pitch variation index reflects the size and speed of the intonation maneuvers. For this parameter the script "Intonation and stress trajectory" was used (Corthals, 2019a; Van Borsel, Vandaele, & Corthals, 2013).
Gender perception of the voice
A listening experiment with femininity ratings using a visual analogue scale (VAS: very feminine - neutral - very masculine).
Change in patient's satisfaction with their voice - VAS
Visual analoge scales investigating the client's satisfaction of the therapy and psychosocial functioning:
examples:
My speech fits who I am (don't agree at all - neutral - completely agree)
How masculine/feminine do you sound while speaking? (very masculine - gender ambiguous (neutral) - very feminine)
While speaking, there is a wide variation of my pitch. (don't agree at all - neutral - completely agree) (3) I sound more feminine/male/neutral compared to before the training period. (don't agree at all - neutral - completely agree)
After the training period, my pitch range increased (I can produce higher and/or lower tones). (don't agree at all - neutral - completely agree))
Change in patient's satisfaction with their voice - TWVQ
Trans Women Voice Questionnaire: 30 questions investigating trans women's experiences with their voice (1 = never or seldom; 2 = sometimes; 3 = often; 4 = usual or always). The score can range from 30 to 120. A lower score indicates higher satisfaction with the voice.
Change in patient's satisfaction with their voice - VHI
Voice Handicap Index: 30 questions investigating the impact of voice on the quality of life (0 = never; 1 = almost never; 2 = sometimes; 3 = almost always; 4 = always) . The score can range from 30 to 120. A lower score indicates higher satisfaction with the voice.
Secondary Outcome Measures
Change in speech fundamental frequency (SFF)
median speech fundamental frequency (SFF)
Change in formant frequency 1 (F1)
F1 of the vowels /a/, /i/ and /u/
Change in formant frequency 2 (F2)
F2 of the vowels /a/, /i/ and /u/
Change in formant frequency 3 (F3)
F3 of the vowels /a/, /i/ and /u/
Change in formant frequency 4 (F4)
F4 of the vowels /a/, /i/ and /u/
Change in formant frequency 5 (F5)
F5 of the vowels /a/, /i/ and /u/
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05204732
Brief Title
Acoustic and Perceptual Effects of Intonation Training in Gender Diverse People
Official Title
Acoustic and Perceptual Effects of Intonation Training in Gender Diverse People
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
October 26, 2026 (Anticipated)
Study Completion Date
October 26, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this project is to investigate the short- and the longer-term effect of intonation training on vocal characteristics, listener perceptions and patient related outcome measures (PROMS) in gender diverse people using a randomized sham-controlled trial.
Detailed Description
Background and Problem Statement. Speech training in gender diverse individuals focuses on aspects of communication that strongly influence gender perception. Findings from the literature suggest that a listener's gender perception is determined not only by pitch, but also by other components such as intonation. However, the nature and extent of pitch changes required to alter gender perception are not known. In speech therapy, intonation training is frequently used for speech feminization. However, empirical evidence for this is lacking.
Research questions and/or hypotheses Thisresearch investigates the short- and long-term effects of intonation training on acoustic voice characteristics, gender perception and findings of gender-diverse individuals using a randomized sham-controlled trial (RCT). Based on findings from the literature, (a) gender-congruent values are expected for intonation parameters, in addition (b) assessments of gender that fit the gender identity of the person and (c) an improvement in self-assessment after intonation training in the short and long term. This study will lead to new insights into the relationship between intonation and gender perception and makes an important contribution to the evidence for the use of intonation training.
Research Protocol An RCT will be used. Gender diverse individuals will be recruited through the Ghent University Hospital. Inclusion criteria are: diagnosis of gender dysphoria established by the multidisciplinary gender team, age between 18 and 60 years, normal hearing and Dutch mother tongue. Taking into account the expertise of the research group and the low-threshold recruitment through the gender clinic of UZ Gent, a total of n=20 participants is a very feasible number. Subjects will be randomly assigned to the experimental (intonation training) or control group (receiving a placebo intervention). Randomization will be stratified by age group and baseline speaking fundamental frequency. The experimental group will receive 4 weeks (1h/week) of intonation training with a pre- and post-voice assessment and a follow-up assessment after 8 weeks. The control group will receive sham therapy at a similar duration and frequency, also with a pre- and post-measurement and a follow-up assessment after 8 weeks. The control group will receive 4 more weeks (1 hour/week) of intonation training with a post measurement (due to ethical reasons). The multidimensional speech assessments will be blinded and completed and well-defined training programs will be used. The primary outcome measures are: acoustic intonation parameters, gender perception by listeners and self-assessment and client satisfaction. Linear mixed models with post-hoc pairwise comparisons will be used to analyze the evolution of continuous data within and between groups. ICC models and Cohen's kappa will be used to analyze inter- and intra rater reliability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gender Dysphoria
Keywords
gender, gender perception, intonation, prosody, speech, gender diverse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Speech training: 4 times 1 hour of intonation training for 4 weeks
Standard voice assessment (voice recording, VAS, questionnaire(s)) (1 premeasurement and 2 postmeasurements)
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Speech training: : 4 times 1 hour sham therapy (info sessions + active intervention non-verbal communication) during 4 weeks + 4 times 1 hour intonation training during 4 weeks
Standard voice assessment (voice recording, VAS, questionnaire(s)) (1 premeasurement and 3 postmeasurements)
Intervention Type
Other
Intervention Name(s)
Intonation training
Intervention Description
The participants will receive intonation training (1h/week) for four weeks, aiming for more gender congruent intonation patterns.
Intervention Type
Other
Intervention Name(s)
Sham therapy + intonation training
Intervention Description
The participants will first receive four weeks of sham therapy (with no expected effect on speech), during which information on voice functioning, voice surgery, voice hygiene, and transgender health care will be provided. In addition, during sham therapy, active intervention will be given around nonverbal communication. After four weeks of sham therapy, for ethical reasons, subjects in this group will also receive four weeks of intonation training (aiming for more gender congruent intonation patterns).
Primary Outcome Measure Information:
Title
Change in general intonation shift (Hz and ERB)
Description
The general intonation shift is the mean size of the general increase or decrease of the fundamental frequency during the utterance. For the calculation of this parameter, the first and last vowel of the sentence were selected and the fo of the vowels were determined. Subsequently, the general intonation shift was calculated as the difference between start and end fo. Based on the size of this difference, the general intonation shift was categorized as an upward, downward or flat intonation shift. A difference smaller than 1.570884399 ERB was considered as a flat intonation shift. Finally, the percentage of upward, downward and flat intonation shifts could be determined.
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 20 min.)
Title
Change in final intonation shift (Hz and ERB)
Description
The Final intonation shift indicates the average size of the upward or downward intonation shift at the end of the utterance. This parameter was calculated as the difference between the fo at the beginning of the final rise or drop and the fo at the end. The beginning was located on the last stressed vowel and the end of the final rise or drop was located on the last unstressed vowel. In case that the utterance ended with a stressed vowel, the intonation shift was derived from the difference in fo within this vowel.
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 20 min.)
Title
Change in general pitch range (Hz and ERB)
Description
This parameter was calculated as the difference between the minimum (5th percentile) and the maximum fo (95th percentile) of the utterance. For this calculation the "Intonantion and stress trajectory" script was used (Corthals, 2019a; Van Borsel, Vandaele, & Corthals, 2013).
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 20 min.)
Title
Change in pitch variation index (Hz/s and ERB/s)
Description
This parameter was determined by the sum of the absolute value of all pitch changes during the utterance between percentile 5 and 95 divided by the total duration of the utterance. The pitch variation index reflects the size and speed of the intonation maneuvers. For this parameter the script "Intonation and stress trajectory" was used (Corthals, 2019a; Van Borsel, Vandaele, & Corthals, 2013).
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 20 min.)
Title
Gender perception of the voice
Description
A listening experiment with femininity ratings using a visual analogue scale (VAS: very feminine - neutral - very masculine).
Time Frame
During a listening experiment (+/- 40 minutes).
Title
Change in patient's satisfaction with their voice - VAS
Description
Visual analoge scales investigating the client's satisfaction of the therapy and psychosocial functioning:
examples:
My speech fits who I am (don't agree at all - neutral - completely agree)
How masculine/feminine do you sound while speaking? (very masculine - gender ambiguous (neutral) - very feminine)
While speaking, there is a wide variation of my pitch. (don't agree at all - neutral - completely agree) (3) I sound more feminine/male/neutral compared to before the training period. (don't agree at all - neutral - completely agree)
After the training period, my pitch range increased (I can produce higher and/or lower tones). (don't agree at all - neutral - completely agree))
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 5 min.)
Title
Change in patient's satisfaction with their voice - TWVQ
Description
Trans Women Voice Questionnaire: 30 questions investigating trans women's experiences with their voice (1 = never or seldom; 2 = sometimes; 3 = often; 4 = usual or always). The score can range from 30 to 120. A lower score indicates higher satisfaction with the voice.
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 5 min.)
Title
Change in patient's satisfaction with their voice - VHI
Description
Voice Handicap Index: 30 questions investigating the impact of voice on the quality of life (0 = never; 1 = almost never; 2 = sometimes; 3 = almost always; 4 = always) . The score can range from 30 to 120. A lower score indicates higher satisfaction with the voice.
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 5 min.)
Secondary Outcome Measure Information:
Title
Change in speech fundamental frequency (SFF)
Description
median speech fundamental frequency (SFF)
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 5 min.)
Title
Change in formant frequency 1 (F1)
Description
F1 of the vowels /a/, /i/ and /u/
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 5 min.)
Title
Change in formant frequency 2 (F2)
Description
F2 of the vowels /a/, /i/ and /u/
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 5 min.)
Title
Change in formant frequency 3 (F3)
Description
F3 of the vowels /a/, /i/ and /u/
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 5 min.)
Title
Change in formant frequency 4 (F4)
Description
F4 of the vowels /a/, /i/ and /u/
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 5 min.)
Title
Change in formant frequency 5 (F5)
Description
F5 of the vowels /a/, /i/ and /u/
Time Frame
baseline (before treatment) - at the end of the treatment period (after 4 weeks) - 4 (and 8) weeks after the end of the treatment period (after 8 (and 12) weeks (each measurement +/- 5 min.)
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Gender diverse individuals: trans men, trans women and non binary persons
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal hearing (using ISO standard audiometry)
Native Dutch speaker
Exclusion Criteria:
A history of neurological disorders
Previous phonosurgery or speech therapy
Vocal pathology (using videolaryngostroboscopy)
Smokers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tine Papeleu
Phone
0471725172
Email
tine.papeleu@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelien D'haeseleer
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University
City
Ghent
State/Province
East Flanders
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tine Papeleu
Phone
0471725172
Email
tine.papeleu@ugent.be
First Name & Middle Initial & Last Name & Degree
Evelien D'haeseleer
12. IPD Sharing Statement
Plan to Share IPD
No
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Acoustic and Perceptual Effects of Intonation Training in Gender Diverse People
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