Clinical trial NCT05204732: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gender Dysphoria
Keywords: gender
gender perception
intonation
prosody
speech
gender diverse
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in general intonation shift (Hz and ERB)
timeFrame: 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.)
measure: Change in final intonation shift (Hz and ERB)
timeFrame: 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.)
measure: Change in general pitch range (Hz and ERB)
timeFrame: 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.)
measure: Change in pitch variation index (Hz/s and ERB/s)
timeFrame: 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.)
measure: Gender perception of the voice
timeFrame: During a listening experiment (+/- 40 minutes).
measure: Change in patient's satisfaction with their voice - VAS
timeFrame: 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.)
measure: Change in patient's satisfaction with their voice - TWVQ
timeFrame: 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.)
measure: Change in patient's satisfaction with their voice - VHI
timeFrame: 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 outcomes:
measure: Change in speech fundamental frequency (SFF)
timeFrame: 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.)
measure: Change in formant frequency 1 (F1)
timeFrame: 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.)
measure: Change in formant frequency 2 (F2)
timeFrame: 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.)
measure: Change in formant frequency 3 (F3)
timeFrame: 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.)
measure: Change in formant frequency 4 (F4)
timeFrame: 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.)
measure: Change in formant frequency 5 (F5)
timeFrame: 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.)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: East Flanders
Study officials:
affiliation: University Ghent
name: Evelien D'haeseleer
role: PRINCIPAL_INVESTIGATOR
References: