Acoustic and Perceptual Effects of Intonation Training in Gender Diverse People

NCT05204732 | Completed DMC

• 1 other identifier: BC-11303
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Gender Dysphoria

Keywords

gender; gender perception; intonation; prosody; speech; gender diverse

Outcome Measures

Primary Outcomes (8)

• 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.

  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.)

• 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.

  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.)

• 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).

  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.)

• 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).

  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.)

• Gender perception of the voice

  A listening experiment with femininity ratings using a visual analogue scale (VAS: very feminine - neutral - very masculine).

  During a listening experiment (+/- 40 minutes).

• Change in patient's satisfaction with their voice - VAS

  Visual analoge scales investigating the client's satisfaction of the therapy and psychosocial functioning: examples: 1. My speech fits who I am (don't agree at all - neutral - completely agree) 2. How masculine/feminine do you sound while speaking? (very masculine - gender ambiguous (neutral) - very feminine) 3. 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) 4. After the training period, my pitch range increased (I can produce higher and/or lower tones). (don't agree at all - neutral - completely agree))

  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.)

• 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.

  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.)

• 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.

  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 (6)

• Change in speech fundamental frequency (SFF)

  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.)

• Change in formant frequency 1 (F1)

  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.)

• Change in formant frequency 2 (F2)

  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.)

• Change in formant frequency 3 (F3)

  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.)

• Change in formant frequency 4 (F4)

  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.)

Study Arms (2)

Experimental group

EXPERIMENTAL

* 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)

Other: Intonation training

Control group

SHAM COMPARATOR

* 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)

Other: Sham therapy + intonation training

Interventions

Intonation training OTHER

The participants will receive intonation training (1h/week) for four weeks, aiming for more gender congruent intonation patterns.

Experimental group

Sham therapy + intonation training OTHER

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).

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Gender diverse individuals: trans men, trans women and non binary persons
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal hearing (using ISO standard audiometry)
• Native Dutch speaker

You may not qualify if:

• A history of neurological disorders
• Previous phonosurgery or speech therapy
• Vocal pathology (using videolaryngostroboscopy)
• Smokers.

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, East Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Gender Dysphoria; Coitus; Speech

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders; Sexual Behavior; Behavior; Verbal Behavior; Communication

Study Officials

• Evelien D'haeseleer

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: January 24, 2022
• Study Start: March 30, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)