Randomized controlled trial of text-to-speech communication versus standard of care in patients on prescribed voice rest

Study ID
STU 022012-061

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services

Contact
Kristy Carter
214-648-3626
kristy.carter@utsouthwestern.edu

Principal Investigator
I-Fan Mau

Summary

Subjects will be randomized to an experimental group or a control group. The experimental group will receive the standard-of-care treatment of voice rest for 7 days plus a TTS device, while the control group will receive only the standard-of-care treatment of voice rest for 7 days.
The study will involve: 1) a 15-20 minute training session to orient subjects to the TTS device (if randomized to receive), and 2) completion of study-related questionnaires both prior to and during their prescribed voice rest. The study-related instruments will evaluate the amount of pre- and post-surgical voice use, utilization of the device and/or other means of non-speech communication, and the impact of voice rest on study participant's day-to-day lives.
The outcome variables are:
1) Communication effectiveness during the period of voice rest, as self-reported on a 100-mm visual analogue scale (VaS), anchored by 0 (not at all) and 10 (every time i wanted to communicate), in response to the question [Quote]i was able to communicative effectively today without using my voice or whispering[Quote].
2) Cumulative magnitude of voice use over the seven-day period of voice rest, as measured on a 100-mm VaS, anchored by 0 (not at all) and 10 (every time i wanted to communicate), in response to the question [Quote]How much did you use your voice today (including whispering)? i used my voice [?][Quote].
3) Score on neuroticism and extraversion scales of neo-Five Factor inventory.

Participant Eligibility

Males and females
18 years and older
Patients scheduled for vocal fold surgery
Physician order of post-surgical voice rest