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NCT01255735 · ClinicalTrials.gov registry record
Randomized Controlled Trial of Voice on Children With Vocal Nodules
A clinical trial of Vocal Fold Nodules, sponsored by Massachusetts Eye and Ear Infirmary.
- Completed
- Registry status
- 114
- Enrollment target
- 4
- Study locations
NCT01255735: Completed study of Vocal Fold Nodules, sponsored by Massachusetts Eye and Ear Infirmary.
NCT01255735 is a study of Vocal Fold Nodules that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 114 participants, above the 27-participant average among 3 other Vocal Fold Nodules trials with a reported enrollment target (322% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01255735, a study of Vocal Fold Nodules, has completed, sponsored by Massachusetts Eye and Ear Infirmary.
- COMPLETED
- Registry status
- 114 participants
- Enrollment target
- 4
- Study locations
Study Summary
The primary objective of this study is to determine the impact of voice therapy on voice-related quality of life in children age 6-10 years old with apparent vocal fold nodules, as measured by the validated Pediatric Voice-Related Quality of Life Instrument (PVRQOL)administered 4 weeks after completion of voice therapy.
Primary Outcome
The PVRQOL consists of 10 questions completed by parent proxy administration that requires approximately 5 minutes to complete. It measures the parent's assessment of their child's overall quality of life as related to their vocal condition.
Conditions Studied
Study Locations (4)
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
Pennsylvania
- Drexell University College of Medicine - Philadelphia
Wisconsin
- Children's Hospital of Wisconsin - Milwaukee
Ontario
- The Hospital For Sick Children - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-11 |
What the finished NCT01255735 record still lists
NCT01255735 is an observational study that tracks outcomes without assigning an intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, above the 27-participant average among 3 other Vocal Fold Nodules trials with a reported enrollment target (322% higher).
The record links to 1 condition, with Vocal Fold Nodules appearing as the primary indexed condition, and to 0 interventions.
NCT01255735 reports a single indexed study location in Massachusetts, Pennsylvania, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01255735 about?
NCT01255735 is a clinical study titled "Randomized Controlled Trial of Voice on Children With Vocal Nodules". The primary objective of this study is to determine the impact of voice therapy on voice-related quality of life in children age 6-10 years old with apparent vocal fold nodules, as measured by the validated Pediatric Voice-Related Quality of Life Instrument (PVRQOL)administered 4 weeks after complet...
What is the current status of trial NCT01255735?
This trial is currently completed. The enrollment target is 114 participants. The study started on 2011-01. Estimated completion is 2016-11.
What conditions does trial NCT01255735 study?
This clinical trial studies the following conditions: Vocal Fold Nodules.
Who is sponsoring clinical trial NCT01255735?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01255735 being conducted?
This trial has 4 study locations across Massachusetts, Pennsylvania, Wisconsin, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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