Vocal Cord Dysfunction Clinical Trial
Official title:
Is Voice Rest Contributes to the Quality of Voice After Surgery to Remove Benign Vocal Cord Lesion?
NCT number | NCT03046706 |
Other study ID # | M.P |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 20, 2017 |
Est. completion date | February 1, 2019 |
Verified date | March 2020 |
Source | Rambam Health Care Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The accepted recommendation after removal of vocal cord lesion is voice rest.This recommendation leads to great tension among the patients, loss of working days and need to practice speech therapy.The investigators hypothesize that voice rest after surgery does not affect the quality of the patient's voice. The investigators will divide the patients into 2 groups: the first group will be instructed for a postoperative voice rest and the second group will not. Later the investigators will compare the results and conclude whether voice rest had any significance.
Status | Completed |
Enrollment | 100 |
Est. completion date | February 1, 2019 |
Est. primary completion date | February 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Patient Over 18 years old suffers a benign vocal cord lesion and candidate for surgical removal . Recruitment will take place in the voice and Swallowing Clinic. Rambam medical center. Israel. Exclusion Criteria: - A patient under 18. - Demented patient. - Deaf patient. |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam medical center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
Behrman A, Sulica L. Voice rest after microlaryngoscopy: current opinion and practice. Laryngoscope. 2003 Dec;113(12):2182-6. — View Citation
Ishikawa K, Thibeault S. Voice rest versus exercise: a review of the literature. J Voice. 2010 Jul;24(4):379-87. doi: 10.1016/j.jvoice.2008.10.011. Epub 2009 Aug 5. Review. — View Citation
J. A. Koufman, P.D Blalock. Is voice rest never indicated? J. voice Vol 3, No. 1 87-91
Kaneko M, Shiromoto O, Fujiu-Kurachi M, Kishimoto Y, Tateya I, Hirano S. Optimal Duration for Voice Rest After Vocal Fold Surgery: Randomized Controlled Clinical Study. J Voice. 2017 Jan;31(1):97-103. doi: 10.1016/j.jvoice.2016.02.009. Epub 2016 Aug 1. — View Citation
Kiagiadaki D, Remacle M, Lawson G, Bachy V, Van der Vorst S. The effect of voice rest on the outcome of phonosurgery for benign laryngeal lesions: preliminary results of a prospective randomized study. Ann Otol Rhinol Laryngol. 2015 May;124(5):407-12. doi: 10.1177/0003489414560583. Epub 2014 Nov 20. — View Citation
Rousseau B, Gutmann ML, Mau T, Francis DO, Johnson JP, Novaleski CK, Vinson KN, Garrett CG. Randomized controlled trial of supplemental augmentative and alternative communication versus voice rest alone after phonomicrosurgery. Otolaryngol Head Neck Surg. 2015 Mar;152(3):494-500. doi: 10.1177/0194599814566601. Epub 2015 Jan 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient's evaluation of his own voice | VHI questionnaire score | 1 month post operative | |
Primary | Patient's evaluation of his own voice | VHI questionnaire score | 3 months post operative | |
Primary | Patient's evaluation of his own voice | VHI questionnaire score | 6 months post operative | |
Primary | doctors evaluation of the patient's voice | GRABS scale score | 1 month post operative | |
Primary | doctors evaluation of the patient's voice | GRABS scale score | 3 month post operative | |
Primary | doctors evaluation of the patient's voice | GRABS scale score | 6 month post operative | |
Primary | voice analysis by a software | jitter score, shrimmer score, harmonic to noise ration | 1 month post operative | |
Primary | voice analysis by a software | jitter score, shrimmer score, harmonic to noise ration | 3 month ost operative | |
Primary | voice analysis by a software | jitter score, shrimmer score, harmonic to noise ration | 6 month post operative | |
Secondary | Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web) | The next parameters will be evaluated in each visit: 1. edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value. |
3 days post operative | |
Secondary | Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web) | The next parameters will be evaluated in each visit: 1. edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value. |
2 weeks post operative | |
Secondary | Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web) | The next parameters will be evaluated in each visit: 1. edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value. |
1 month post operative | |
Secondary | Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web) | The next parameters will be evaluated in each visit: 1. edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value. |
3 month post operative | |
Secondary | Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web) | The next parameters will be evaluated in each visit: 1. edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value. |
6 month post operative |
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