To validate the efficiency of patient-centered noninvasive conservative treatment of vocal cord polyp and/or vocal nodule achieved by vocal hygiene education.

Not Applicable

• Conditions: Vocalcord polyp, vocal nodule

• Registration Number: JPRN-UMIN000016701
• Lead Sponsor: ational Hospital Organization Japan

Brief Summary

Hosoya M, Kobayashi R, Ishii T, Senarita M, Kuroda H, Misawa H, Tanaka F, Takiguchi T, Tashiro M, Masuda S, Hashimoto S, Goto F, Minami S, Yamamoto N, Nagai R, Sayama A, Wakabayashi T, Toshikuni K, Ueha R, Fujimaki Y, Takazawa M, Sekimoto S, Itoh K, Nito T, Kada A, Tsunoda K. Vocal Hygiene Education Program Reduces Surgical Interventions for Benign Vocal Fold Lesions: A Randomized Controlled Trial. Laryngoscope. 2018 Nov;128(11):2593-2599. doi: 10.1002/lary.27415.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-06
• Study Completion: 2017-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1. Laryngeal examination (fiberscopic and/or stroboscopic study, etc.) suggests laryngeal cancer. 2. Laryngeal examination (fiberscopic and/or stroboscopic study, etc.) suggests laryngeal granuloma. 3. Laryngeal examination (fiberscopic and/or stroboscopic study, etc.) suggests tuberculosis. 4. Laryngeal examination (fiberscopic and/or stroboscopic study, etc.) suggests collagen disease. 5. Laryngeal examination (fiberscopic and/or stroboscopic study, etc.) suggests laryngeal cyst. 6. Laryngeal examination (fiberscopic and/or stroboscopic study, etc.) suggests Reinke's edema. 7. Patients who need surgery within 2 months. 8. Patients denied participation by their physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Examining the amount of regression seen in a patient's condition (vocal cord polyp/vocal nodule), after 2 months of outpatient service.

Secondary Outcome Measures

Name	Time	Method
Change in condition (the presence or absence of glottal/ membrane fluctuation), objective voice evaluation (GRBAS, phonetic function test, MPT), change in patients subjective satisfaction (VHI), adverse event