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

UMIN ID: UMIN000016701

Registered date:06/03/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Vocalcord polyp, vocal nodule
• Date of first enrollment: 2015/02/06
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

In consideration of the vocal hygiene educational program, the speech therapist or main physician should advise the patient in accordance with their lifestyle. Decide the indication of the surgery after 6 months.
Patients are not introduced to the vocal hygiene educational program, and are not advised to change their lifestyle. Decide the indication of the surgery after 6 months.

Outcome(s)

• Primary Outcome: Examining the amount of regression seen in a patient's condition (vocal cord polyp/vocal nodule), after 2 months of outpatient service.
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: National Hospital Organization Japan
• Source(s) of Monetary Support: National Hospital Organization Japan