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Completed
NCT07704125
Voice Rest Versus Hypofunctional Whispering After Phonosurgery
Conditions: Dysphonia, Vocal Cord Cyst, Vocal Cord Polyp, Bening Vocal Cord Lesions, Reinke Edema
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 16
Sponsor: Celal Emre Çavlan
Location: Marmara University School of Medicine, Department of Otorhinolaryngology - Head and Neck Surgery Istanbul Istanbul
Summary
This randomized controlled trial compares two postoperative voice behavior protocols in patients undergoing microlaryngeal surgery (phonosurgery) for benign vocal fold lesions such as polyps, cysts, and Reinke's edema. After surgery, patients often need to rest their voice while the vocal folds heal. Traditionally, patients are advised to observe absolute voice rest (complete silence) for several days. However, complete silence can be difficult to maintain and may cause psychological and social burden.
The purpose of this study is to find out whether a five-day period of hypofunctional (soft, low-effort) whispering is as safe and effective as five days of absolute voice rest after phonosurgery. Patients were randomly assigned to one of two groups: absolute voice rest or hypofunctional whispering, for the first five days after surgery. From day six onward, both groups received the same standardized voice therapy delivered by a speech-language pathologist.
Patients were evaluated before surgery and again at one month and three months after surgery. The main measure was the change in the Voice Handicap Index-30 (VHI-30), a patient-reported questionnaire about the impact of voice problems on daily life. Additional measures included voice-related quality of life, acoustic voice analysis, aerodynamic measurements, perceptual voice ratings, and videolaryngostroboscopic examination of the vocal folds. The study also assessed protocol compliance, quality of life, and patient satisfaction during the five-day protocol period
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older
* Diagnosis of a benign vocal fold lesion (vocal fold polyp, cyst, or Reinke's edema)
* Scheduled for microlaryngeal (phonosurgery) surgery under general anesthesia
* Able to complete voice assessments and comply with the assigned postoperative voice behavior protocol
* Provided written informed consent
Exclusion Criteria:
* Malignant or premalignant vocal fold lesions
* Previous laryngeal surgery or radiotherapy to the head and neck
* Neurological voice disorders (e.g., vocal fold paralysis, spasmodic dysphonia)
* Significant psychiatric or cognitive impairment preventing protocol compliance
* Active smoking without cessation in Reinke's edema cases where required (if applicable)
* Inability or unwillingness to attend follow-up assessments
Source: ClinicalTrials.gov (NCT07704125). StuddyBuddy aggregates publicly available trial information.