The Clinical Effects of Absolute Voice Rest and Hypofunctional Whispering After Phonosurgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Voice Handicap Index-30 (VHI-30) total score
研究概览
简要总结
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
详细描述
Background: Benign vocal fold lesions (polyps, cysts, and Reinke's edema) are among the most common organic causes of dysphonia and are frequently treated with microlaryngeal phonosurgery. The optimal postoperative voice behavior protocol remains debated. Absolute voice rest has traditionally been recommended to protect the healing vocal fold mucosa, but growing evidence suggests that its theoretical advantage may not translate into superior clinical outcomes, and complete silence imposes a considerable psychosocial burden. Studies directly comparing hypofunctional whispering with absolute voice rest using a prospective randomized design are limited.
Objective: To compare the effects of two postoperative voice behavior protocols applied for five days after phonosurgery for benign vocal fold lesions - absolute voice rest versus communication limited to hypofunctional whispering - on patient-reported voice outcomes, acoustic parameters, aerodynamic measurements, perceptual evaluation, and videolaryngostroboscopic findings.
Design: Prospective, single-center, randomized, parallel-group controlled trial conducted in the Department of Otorhinolaryngology - Head and Neck Surgery at Marmara University School of Medicine.
Participants: Patients with benign vocal fold lesions (polyp, cyst, or Reinke's edema) scheduled for microlaryngeal surgery who met the inclusion criteria. Sixteen patients were enrolled and analyzed.
Randomization and Blinding: Patients were allocated 1:1 into two groups using computer-based random number generation, performed after preoperative assessment and immediately before surgery. Due to the nature of the intervention, blinding of patients and the surgical team was not possible. However, perceptual (CAPE-V) recordings were rated by two independent speech-language pathologists, and videolaryngostroboscopic recordings by two independent laryngologists, all blinded to group assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Voice Handicap Index-30 (VHI-30) total score
时间窗: Baseline (preoperative), postoperative month 1, and postoperative month 3
The Voice Handicap Index-30 (VHI-30) is a 30-item patient-reported questionnaire assessing the physical, functional, and emotional impact of voice disorders. Total score ranges from 0 to 120, with higher scores indicating greater voice-related handicap. The primary outcome was the change in VHI-30 total score from baseline to postoperative month 3. The established minimal clinically important difference (MCID) of 18 points was used as a reference.
次要结局
- Change in Videolaryngostroboscopic Findings Assessed by the VALI Protocol(Baseline (preoperative), postoperative month 1, and postoperative month 3)
- Change in Acoustic Voice Quality Index (AVQI)(Baseline (preoperative), postoperative month 1, and postoperative month 3)
- Change in Maximum Phonation Time (MPT)(Baseline (preoperative), postoperative month 1, and postoperative month 3)
- Change in s/z ratio(Baseline (preoperative), postoperative month 1, and postoperative month 3)
- Change in Auditory-Perceptual Voice Quality Assessed by the CAPE-V Protocol(Baseline (preoperative), postoperative month 1, and postoperative month 3)
- Protocol Compliance Assessed by Visual Analog Scale (VAS)(End of the five-day postoperative protocol period (postoperative day 5))
- Quality of Life Impact Assessed by Visual Analog Scale (VAS)(End of the five-day postoperative protocol period (postoperative day 5))
- Patient Satisfaction Assessed by Visual Analog Scale (VAS)(End of the five-day postoperative protocol period (postoperative day 5))
研究者
Celal Emre Çavlan
Research Fellow, Department of Otorhinolaryngology, Marmara University
Marmara University