Voice Rest Versus Hypofunctional Whispering After Phonosurgery

The Clinical Effects of Absolute Voice Rest and Hypofunctional Whispering After Phonosurgery

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

Study Overview

• Status: Completed
• Conditions: Dysphonia; Vocal Cord Cyst; Vocal Cord Polyp; Bening Vocal Cord Lesions; Reinke Edema
• Intervention / Treatment: Behavioral: Absolute Voice Rest; Behavioral: Hypofunctional Whispering

Detailed Description

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.

Interventions: All patients underwent suspension microlaryngoscopy under general anesthesia by a single surgeon, using a microflap technique with preservation of the superficial layer of the lamina propria. Group 1 observed absolute voice rest for five postoperative days; Group 2 followed a hypofunctional whispering protocol (soft, low-effort whispering) for five postoperative days. From postoperative day six onward, both groups received the same standardized voice therapy protocol delivered by an experienced speech-language pathologist.

Outcome Measures: The primary outcome was the change in Voice Handicap Index-30 (VHI-30) total score from baseline to postoperative month 3, with the established minimal clinically important difference (MCID) of 18 points used as a reference. Secondary outcomes included Voice-Related Quality of Life (V-RQOL), Acoustic Voice Quality Index (AVQI) and traditional acoustic parameters (F0, jitter, shimmer, HNR), aerodynamic measurements (maximum phonation time and s/z ratio), perceptual evaluation according to the CAPE-V protocol, and videolaryngostroboscopic findings scored with the VALI protocol. All assessments were performed at three time points: preoperatively, postoperative month 1, and postoperative month 3. At the end of the five-day protocol period, patients completed a structured questionnaire assessing protocol compliance, quality of life, and satisfaction.

Statistical Analysis: Between-group and within-time comparisons were performed using linear mixed model analysis, with time, group, and time-by-group interaction as fixed effects and patient as a random effect. The difference between the two protocols was assessed via the significance of the time-by-group interaction term. Questionnaire comparisons were analyzed using Mann-Whitney U and Fisher exact tests. The proportion of patients exceeding the VHI-30 MCID threshold was compared using the chi-square test.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34854
      • Marmara University School of Medicine, Department of Otorhinolaryngology - Head and Neck Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Absolute Voice Rest; Patients observed absolute voice rest (complete silence) for the first five postoperative days. From postoperative day six, they received a standardized voice therapy protocol delivered by a speech-language pathologist.	Behavioral: Absolute Voice Rest; Complete voice rest (total silence) for five days after phonosurgery, followed by standardized voice therapy from day six.
Experimental: Hypofunctional Whispering; Patients used a hypofunctional whispering protocol (soft, low-effort whispering) for the first five postoperative days. From postoperative day six, they received the same standardized voice therapy protocol delivered by a speech-language pathologist.	Behavioral: Hypofunctional Whispering; Soft, low-effort (hypofunctional) whispering for five days after phonosurgery, followed by standardized voice therapy from day six.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Voice Handicap Index-30 (VHI-30) total score	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.	Baseline (preoperative), postoperative month 1, and postoperative month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Acoustic Voice Quality Index (AVQI)	The Acoustic Voice Quality Index (AVQI) is a multiparametric acoustic measure combining several acoustic parameters into a single score reflecting overall voice quality; higher values indicate more severe dysphonia. Calculated using Praat software.	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
Change in Videolaryngostroboscopic Findings Assessed by the VALI Protocol		Baseline (preoperative), postoperative month 1, and postoperative month 3
Protocol Compliance Assessed by Visual Analog Scale (VAS)	Self-reported protocol compliance measured with a study-specific (non-validated) structured questionnaire. Scores range from 0 to 100; higher scores indicate better compliance.	End of the five-day postoperative protocol period (postoperative day 5)
Quality of Life Impact Assessed by Visual Analog Scale (VAS)	Impact on quality of life measured with a study-specific (non-validated) structured questionnaire covering general wellbeing, family communication, social life, occupational life, and psychological impact. Scores range from 0 to 100; higher scores indicate greater (worse) impact.	End of the five-day postoperative protocol period (postoperative day 5)
Patient Satisfaction Assessed by Visual Analog Scale (VAS)	Patient satisfaction with the assigned voice behavior protocol measured with a study-specific (non-validated) structured questionnaire. Scores range from 0 to 100; higher scores indicate greater satisfaction.	End of the five-day postoperative protocol period (postoperative day 5)

Collaborators and Investigators

• Sponsor: Celal Emre Çavlan

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Actual): April 15, 2026
• Study Completion (Actual): May 2, 2026

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: voice rest; voice therapy; phonosurgery; microlaryngeal surgery; hypofunctional whispering
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Voice Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dysphonia
• Other Study ID Numbers: 09.2023.420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No