Voice Rest Versus Hypofunctional Whispering After Phonosurgery

NCT07704125 | Completed

• 1 other identifier: 09.2023.420
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dysphonia; Vocal Cord Cyst; Vocal Cord Polyp; Bening Vocal Cord Lesions; Reinke Edema

Keywords

phonosurgery; microlaryngeal surgery; voice rest; hypofunctional whispering; voice therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Acoustic Voice Quality Index (AVQI)

  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

Study Arms (2)

Absolute Voice Rest

ACTIVE COMPARATOR

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

Hypofunctional Whispering

EXPERIMENTAL

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

Interventions

Absolute Voice Rest BEHAVIORAL

Complete voice rest (total silence) for five days after phonosurgery, followed by standardized voice therapy from day six.

Absolute Voice Rest

Hypofunctional Whispering BEHAVIORAL

Soft, low-effort (hypofunctional) whispering for five days after phonosurgery, followed by standardized voice therapy from day six.

Hypofunctional Whispering

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celal Emre Çavlan: lead

Study Sites (1)

Marmara University School of Medicine, Department of Otorhinolaryngology - Head and Neck Surgery

Istanbul, Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Fellow, Department of Otorhinolaryngology, Marmara University

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 15, 2026
• Study Start: February 20, 2025
• Primary Completion: April 15, 2026
• Study Completion: May 2, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)