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Completed

NCT Number: NCT07704125

Voice Rest Versus 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Absolute Voice Rest

Behavioral

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

Hypofunctional Whispering

Behavioral

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

Primary outcomes

  1. Change in Voice Handicap Index-30 (VHI-30) total score

    Time frame: 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.

Secondary outcomes

  1. Change in Acoustic Voice Quality Index (AVQI)

    Time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3

    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.

  2. Change in Acoustic Voice Quality Index (AVQI)

    Time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3

  3. Change in Maximum Phonation Time (MPT)

    Time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3

  4. Change in s/z ratio

    Time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3

  5. Change in Auditory-Perceptual Voice Quality Assessed by the CAPE-V Protocol

    Time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3

  6. Change in Videolaryngostroboscopic Findings Assessed by the VALI Protocol

    Time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3

  7. Protocol Compliance Assessed by Visual Analog Scale (VAS)

    Time frame: End of the five-day postoperative protocol period (postoperative day 5)

    Self-reported protocol compliance measured with a study-specific (non-validated) structured questionnaire. Scores range from 0 to 100; higher scores indicate better compliance.

  8. Quality of Life Impact Assessed by Visual Analog Scale (VAS)

    Time frame: End of the five-day postoperative protocol period (postoperative day 5)

    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.

  9. Patient Satisfaction Assessed by Visual Analog Scale (VAS)

    Time frame: End of the five-day postoperative protocol period (postoperative day 5)

    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.

Sponsors and collaborators

Lead sponsor

Celal Emre Çavlan

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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