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DysphoniaNCT07704125

Voice Rest Versus Hypofunctional Whispering After Phonosurgery

A study testing Absolute Voice Rest and Hypofunctional Whispering in people with Dysphonia and Vocal Cord Cyst, run by Celal Emre Çavlan at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dysphonia, Vocal Cord Cyst, Vocal Cord Polyp
What is being tested?
Absolute Voice Rest and Hypofunctional Whispering
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Feb 2025to 2 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara University School of Medicine, Department of Otorhinolaryngology - Head and Neck Surgery

    Istanbul, Istanbul, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Read the 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.

Being tested
Absolute Voice Rest, Hypofunctional Whispering
Keywords
phonosurgery, microlaryngeal surgery, voice rest, hypofunctional whispering, voice therapy
Medical subject headings
Dysphonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Absolute Voice RestBehavioural

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

  • Hypofunctional WhisperingBehavioural

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

Study groups in NCT07704125
Study groupRoleWhat they receive
Absolute Voice RestActive comparatorPatients 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.
Receives: Behavioral: Absolute Voice Rest
Hypofunctional WhisperingExperimentalPatients 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.
Receives: Behavioral: Hypofunctional Whispering

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (preoperative), postoperative month 1, and postoperative month 3

Secondary outcomes (9)
  1. 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.

    Measured: Baseline (preoperative), postoperative month 1, and postoperative month 3

  2. Change in Acoustic Voice Quality Index (AVQI)

    Measured: Baseline (preoperative), postoperative month 1, and postoperative month 3

  3. Change in Maximum Phonation Time (MPT)

    Measured: Baseline (preoperative), postoperative month 1, and postoperative month 3

  4. Change in s/z ratio

    Measured: Baseline (preoperative), postoperative month 1, and postoperative month 3

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

    Measured: Baseline (preoperative), postoperative month 1, and postoperative month 3

  6. Change in Videolaryngostroboscopic Findings Assessed by the VALI Protocol

    Measured: Baseline (preoperative), postoperative month 1, and postoperative month 3

  7. 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.

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

  8. 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.

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

  9. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start20 Feb 2025
  3. Primary completion15 Apr 2026
  4. Study completion2 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07704125
Sponsor's protocol ID
09.2023.420
Status last verified
Jul 2026
First submitted
8 Jul 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Absolute Voice Rest and Hypofunctional Whispering in people with Dysphonia and Vocal Cord Cyst, run by Celal Emre Çavlan at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Voice Handicap Index-30 (VHI-30) total score (time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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