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).
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Hypofunctional Whispering |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Change in Acoustic Voice Quality Index (AVQI)
Measured: Baseline (preoperative), postoperative month 1, and postoperative month 3
Change in Maximum Phonation Time (MPT)
Measured: Baseline (preoperative), postoperative month 1, and postoperative month 3
Change in s/z ratio
Measured: Baseline (preoperative), postoperative month 1, and postoperative month 3
Change in Auditory-Perceptual Voice Quality Assessed by the CAPE-V Protocol
Measured: Baseline (preoperative), postoperative month 1, and postoperative month 3
Change in Videolaryngostroboscopic Findings Assessed by the VALI Protocol
Measured: 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.
Measured: 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.
Measured: 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.
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.
- First posted15 Jul 2026
- Study start20 Feb 2025
- Primary completion15 Apr 2026
- Study completion2 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Celal Emre Çavlan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Celal Emre Çavlan, Marmara University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effects of Absolute Voice Rest and Hypofunctional Whispering After Phonosurgery
- ClinicalTrials.gov ID
- NCT07704125
- Acronym / sponsor ID
- 09.2023.420
- Keywords
- phonosurgery, microlaryngeal surgery, voice rest, hypofunctional whispering, voice therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Celal Emre ÇavlanUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 2 May 2026 (actual)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absolute Voice Rest | Active comparator | Behavioral: Absolute Voice RestPatients 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. |
| Hypofunctional Whispering | Experimental | Behavioral: Hypofunctional WhisperingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absolute Voice RestComplete voice rest (total silence) for five days after phonosurgery, followed by standardized voice therapy from day six. | Behavioural | Absolute Voice Rest |
| Hypofunctional WhisperingSoft, low-effort (hypofunctional) whispering for five days after phonosurgery, followed by standardized voice therapy from day six. | Behavioural | Hypofunctional Whispering |
Primary outcome
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.
9 secondary outcomes
Change in Acoustic Voice Quality Index (AVQI)
Time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3
Change in Acoustic Voice Quality Index (AVQI)
Time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3
Change in Maximum Phonation Time (MPT)
Time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3
Change in s/z ratio
Time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3
Change in Auditory-Perceptual Voice Quality Assessed by the CAPE-V Protocol
Time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3
Change in Videolaryngostroboscopic Findings Assessed by the VALI Protocol
Time frame: Baseline (preoperative), postoperative month 1, and postoperative month 3
Protocol Compliance Assessed by Visual Analog Scale (VAS)
Time frame: End of the five-day postoperative protocol period (postoperative day 5)
Quality of Life Impact Assessed by Visual Analog Scale (VAS)
Time frame: End of the five-day postoperative protocol period (postoperative day 5)
Patient Satisfaction Assessed by Visual Analog Scale (VAS)
Time frame: End of the five-day postoperative protocol period (postoperative day 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.