Evaluation of the Effects of Adenoidectomy and Adenotonsillectomy on Voice in Children

February 2, 2026 updated by: Gaziosmanpasa Research and Education Hospital

A Prospective Single-Center Study Evaluating the Effects of Adenoidectomy and Adenotonsillectomy on Voice and Speech Functions in Children

This prospective study aims to evaluate the effects of adenoidectomy and adenotonsillectomy on voice and speech functions in children. Changes in voice quality and resonance may occur after the removal of adenoid and tonsillar tissues, particularly in pediatric patients with enlarged adenoids or tonsils.

Objective voice assessments, including acoustic, aerodynamic, and nasalance measurements, as well as subjective voice-related quality of life questionnaires, will be performed before surgery and at the first and third months after surgery. The results of this study are expected to help clinicians better inform families about possible voice changes following adenoidectomy and adenotonsillectomy procedures.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This is a prospective, single-center observational study designed to evaluate the effects of adenoidectomy and adenotonsillectomy on voice and speech functions in pediatric patients.

A minimum of 36 children aged between 4 and 13 years who are scheduled for primary adenoidectomy or adenotonsillectomy will be included in the study. Written informed consent will be obtained from the parents or legal guardians of all participants prior to enrollment. All patients will undergo routine otolaryngological examination.

Voice recordings will be obtained in a sound-isolated room one day before surgery and at the first and third postoperative months. Recordings will be performed using an AKG P5-S dynamic microphone (AKG®, Vienna, Austria) and a Behringer UMC22 audio interface (Behringer®, Willich, Germany). The microphone will be positioned at approximately a 90-degree angle and 10 cm from the mouth while the patient is seated.

Participants will be instructed to sustain the vowel /a/ at a comfortable pitch and loudness following deep inspiration, repeated three times. The longest sustained phonation will be recorded as the maximum phonation time and used as an aerodynamic parameter.

Acoustic analysis will be performed using Praat software (Version 6.1.39; Paul Boersma and David Weenink, University of Amsterdam). Sustained vowel samples of 3-5 seconds will be analyzed to obtain fundamental frequency (F0), jitter, shimmer, and harmonics-to-noise ratio (HNR) values.

Nasalance measurements will be conducted using a Plex device and a dynamic microphone to evaluate nasal resonance and determine whether resonance values fall within normal limits.

All voice recordings will be captured using Audacity software and analyzed using Praat. Subjective voice assessment will be performed using the Pediatric Voice Handicap Index and the Pediatric Voice-Related Quality of Life questionnaires, both of which have been validated in Turkish. These questionnaires will be administered preoperatively and at the first and third postoperative months.

The study aims to provide objective and subjective data regarding voice changes following adenoidectomy and adenotonsillectomy and to support preoperative counseling of families regarding potential postoperative voice outcomes.

Study Type

Observational

Enrollment (Estimated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study includes children aged 4-13 years who are scheduled for primary adenoidectomy or adenotonsillectomy. The aim is to evaluate the effects of these surgical procedures on voice and speech function, using both objective acoustic measurements and validated pediatric voice-related quality of life questionnaires.

Description

Inclusion Criteria:

  • Aged 4-13 years
  • Scheduled for primary adenoidectomy or adenotonsillectomy

Exclusion Criteria:

  • Does not meet inclusion criteria
  • Refuses to participate in the study
  • Diagnosis of vocal cord disorders
  • History of vocal cord surgery
  • History of cleft palate or cleft lip
  • Hearing loss requiring a hearing aid
  • Chronic diseases that may impair wound healing, including: hypertension, diabetes mellitus, immunodeficiency, autoimmune diseases, rheumatologic diseases, connective tissue disorders, renal failure, liver failure, chronic heart disease
  • Known bleeding diathesis
  • Use of anticoagulant or antiplatelet drugs
  • Upper respiratory tract infection within the last 2 weeks
  • Patients undergoing revision adenoidectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children Undergoing Adenoidectomy or Adenotonsillectomy
Children aged 4-13 years scheduled for routine adenoidectomy or adenotonsillectomy. Participants are followed prospectively to evaluate changes in voice and speech parameters before surgery and at postoperative 1st and 3rd months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fundamental Frequency (F0)
Time Frame: Preoperative, 1 month postoperative, and 3 months postoperative
Fundamental frequency (F0), expressed in Hertz (Hz), will be measured using objective acoustic voice analysis with Praat software. Measurements will be obtained from sustained vowel /a/ recordings and compared between preoperative and postoperative evaluations.
Preoperative, 1 month postoperative, and 3 months postoperative
Change in Jitter Percentage
Time Frame: Preoperative, 1 month postoperative, and 3 months postoperative
Jitter, expressed as a percentage (%), will be measured from sustained vowel /a/ recordings using Praat software. Preoperative jitter values will be compared with postoperative measurements at the 1st and 3rd months to assess changes in frequency stability after surgery.
Preoperative, 1 month postoperative, and 3 months postoperative
Change in Shimmer Percentage
Time Frame: Preoperative, 1 month postoperative, and 3 months postoperative
Shimmer, expressed as a percentage (%), will be measured from sustained vowel /a/ recordings using Praat software. Measurements obtained preoperatively will be compared with postoperative values at the 1st and 3rd months to evaluate changes in amplitude stability following surgery.
Preoperative, 1 month postoperative, and 3 months postoperative
Change in Harmonics-to-Noise Ratio (HNR)
Time Frame: Preoperative, 1 month postoperative, and 3 months postoperative
Harmonics-to-noise ratio (HNR), measured in decibels (dB), will be obtained from sustained vowel /a/ recordings using Praat software. Preoperative and postoperative (1st and 3rd months) values will be compared to assess changes in voice signal quality after surgery.
Preoperative, 1 month postoperative, and 3 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Nasalance Scores After Surgery
Time Frame: Preoperative, 1 month postoperative, and 3 months postoperative
Nasalance will be measured using a nasalance measurement system with a plex device and dynamic microphone. Nasalance scores are expressed as percentages ranging from 0% to 100%, with higher scores indicating increased nasal resonance. Preoperative and postoperative measurements will be compared.
Preoperative, 1 month postoperative, and 3 months postoperative
Change in Pediatric Voice Handicap Index Scores
Time Frame: Preoperative, 1 month postoperative, and 3 months postoperative
Subjective voice outcomes will be assessed using the Pediatric Voice Handicap Index (PVHI). The total score ranges from 0 to 92, with higher scores indicating greater perceived voice-related handicap. The validated Turkish version of the questionnaire will be administered preoperatively and postoperatively.
Preoperative, 1 month postoperative, and 3 months postoperative
Change in Pediatric Voice-Related Quality of Life Scores
Time Frame: Preoperative, 1 month postoperative, and 3 months postoperative
Voice-related quality of life will be evaluated using the Pediatric Voice-Related Quality of Life (PVRQOL) questionnaire. Scores range from 0 to 100, with higher scores indicating better voice-related quality of life. The validated Turkish version will be used.
Preoperative, 1 month postoperative, and 3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziosmanpasa Research and Education Hospital

Investigators

  • Principal Investigator: DERYA CEBECİ, MD, Gaziosmanpaşa Training and Research Hospital, Department of Otolaryngology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ENT-PROS-AD-AT-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) from this study will not be shared outside of the research team due to the sensitive nature of pediatric patient data and privacy considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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