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Not Yet RecruitingNCT07399041

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

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
36 (estimated)
Sponsor
Gaziosmanpasa Research and Education Hospital · Other Government
Sex
All
Age
4 Years – 13 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Timeline

Start date
2026-02-01
Primary completion
2026-07-01
Completion
2026-08-01
First posted
2026-02-10
Last updated
2026-02-10

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07399041. Inclusion in this directory is not an endorsement.