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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Change in Fundamental Frequency (F0) [Срок оценки: Preoperative, 1 month postoperative, and 3 months postoperative]
• Change in Jitter Percentage [Срок оценки: Preoperative, 1 month postoperative, and 3 months postoperative]
• Change in Shimmer Percentage [Срок оценки: Preoperative, 1 month postoperative, and 3 months postoperative]
• Change in Harmonics-to-Noise Ratio (HNR) [Срок оценки: Preoperative, 1 month postoperative, and 3 months postoperative]

Вторичные конечные точки (3)

• Change in Nasalance Scores After Surgery [Срок оценки: Preoperative, 1 month postoperative, and 3 months postoperative]
• Change in Pediatric Voice Handicap Index Scores [Срок оценки: Preoperative, 1 month postoperative, and 3 months postoperative]
• Change in Pediatric Voice-Related Quality of Life Scores [Срок оценки: Preoperative, 1 month postoperative, and 3 months postoperative]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Gaziosmanpaşa Training and Research Hospital — Istanbul

Публикации

• Kara M, Ozturk K, Ozer B. An evaluation of the effects of adenoidectomy on voice and speech function in children. Kulak Burun Bogaz Ihtis Derg. 2013 Jul-Aug;23(4):225-31. doi: 10.5606/kbbihtisas.2013.09476. PMID 23834133
• Adenotonsillektominin Akustik, Algısal ve Aerodinamik Ses Parametrelerine Etkisi. Beyhan Yılmaz, Engin Sengul, Musa Özbay, Salih Bakır. Dicle Tıp Dergisi /Dicle Medical Journal 2016; 43 (2): 333-338. doi: 10.5798/diclemedj.0921.2016.02.0691
• Inja RR, Paul RR, Varghese L, Santosh S, Sebastian T, Mathews SS. Voice Change Following Adenotonsillectomy in Pediatric Population: Myth or Reality?-A Pilot Study. Indian J Otolaryngol Head Neck Surg. 2019 Oct;71(Suppl 1):574-579. doi: 10.1007/s12070-018-1412-6. Epub 2018 Jun 4. PMID 31742023

Идентификаторы

NCT: NCT07399041 · ENT-PROS-AD-AT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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