Evaluation of the Effects of Adenoidectomy and Adenotonsillectomy on Voice in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Adenoid Hypertrophy, Tonsillar Hypertrophy, Voice Disorders in Children. Basic parameters: 4 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Single-Center Study Evaluating the Effects of Adenoidectomy and Adenotonsillectomy on Voice and Speech Functions in Children
Overview
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.
Primary outcome measures
- Change in Fundamental Frequency (F0) [Time frame: Preoperative, 1 month postoperative, and 3 months postoperative]
- Change in Jitter Percentage [Time frame: Preoperative, 1 month postoperative, and 3 months postoperative]
- Change in Shimmer Percentage [Time frame: 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]
Secondary outcome measures (3)
- Change in Nasalance Scores After Surgery [Time frame: 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]
- Change in Pediatric Voice-Related Quality of Life Scores [Time frame: Preoperative, 1 month postoperative, and 3 months postoperative]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Gaziosmanpaşa Training and Research Hospital — Istanbul
Publications
- 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
Identifiers
NCT: NCT07399041 · ENT-PROS-AD-AT-2026