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Clinical Trials/NCT07399041
NCT07399041
Not yet recruiting
Not Applicable

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

Gaziosmanpasa Research and Education Hospital1 site in 1 country36 target enrollmentStarted: February 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
36
Locations
1
Primary Endpoint
Change in Fundamental Frequency (F0)

Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
4 Years to 13 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

  • Change in Nasalance Scores After Surgery(Preoperative, 1 month postoperative, and 3 months postoperative)
  • Change in Pediatric Voice Handicap Index Scores(Preoperative, 1 month postoperative, and 3 months postoperative)
  • Change in Pediatric Voice-Related Quality of Life Scores(Preoperative, 1 month postoperative, and 3 months postoperative)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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