A Prospective Single-Center Study Evaluating the Effects of Adenoidectomy and Adenotonsillectomy on Voice and Speech Functions in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Fundamental Frequency (F0)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 4-13 years
- •Scheduled for primary adenoidectomy or adenotonsillectomy
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Change in Fundamental Frequency (F0)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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)