Evaluation of the Effects of Adenoidectomy and Adenotonsillectomy on Voice in Children
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-13
SponsorGaziosmanpasa Research and Education Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 4-13 years
Scheduled for primary adenoidectomy or adenotonsillectomy
Disqualifiers
Does not meet inclusion criteria
Refuses to participate in the study
Diagnosis of vocal cord disorders
History of vocal cord surgery
Trial population
This study includes children aged 4-13 years who are scheduled for primary adenoidectomy or adenotonsillectomy. The aim is to evaluate the effects of these surgical procedures on voice and speech function, using both objective acoustic measurements and validated pediatric voice-related quality of life questionnaires.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
36 Participants
are grouped into 1 trial groupGroup A: Children Undergoing Adenoidectomy or Adenotonsillectomy
Trial outcomes
Primary outcomes
1
Change in Fundamental Frequency (F0)
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.
Time frame
Preoperative, 1 month postoperative, and 3 months postoperative2
Change in Jitter Percentage
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.
Time frame
Preoperative, 1 month postoperative, and 3 months postoperative3
Change in Shimmer Percentage
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.
Time frame
Preoperative, 1 month postoperative, and 3 months postoperative4
Change in Harmonics-to-Noise Ratio (HNR)
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.
Time frame
Preoperative, 1 month postoperative, and 3 months postoperativeSecondary outcomes
1
Change in Nasalance Scores After Surgery
Nasalance will be measured using a nasalance measurement system with a plex device and dynamic microphone. Nasalance scores are expressed as percentages ranging from 0% to 100%, with higher scores indicating increased nasal resonance. Preoperative and postoperative measurements will be compared.
Time frame
Preoperative, 1 month postoperative, and 3 months postoperative2
Change in Pediatric Voice Handicap Index Scores
Subjective voice outcomes will be assessed using the Pediatric Voice Handicap Index (PVHI). The total score ranges from 0 to 92, with higher scores indicating greater perceived voice-related handicap. The validated Turkish version of the questionnaire will be administered preoperatively and postoperatively.
Time frame
Preoperative, 1 month postoperative, and 3 months postoperative3
Change in Pediatric Voice-Related Quality of Life Scores
Voice-related quality of life will be evaluated using the Pediatric Voice-Related Quality of Life (PVRQOL) questionnaire. Scores range from 0 to 100, with higher scores indicating better voice-related quality of life. The validated Turkish version will be used.
Time frame
Preoperative, 1 month postoperative, and 3 months postoperativeSponsors and contacts
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Source ClinicalTrials.gov
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