Maternal Voice Versus White Noise in Pediatric Surgery
22 agosto 2026 aggiornato da: Sinem Öztürkler, Kocaeli University
Maternal Voice Versus White Noise: Effects on Pain, Comfort, and Physiological Responses in Pediatric Surgery
This randomized controlled study will evaluate the effects of maternal voice and white noise on postoperative pain, comfort, and physiological parameters in children aged 1 month to 3 years during the early postoperative period.
The study will also compare the effectiveness of maternal voice and white noise in improving these outcomes.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
For the maternal voice intervention, the mother will select a lullaby, and its lyrics will be provided to her by the researcher. The lullaby will be recorded in the mother's voice with the assistance of the researcher. The sound level of the recording will be adjusted to approximately 50 decibels. Children assigned to the maternal voice group will listen to the recorded lullaby during the early postoperative period. A copy of the recording will be provided to the mother after completion of the study.
Children assigned to the white noise group will listen to the white noise recording "Don't Let Your Baby Cry 2" from the album "Colic." The recording includes intrauterine-like and white-noise sounds combined with music. The recording will be used after obtaining the necessary permissions from the relevant copyright holders.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
90
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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İ̇zmi̇t
-
Kocaeli, İ̇zmi̇t, Turchia (Türkiye)
- Kocaeli University
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Aged 1 to 3 years
- Scheduled to undergo an elective minor surgical procedure, such as orchiopexy, hypospadias repair, or hernia repair
- Undergoing surgery under general anesthesia with an anesthesia duration not exceeding 60 minutes
- No known hearing impairment
- No anatomical abnormality of the ear
- No chronic condition that could affect auditory perception or pain response, such as cerebral palsy, Down syndrome, or another neurodevelopmental disorder
- Scheduled for direct transfer to the pediatric surgery ward after surgery without an extended stay in the postanesthesia care unit
- Written informed consent provided by a parent or legal guardian
Exclusion Criteria:
- Surgery performed under emergency conditions
- A surgical procedure different from the planned procedure
- Anesthesia duration exceeding 60 minutes
- Development of a postoperative complication requiring admission to the postanesthesia care unit or intensive care unit
- Administration of additional analgesic medication beyond the institutional analgesia protocol
- Interruption or inability to complete the 60-minute auditory intervention or observation period
- Withdrawal of consent by the parent or legal guardian
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Maternal voice
Children received routine postoperative nursing care and listened continuously for 60 minutes to a preoperatively recorded lullaby sung by their mother.
Playback began after baseline physiological measurements following admission to the pediatric surgery ward.
The recording was played through a portable speaker positioned at the head of the child's bed at ear level, with the sound intensity maintained at 50-55 decibels.
|
Before surgery, each mother selected and recorded a lullaby in a quiet room with guidance from the researcher.
Following postoperative admission to the pediatric surgery ward, the recording was played continuously to the child for 60 minutes through a portable speaker.
Sound intensity was monitored using a calibrated sound-level meter and maintained at 50-55 decibels.
|
|
Sperimentale: White noise
Children received routine postoperative nursing care and listened continuously to a standardized white noise recording for 60 minutes.
Playback began after baseline physiological measurements following admission to the pediatric surgery ward.
The recording was played through a portable speaker positioned at the head of the child's bed at ear level, with the sound intensity maintained at 50-55 decibels.
|
Children listened to the standardized recording "Don't Let Your Baby Cry 2" from the album "Colic."
The recording included intrauterine-like sounds, white-noise frequency components, and accompanying music.
It was played continuously for 60 minutes through a portable speaker.
Sound intensity was monitored using a calibrated sound-level meter and maintained at 50-55 decibels.
|
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Nessun intervento: Control Arm
Children received routine postoperative nursing care without a structured auditory intervention.
No planned silence or sound restriction was imposed, and the children remained in the usual auditory environment of the pediatric surgery ward.
Outcome assessments were conducted at the same time points as in the intervention groups.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Postoperative Pain Assessed Using the Face, Legs, Activity, Cry, and Consolability Scale
Lasso di tempo: 30 and 60 minutes after admission to the pediatric surgery ward
|
Postoperative pain was assessed using the Face, Legs, Activity, Cry, and Consolability Scale.
The scale evaluates five behavioral domains: facial expression, leg movement, activity, crying, and consolability.
Each domain is scored from 0 to 2, producing a total score ranging from 0 to 10. Higher scores indicate greater postoperative pain and therefore a worse outcome.
The scale was administered at 30 and 60 minutes.
The prespecified primary endpoint was the total score at 60 minutes.
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30 and 60 minutes after admission to the pediatric surgery ward
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Postoperative Recovery Assessed Using the Modified Aldrete Recovery Score
Lasso di tempo: 30 and 60 minutes after admission to the pediatric surgery ward
|
Postoperative recovery was assessed using the Modified Aldrete Recovery Score.
The scale evaluates five domains: motor activity, respiration, circulation, consciousness, and peripheral oxygen saturation.
Each domain is scored from 0 to 2, producing a total score ranging from 0 to 10. Higher scores indicate a better level of postoperative recovery.
A score of 9 or higher generally indicates readiness for discharge from postanesthesia care.
The scale was administered at 30 and 60 minutes.
The prespecified secondary endpoint was the total score at 60 minutes.
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30 and 60 minutes after admission to the pediatric surgery ward
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Heart Rate
Lasso di tempo: Immediately after admission and before the intervention, and at 30 and 60 minutes
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Heart rate was measured using a pulse oximeter and recorded as beats per minute.
Lower values within the age-appropriate physiological range indicate reduced physiological arousal; however, the measure does not have a predefined better or worse direction independently of the clinical context.
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Immediately after admission and before the intervention, and at 30 and 60 minutes
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Respiratory Rate
Lasso di tempo: Immediately after admission and before the intervention, and at 30 and 60 minutes
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Respiratory rate was recorded as breaths per minute.
Lower values within the age-appropriate physiological range may indicate reduced physiological arousal; however, the measure does not have a predefined better or worse direction independently of the clinical context.
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Immediately after admission and before the intervention, and at 30 and 60 minutes
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Peripheral Oxygen Saturation
Lasso di tempo: Immediately after admission and before the intervention, and at 30 and 60 minutes
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Peripheral oxygen saturation was measured using a pulse oximeter and recorded as a percentage.
Higher values within the clinically expected range indicate better oxygenation.
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Immediately after admission and before the intervention, and at 30 and 60 minutes
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 gennaio 2024
Completamento primario (Effettivo)
1 gennaio 2025
Completamento dello studio (Effettivo)
1 gennaio 2026
Date di iscrizione allo studio
Primo inviato
16 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
22 agosto 2026
Primo Inserito (Effettivo)
25 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2023/361
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .