Maternal Voice Versus White Noise in Pediatric Surgery
22. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
90
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
İ̇zmi̇t
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Kocaeli, İ̇zmi̇t, Turecko (Türkiye)
- Kocaeli University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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.
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Experimentální: 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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Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Postoperative Pain Assessed Using the Face, Legs, Activity, Cry, and Consolability Scale
Časové okno: 30 and 60 minutes after admission to the pediatric surgery ward
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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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Postoperative Recovery Assessed Using the Modified Aldrete Recovery Score
Časové okno: 30 and 60 minutes after admission to the pediatric surgery ward
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. ledna 2024
Primární dokončení (Aktuální)
1. ledna 2025
Dokončení studie (Aktuální)
1. ledna 2026
Termíny zápisu do studia
První předloženo
16. června 2026
První předloženo, které splnilo kritéria kontroly kvality
22. srpna 2026
První zveřejněno (Aktuální)
25. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
25. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
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