Maternal Voice Versus White Noise in Pediatric Surgery
22. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
90
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
İ̇zmi̇t
-
Kocaeli, İ̇zmi̇t, Türkei (türkiye)
- Kocaeli University
-
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Postoperative Pain Assessed Using the Face, Legs, Activity, Cry, and Consolability Scale
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Postoperative Recovery Assessed Using the Modified Aldrete Recovery Score
Zeitfenster: 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
Zeitfenster: Immediately after admission and before the intervention, and at 30 and 60 minutes
|
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
Zeitfenster: Immediately after admission and before the intervention, and at 30 and 60 minutes
|
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.
|
Immediately after admission and before the intervention, and at 30 and 60 minutes
|
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Peripheral Oxygen Saturation
Zeitfenster: Immediately after admission and before the intervention, and at 30 and 60 minutes
|
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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Mitarbeiter und Ermittler
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Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Januar 2024
Primärer Abschluss (Tatsächlich)
1. Januar 2025
Studienabschluss (Tatsächlich)
1. Januar 2026
Studienanmeldedaten
Zuerst eingereicht
16. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. August 2026
Zuerst gepostet (Tatsächlich)
25. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
25. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2023/361
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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