Maternal Voice Versus White Noise in Pediatric Surgery
2026년 8월 22일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
90
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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İ̇zmi̇t
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Kocaeli, İ̇zmi̇t, 터키 (Türkiye)
- Kocaeli University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain Assessed Using the Face, Legs, Activity, Cry, and Consolability Scale
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Recovery Assessed Using the Modified Aldrete Recovery Score
기간: 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
기간: 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
기간: 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
기간: 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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연구 기록 날짜
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기본 완료 (실제)
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연구 등록 날짜
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처음 게시됨 (실제)
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