- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07725094
Maternal Sensory Interventions in Newborns (MSI)
2026년 7월 24일 업데이트: Edanur Tar Bolacali, Kirsehir Ahi Evran Universitesi
The Effect of Maternal Sensory Stimulation (Kangaroo Care, Lullabies, Tactile-Auditory Soothing) on Newborns' Sleep-Wake State and Physiological Parameters: A Randomized Controlled Trial
This study was designed to determine the effects of maternal sensory interventions (kangaroo care, lullabies, and maternal tactile-auditory soothing) on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the neonatal intensive care unit.
연구 개요
상태
아직 모집하지 않음
상세 설명
Sleep organization and physiological stability are essential indicators of neurological development and overall health in newborns.
However, newborns hospitalized in neonatal intensive care units (NICUs) are frequently exposed to environmental stressors, including excessive noise, continuous lighting, routine caregiving activities, and medical procedures, which may adversely affect sleep quality and physiological stability.
Maternal sensory interventions are non-pharmacological developmental care approaches that may promote relaxation, improve sleep organization, and support physiological regulation through tactile and auditory stimulation.
This study is designed as a single-center, four-arm, parallel-group randomized controlled trial to evaluate the effects of maternal sensory interventions on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the NICU.
Eligible clinically stable newborns will be randomly assigned in a 1:1:1:1 ratio to one of four groups: kangaroo care, maternal lullaby, maternal tactile-auditory soothing, or routine care (control).
Following routine midday care and feeding, newborns in the kangaroo care group will receive uninterrupted skin-to-skin contact with their mothers for 60 minutes.
In the maternal lullaby group, mothers will sing a lullaby of their choice for 15 minutes.
In the maternal tactile-auditory soothing group, mothers will gently provide rhythmic tactile stimulation to the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds ("pış pış") for 15 minutes.
Infants in the control group will receive routine NICU care without additional intervention.
All newborns will be monitored for a total of 60 minutes following the intervention or routine care.
Sleep-wake states will be continuously assessed using the Bispectral Index (BIS) monitor.
Physiological parameters, including heart rate, respiratory rate, and oxygen saturation, will be recorded at predetermined time points using standard patient monitoring equipment.
Sleep onset latency, as well as the duration of wakefulness, REM sleep, light sleep, and deep sleep, will be calculated from BIS recordings.
The findings of this study are expected to provide evidence regarding the effectiveness of maternal sensory interventions in improving sleep organization and physiological stability in newborns and to contribute to the development of evidence-based developmental care practices in neonatal intensive care units.
연구 유형
중재적
등록 (추정된)
80
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Edanur Tar Bolacali, PhD
- 전화번호: +908504412483
- 이메일: edanurtar.1107@gmail.com
연구 연락처 백업
- 이름: Sibel Kucukoglu, PhD
- 전화번호: +903322231623
- 이메일: s_nadaroglu@hotmail.com
연구 장소
-
-
Kırşehir
-
Kırşehir, Kırşehir, 터키 (Türkiye), 40100
- Kirsehir Ahi Evran Universty
-
연락하다:
- Edanur Tar Bolacalı, PhD
- 전화번호: +908504412483
- 이메일: edanurtar.1107@gmail.com
-
-
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
예
설명
Inclusion Criteria:
- Gestational age between 35 and 42 completed weeks.
- Birth weight between 2,000 and 4,200 grams.
- Clinically stable newborn admitted to the neonatal intensive care unit.
- Spontaneous breathing without the need for mechanical ventilation.
- Not receiving sedative medications.
- Written informed consent obtained from a parent or legal guardian.
Exclusion Criteria:
- Five-minute Apgar score <4.
- Requirement for advanced resuscitation after birth.
- Presence of a major congenital anomaly.
- Requirement for invasive intervention involving the head region.
- Diagnosed central nervous system dysfunction or neurological disorder.
- Presence of severe postnatal medical complications that may affect study outcomes.
Exclusion Criteria (during the research):
- The newborn develops an unexpected need for resuscitation during the study, as this may adversely affect the central nervous system and consequently influence sleep-wake patterns and study outcomes.
- A parent or legal guardian withdraws consent for the newborn's participation in the study.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention Group 1: Kangaroo Care
Participants assigned to this group will receive kangaroo care provided by their mothers for 60 minutes following routine midday care and feeding.
Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.
|
Kangaroo care will be provided by the mother for 60 minutes following routine midday care and feeding.
The newborn, wearing only a diaper, will be placed in an upright skin-to-skin position on the mother's bare chest.
The infant's head will be positioned to maintain airway patency, and a light blanket will be used to maintain thermal stability.
Sleep-wake states, sleep onset latency, and physiological parameters will be monitored throughout the 60-minute observation period.
|
|
실험적: Intervention Group 2: Maternal Lullaby
Participants assigned to this group will receive maternal lullaby intervention for 15 minutes following routine midday care and feeding.
Mothers will sing a lullaby of their choice while the infant remains in the crib.
Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.
|
Following routine midday care and feeding, mothers will sing a lullaby of their choice to their newborn for 15 minutes while the infant remains in the crib.
The lullaby will be performed in a soft, soothing voice at a sound level not exceeding 45-50 dB.
Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.
|
|
실험적: Intervention Group 3: Maternal Tactile-Auditory Soothing
Participants assigned to this group will receive maternal tactile-auditory soothing for 15 minutes following routine midday care and feeding.
Mothers will provide gentle rhythmic tactile stimulation to the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds ("pış pış").
Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.
|
Following routine midday care and feeding, mothers will provide gentle rhythmic tactile stimulation by softly stroking the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds ("pış pış") for 15 minutes.
The sound level will not exceed 45-50 dB.
Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.
|
|
간섭 없음: Routine Care (Control)
Participants assigned to this group will receive routine neonatal intensive care without any additional sensory intervention.
Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes following routine care.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Sleep Onset Latency
기간: From the beginning of the intervention until sleep onset, assessed within 60 minutes
|
Sleep onset latency will be defined as the time, in minutes, from the beginning of the assigned intervention or routine care until the BIS value first decreases below 91, indicating transition from wakefulness to sleep.
|
From the beginning of the intervention until sleep onset, assessed within 60 minutes
|
|
Sleep-Wake States Assessed by Bispectral Index
기간: During the 60-minute observation period following routine midday care and feeding
|
Sleep-wake states will be assessed continuously using the Bispectral Index (BIS), a processed electroencephalographic monitoring system with scores ranging from 0 to 100, where higher scores indicate greater wakefulness and lower scores indicate deeper levels of sleep.
BIS values will be classified as wakefulness (91-100), REM sleep (80-90), light sleep (55-79), and deep sleep (0-54).
The duration and percentage of time spent in each sleep-wake state will be calculated during the 60-minute observation period.
|
During the 60-minute observation period following routine midday care and feeding
|
|
Mean Bispectral Index Score
기간: During the 60-minute observation period
|
The mean Bispectral Index (BIS) score will be calculated from values recorded at one-minute intervals throughout the 60-minute monitoring period.
BIS scores range from 0 to 100, with higher scores indicating greater wakefulness and lower scores indicating deeper sleep.
|
During the 60-minute observation period
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Heart Rate
기간: Baseline, 15, 30, and 60 minutes after the intervention or routine care
|
Heart rate (beats per minute) will be recorded using the standard patient monitor at baseline (0 minutes) and at 15, 30, and 60 minutes during the observation period.
|
Baseline, 15, 30, and 60 minutes after the intervention or routine care
|
|
Respiratory Rate
기간: Baseline, 15, 30, and 60 minutes after the intervention or routine care
|
Respiratory rate (breaths per minute) will be recorded using the standard patient monitor at baseline (0 minutes) and at 15, 30, and 60 minutes during the observation period.
|
Baseline, 15, 30, and 60 minutes after the intervention or routine care
|
|
Oxygen Saturation (SpO₂)
기간: Baseline, 15, 30, and 60 minutes after the intervention or routine care
|
Peripheral oxygen saturation (SpO₂, %) will be measured using the standard patient monitor at baseline (0 minutes) and at 15, 30, and 60 minutes during the observation period.
|
Baseline, 15, 30, and 60 minutes after the intervention or routine care
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Caba-Flores MD, Ramos-Ligonio A, Camacho-Morales A, Martinez-Valenzuela C, Viveros-Contreras R, Caba M. Breast Milk and the Importance of Chrononutrition. Front Nutr. 2022 May 12;9:867507. doi: 10.3389/fnut.2022.867507. eCollection 2022.
- Huang Q, Lai X, Liao J, Tan Y. Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2021 Oct 29;100(43):e27587. doi: 10.1097/MD.0000000000027587.
- Yasova Barbeau D, Krueger C, Huene M, Copenhaver N, Bennett J, Weaver M, Weiss MD. Heart rate variability and inflammatory markers in neonates with hypoxic-ischemic encephalopathy. Physiol Rep. 2019 Aug;7(15):e14110. doi: 10.14814/phy2.14110.
- intensive care unit. Medicine, 100(43), e27587. https://doi.org/10.1097/md.0000000000027587 Kahraman, A., Başbakkal, Z., & Yalaz, M. (2014). Turkish validity and reliability of the Newborn Comfort Behavior Scale. International Refereed Journal of Nursing Research, 1(2), 1-11.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 15일
기본 완료 (추정된)
2026년 10월 15일
연구 완료 (추정된)
2026년 12월 30일
연구 등록 날짜
최초 제출
2026년 7월 21일
QC 기준을 충족하는 최초 제출
2026년 7월 21일
처음 게시됨 (실제)
2026년 7월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 24일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- KAEU-NICU-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .