Effect of an Automatic Infant Swing on Sleep-Wake Cycles, Comfort Behaviors, and Physiological Parameters in Newborns: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Primary Outcome 1: COMFORTneo Total Score
研究概览
简要总结
This study was planned to determine the effects of automatic baby swing application on the sleep-wake cycle, comfort behaviors and physiological parameters of babies in the neonatal intensive care unit.
详细描述
Sleep patterns and behavioral comfort during the neonatal period are important indicators of neurological development and physiological stability. However, noise, light, and constant medical interventions and care practices in the NICU environment can negatively affect infants' sleep continuity and quality of rest. Therefore, non-pharmacological approaches that provide sensory support, such as rhythmic and gentle rocking, are thought to be effective in promoting infant relaxation and physiological balance. In this study, an automatic baby swing with adjustable speed and rhythm will be used as an intervention to support infant comfort and sleep organization. Clinically stable term and preterm newborns who meet the specified inclusion criteria will be included in the study. Participants will be randomly assigned to two groups: the intervention group (first automatic swing application, then measurement without the swing) and the control group (first measurement without the swing, then measurement in the automatic baby swing). The intervention will be implemented for 60 minutes after daytime care at 9:00 AM and 12:00 PM, and for 60 minutes after nighttime care at 9:00 PM and 12:00 AM. The infants' BIS values, comfort, and physiological parameters will be monitored throughout the entire process. The study will evaluate the infants' sleep-wake cycles, comfort behaviors (e.g., facial expressions, body movements, crying), and physiological parameters (e.g., heart rate, respiratory rate, oxygen saturation) as outcome variables. Data will be collected using standardized observation forms and monitoring devices. This study is expected to contribute to evidence-based nursing practice by demonstrating the effects of movement-based nonpharmacological interventions on newborn comfort, sleep quality, and physiological stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •gestational age between 35-42 weeks,
- •birth weight >2000-4200 grams,
- •stable health status,
- •spontaneous breathing,
- •no sedation,
- •parental volunteering to participate in the study.
排除标准
- •- A 5-minute APGAR score below 4 at birth,
- •Requirement of resuscitation,
- •Presence of a congenital anomaly,
- •Requirement of interventional intervention in the head region,
- •Presence of central nervous system dysfunction,
- •Presence of postpartum medical complications.
- •Exclusion Criteria (during the research):
- •Sudden need for resuscitation Sudden deterioration of the stabilization of health status
结局指标
主要结局
Primary Outcome 1: COMFORTneo Total Score
时间窗: At 0, 30, and 60 minutes.
The COMFORTneo scale assesses seven behavioral and physiological parameters (muscle tone, alertness, facial tension, calmness/agitation, body movements, respiratory response, and crying). These parameters will be combined to produce a single total score (range 6-30). Only the total score will be reported.
次要结局
- Secondary Outcome 1: Infant Body Temperature(At 0, 30, and 60 minutes.)
- Secondary Outcome 2: Infant Heart Rate(At 0, 30, and 60 minutes.)
- Secondary Outcome 3: Infant Respiratory Rate(At 0, 30, and 60 minutes.)
- Secondary Outcome 4: Infant Oxygen Saturation(At 0, 30, and 60 minutes.)
- Secondary Outcome 5: Infant Blood Pressure(At 0, 30, and 60 minutes.)
研究者
Edanur Tar Bolacali
Asst. Prof.
Kirsehir Ahi Evran Universitesi