Effects of Swaddle Bathing on Physiological Regulation and Stress-Reducing Behaviors in Preterm Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Behavioral Stress Scores
研究概览
简要总结
Background and Purpose: Bathing is a routine but essential part of care for preterm infants in the Neonatal Intensive Care Unit (NICU). However, traditional tub bathing can be a significant source of stress for these vulnerable infants, potentially leading to fluctuations in body temperature, heart rate, and oxygen levels. Swaddle bathing-a technique where the infant is wrapped in a light cloth during the bath-is thought to provide a sense of security and better physiological stability.
The goal of this pilot randomized controlled trial is to compare the effects of swaddle bathing versus conventional tub bathing in preterm infants. The researchers want to determine if swaddle bathing is as safe as traditional methods while being more comfortable for the baby.
Main Questions to Answer:
- Is swaddle bathing non-inferior to (as safe as) conventional tub bathing regarding the infant's physiological stability (e.g., body temperature and heart rate)?
- Does swaddle bathing significantly reduce stress-related behaviors and crying in preterm infants compared to conventional bathing?
Study Design and Procedure:
Participants will be randomly assigned to one of two groups:
- Experimental Group: Infants will receive swaddle bathing, where they remain snugly wrapped in a towel or wrap while being gently immersed in water.
- Control Group: Infants will receive conventional tub bathing according to standard hospital protocols.
During and after the bath, the research team will monitor the infants' vital signs and video-record their behavioral responses (such as facial expressions and limb movements) to evaluate their level of comfort and stress. The results of this study will provide preliminary evidence to help clinical nurses decide the best bathing practices for promoting the neurodevelopmental care of preterm infants.
详细描述
Study Overview:
This pilot randomized controlled trial (RCT) aims to evaluate the physiological safety and behavioral comfort of swaddle bathing compared to conventional tub bathing in preterm infants. The study is designed to provide preliminary evidence on whether swaddle bathing serves as a neurodevelopmental care intervention that maintains thermal and cardiovascular stability while reducing stress-related behaviors during a routine nursing procedure in the Neonatal Intensive Care Unit (NICU).
Research Methodology:
Participants will be recruited from a NICU and randomly assigned to either the experimental group (swaddle bathing) or the control group (conventional tub bathing) using a block randomization method. To ensure safety, all bathing procedures will be conducted by trained neonatal nurses and monitored for any signs of physiological distress.
Intervention Protocols:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 32 and 36 weeks and 6 days
- •Birth weight greater than 1,500 grams
- •Clinically stable as determined by the attending neonatologist
- •Receiving the first bath after birth
排除标准
- •Major congenital anomalies, such as cyanotic heart disease, gastroschisis, or open spinal defects
- •Severe intraventricular hemorrhage (Grade III or IV)
- •Skin impairments or open wounds that contraindicate water immersion, including surgical sites
- •Continuous use of sedatives or muscle relaxants that may interfere with behavioral assessments
研究组 & 干预措施
Swaddle Bathing
Preterm infants in this group will receive swaddle bathing, a developmental care intervention designed to maintain physiological stability and reduce stress during the bathing process.
干预措施: Swaddle Bathing (Other)
Conventional Tub Bathing
Preterm infants in this group will receive the standard conventional tub bathing according to the hospital's current clinical protocol.
干预措施: Conventional Tub Bathing (Other)
结局指标
主要结局
Behavioral Stress Scores
时间窗: During the 5-minute bathing procedure
Behavioral stress is assessed using a checklist based on the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) principles (Als \& McAnulty, 2011), adapted from the Taiwan Society of Neonatology Developmental Care Manual (Taiwan Society of Neonatology, 2021). Assessment: The frequency of 10 stress-related behaviors (including motor and neurophysiological cues) is recorded during the 5-minute bathing procedure. Scoring: The Behavioral Stress Score is calculated as the sum of all observed behavioral frequencies. The total score ranges from 0 with no theoretical maximum. A higher cumulative frequency (score) indicates greater behavioral stress in the preterm infant.
Body Temperature
时间窗: baseline (pre-bath), immediately post-bath, and 10 minutes post-bath.
次要结局
- Heart Rate(baseline (pre-bath), immediately post-bath, and 10 minutes post-bath.)
- Percentage of Crying Time(During the 5-minute bathing procedure)
- oxygen saturation(baseline (pre-bath), immediately post-bath, 10 minutes post-bath)
研究者
Ying-Mei Liu
Associate Professor
Chang Gung University of Science and Technology