The Effect of the Safe Swaddling Method and the Scent of Breast Milk on Physiological Parameters, Stress, and Comfort Levels in Premature Newborns Receiving Mechanical Ventilator Support: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Premature Baby Comfort Scale
研究概览
简要总结
It will be done to shorten the hospital stay of the newborn and increase the quality of care by proving the positive effect of the safe wrapping method and the smell of breast milk on the physiological parameters and stress level of the newborn in premature newborns receiving mechanical ventilator support.
- Safe wrapping method positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
- Safe wrapping method reduces stress in premature newborns receiving mechanical ventilation support.
- Safe wrapping method increases comfort in premature newborns receiving mechanical ventilation support.
- The smell of breast milk positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
- The smell of breast milk reduces stress in premature newborns receiving mechanical ventilation support.
- The smell of breast milk increases comfort in premature newborns receiving mechanical ventilation support.
This study aims to answer the hypotheses
详细描述
The universe of the study will consist of premature newborns receiving ventilator support in the neonatal intensive care clinic of Selçuk University Medical Faculty Hospital. Three groups will be included in the study: the wrapping group (24), the breastfeeding group (24), and a control group (24). The study data will be collected using the Introductory Information Form, Preterm Infant Physiological Measurement Form, Premature Infant Comfort Scale, and the Neonatal Stress Scale. Before randomization, general information about the study will be given to the parents of newborns who meet the inclusion criteria, the mothers' consent will be obtained, and pre-test data will be collected. Premature newborns receiving ventilator support, whose pre-test data have been collected, will be assigned to the intervention and control groups using the simple randomization method. The intervention will be applied one hour after the 18:00 care, 10 minutes before the procedure, considering the calmest and most stable hours of the research unit, and will be evaluated at the fifth and twentieth minutes after the procedure.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 34 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns with gestational weeks between 340/7-366/7,
- •In the first 28 days of life,
- •High-flow nasal cannula applied,
- •Birth weight 1500 gr and above,
- •Breastfeeding mothers,
- •No health problems that would prevent positioning,
排除标准
- •Those who have had a painful procedure within the last hour,
- •Those who have taken analgesic/sedative drugs within the last 6 hours,
- •Those who have undergone any surgical intervention,
- •Those with other diagnoses (hyperbilirubinemia, hypoglycemia, etc.),
- •Those with cerebral hypoxia/ischemia,
- •Those with intraventricular hemorrhage,
- •Newborns with congenital anomalies
结局指标
主要结局
Premature Baby Comfort Scale
时间窗: 9 Months
The scale was first developed by Ambuel et al. (1992) to assess the pain and stress levels of children aged 0-18 years hospitalized in a pediatric intensive care unit to determine the comfort levels of premature infants. It was later adapted by Caljouw et al. (2007) for premature infants aged 28-37 weeks. The scale is a 5-point Likert-type scale with seven subscales and 35 items. The subscales are defined as alertness, calmness/agitation, respiratory status or crying, physical movement, muscle tone, facial movements, and mean heart rate. The scale is a multidimensional measure that holistically assesses behavioral and physiological indicators of comfort in premature infants. As the total score on the scale increases, the infant's comfort level decreases; a score of 7 indicates the highest level of comfort, and a score of 35 indicates the lowest.
次要结局
- Newborn Stress Scale(9 Months)
研究者
Hediye Karakoç
Associate Professor
KTO Karatay University