THE EFFECT OF VOCAL SOOTHING DURING NURSING CARE ON INFANT STRESS AND PHYSIOLOGICAL PARAMETERS IN THE NEONATAL INTENSIVE CARE UNIT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- Neonatal Stress Assessment Scale
研究概览
简要总结
The aim of this study is to determine the effect of verbal soothing applied by the researcher during routine nursing care in the neonatal intensive care unit on neonatal stress and physiological parameters.
Newborns will be divided into two groups, an intervention group and a control group, using simple randomization. Verbal soothing will be applied to the intervention group during routine nursing care (eye care, oral care, diaper changing, probe placement, weight measurement, body care), while no intervention will be performed on the infants in the control group; only routine care procedures will be applied.
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
- None
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns with a gestational age between 32 0/7 and 36 6/7 weeks
- •Newborns with an APGAR score above 6 at 5 minutes
- •Newborns weighing over 1000 grams
- •Newborns not on mechanical ventilation
- •Newborns who have been fed at least one hour prior to care
- •Newborns cared for in an incubator
- •Newborns who have passed the hearing test
排除标准
- •Presence of a condition that prevents the assessment of stress and physiological parameters (birth trauma, intracranial hemorrhage, congenital anomaly, etc.),
- •Undergoing an invasive procedure that causes different stress at least one hour before the care (intravenous access, aspiration procedure, etc.),
- •Administration of sedatives, opioids, and anticonvulsant drugs before the care.
研究组 & 干预措施
Vocal Shooting Group
Newborns in this group receive researcher-delivered vocal shooting during nursing care procedures in the NICU.
干预措施: vocal soothing (Behavioral)
Control Group
Newborns in this group will not undergo any intervention by the researcher; routine care procedures will be applied.
结局指标
主要结局
Neonatal Stress Assessment Scale
时间窗: The Neonatal Stress Scale will be completed by a pre-assigned nurse approximately 1 minute before care begins, 5 minutes after care starts, and 1 minute after care ends. The same nurse will then complete the stress scale and the newborn follow-up form.
The Neonatal Stress Assessment Scale (NISS) was developed by Ceylan and Bolışık (2017) to assess stress levels in premature infants. The scale consists of 24 items on a 3-point Likert scale, comprising 8 subgroups including facial expression, body color, breathing, activity level, soothing ability, muscle tone, extremities, and posture. Each subgroup is scored from 0 to 2 points. The minimum score is 0, and the maximum is 16. A high score indicates increased stress. The scale is evaluated through observation. It is sufficient for the infant to exhibit only one behavior from each cell in their free-standing space. A high value is valid if the infant exhibits behaviors from two different cell types (for example, if the infant shows signs corresponding to both 1 and 2 points). A stable and regular state indicates a high value of 0.
次要结局
- PHYSIOLOGICAL PARAMETERS(Routine nursing care will last approximately 10 minutes. The information sheet will be filled out by a nurse selected from the clinic 1 minute before, in the middle of, and 5 minutes after the routine nursing care for newborns.)
研究者
Egenaz Gülten Yaman
Master's Student
Aydin Adnan Menderes University