The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns on Mechanical Ventilation: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Neonatal Comfort Behavior Scale
研究概览
简要总结
This study was conducted in a randomized controlled experimental type to determine the effect of maternal voice during care on pain and comfort level in term newborns receiving mechanical ventilation. The sample of the study was consisted of 60 term newborns receiving mechanical ventilation who were hospitalized in the 7-bed Neonatal Intensive Care Unit of a private hospital in Istanbul in accordance with the selection criteria. Introductory Information Form, Vital Signs Follow-up Form, Neonatal Comfort Behavior Scale and Neonatal Pain Scale (NPASS) forms prepared by the researchers were used as data collection tools.
详细描述
Intervention group: During the care, from the beginning to the end, mother's voice was played to the newborns. It took about 20 minutes. The mini Bluetooth speaker and the decibel meter were disinfected with the rapid surface disinfectant used in the clinic. The speaker was placed 30 cm away from the infant's ear and the sound level in the incubator was adjusted to be 50-60 dB by using a decibel meter Mother's voice was played from the beginning of the provision of care and continued for 15 minutes after the end of the provision of care. During the provision of care, COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form.
Control group: Standard nursing care lasting 20 minutes was performed in the routine sound environment of the neonatal intensive care unit. COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form.
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
- 3 Weeks 至 41 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Connected to a mechanical ventilator (intubation or nasal CPAP),
- •Term newborns (born at 37-42 weeks),
- •No neurological disorders,
- •No congenital or acquired hearing malformations,
- •The family consents for their infant to participate in the study,
排除标准
- •Diagnosis of asphyxia,
- •Use of sedatives or analgesics,
- •Congenital anomaly,
- •Underwent an extra invasive procedure or surgical intervention,
- •Parents with congenital hearing problems.
结局指标
主要结局
Neonatal Comfort Behavior Scale
时间窗: 20 minutes
The scale is for 0-100-day-old infants and term or preterm newborns experiencing acute or chronic pain and treated with or without mechanical ventilation.
次要结局
- Neonatal Comfort Behavior Scale (COMFORTneo):(20 minutes)
研究者
aysel kokcudogan
Assistant professor
Istanbul Medipol University Hospital