Evaluation of the Effects of Therapeutic Positioning on Physiological Parameters, Comfort, and Pain Levels in Premature Neonates on Mechanical Ventilation: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain Level Assessed Using the Premature Infant Pain Profile-Revised
研究概览
简要总结
This randomized controlled trial evaluated the effects of three therapeutic positions on physiological parameters, pain, and comfort in mechanically ventilated preterm infants. A total of 60 preterm infants born between 35 and 37 weeks of gestation were randomly assigned to the supine, prone, or fetal position group, with 20 infants in each group. Physiological parameters, pain, and comfort were assessed at baseline, 30 minutes, 2 hours, and 3 hours after positioning. Pain was assessed using the Premature Infant Pain Profile-Revised, and comfort was assessed using the COMFORTneo scale.
详细描述
Preterm infants receiving mechanical ventilation are exposed to physiological instability, pain, environmental stressors, and reduced comfort during neonatal intensive care. Therapeutic positioning is a non-pharmacological nursing intervention that may support oxygenation, physiological stability, neurobehavioral organization, and comfort.
This three-arm, parallel-group randomized controlled trial was conducted among mechanically ventilated preterm infants born between 35 and 37 weeks of gestation. Infants meeting the eligibility criteria were randomly assigned in a 1:1:1 ratio to the supine position, prone position, or fetal position group. Randomization was performed using a computer-generated random number sequence by an independent researcher.
The assigned position was applied according to a standardized positioning protocol. Ventilator settings were not changed as part of the positioning intervention. Physiological parameters, including heart rate, respiratory rate, peripheral oxygen saturation, and body temperature, were recorded at baseline, 30 minutes, 2 hours, and 3 hours. Pain was assessed using the Premature Infant Pain Profile-Revised, and comfort was assessed using the COMFORTneo scale at the same time points.
The study was designed to determine whether prone and fetal positioning improve physiological stability, reduce pain, and increase comfort compared with routine supine positioning in mechanically ventilated preterm infants.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 支持治疗
- 盲法
- 单盲 (受试者)
入排标准
- 年龄范围
- 35 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Preterm infants born between 35 and 37 weeks of gestation
- Receiving invasive or non-invasive mechanical ventilatory support
- Clinically stable before positioning
- No additional comfort-enhancing intervention administered during the study assessment period
- Written informed consent provided by a parent or legal guardian
排除标准
- Gestational age below 35 weeks or above 37 weeks
- Receiving phototherapy during the study assessment period
- Presence of a congenital anomaly
- Receiving sedative medication
- Clinical instability preventing the application of the assigned position
研究组 & 干预措施
Supine Position
Infants assigned to the control group were placed in the supine position. The infant was positioned on the back, with the head maintained in the midline, according to the standardized positioning protocol. The position was maintained during the three-hour assessment period.
干预措施: Prone Position (Other)
Supine Position
Infants assigned to the control group were placed in the supine position. The infant was positioned on the back, with the head maintained in the midline, according to the standardized positioning protocol. The position was maintained during the three-hour assessment period.
干预措施: Fetal Position (Other)
Prone Position
Infants assigned to this group were placed in the prone position. The trunk and pelvis were supported, and the head was turned slightly to one side according to the standardized positioning protocol. The position was maintained during the three-hour assessment period.
干预措施: Supine Position (Other)
Prone Position
Infants assigned to this group were placed in the prone position. The trunk and pelvis were supported, and the head was turned slightly to one side according to the standardized positioning protocol. The position was maintained during the three-hour assessment period.
干预措施: Fetal Position (Other)
Fetal Position
Infants assigned to this group were placed in a flexion-based fetal position. The upper and lower extremities were maintained in flexion, and appropriate positioning supports were used to mimic the intrauterine posture. The position was maintained during the three-hour assessment period.
干预措施: Supine Position (Other)
结局指标
主要结局
Pain Level Assessed Using the Premature Infant Pain Profile-Revised
时间窗: Baseline, 30 minutes, 2 hours, and 3 hours after positioning
Pain Level Assessed Using the Premature Infant Pain Profile-Revised
次要结局
- Comfort Level Assessed Using the COMFORTneo Scale(Baseline, 30 minutes, 2 hours, and 3 hours after positioning)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07845435
- 其他研究编号
- 15
日期
- 首次提交
- (8天前)
- 首次发布
- (前天)
- 主要完成日期
- (去年)
- 研究完成日期
- (11个月前)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否