Neonatal Pain Management and Pain Monitoring Using New Methods: A Randomized Controlled Trial With Crossover Design
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
研究概览
简要总结
The aim of this randomized controlled study with crossover design is to examine the effectiveness of mother-driven interventions, skin-to-skin contact (SSC) and recorded mother's heartbeats as sound and vibration (MHB), compared to oral glucose in relieving neonatal acute pain related to heel lance as a painful procedure.
The effectiveness of interventions will be assessed using validated pain scales (PIPP-R and NIAPAS), changes in sensory cortex activation (near-infrared spectroscopy, NIRS) and changes in physiological indicators (oxygen saturation, heart rate, respiratory rate). The secondary objectives will include evaluating the effectiveness of interventions in relation to infant recovery and evaluating the use of NIRS monitoring in relation to neonatal pain assessment scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Two research assistants (NICU nurses) who are blinded to the intervention condition (30% oral glucose and combination of 30% oral glucose and the mother's heartbeat intervention) will be perform calculation of infant PIPP-R and NIAPAS scores independently. Calculating NIAPAS scores will requires observation of the neonate's body, so during the skin-to-skin contact the intervention condition cannot be blinded. NIRS signals will be analyzed by researchers who are unaware of the nature of intervention and whether they are analyzing a noxious or non-noxious stimulation. To minimize observer bias, research assistants and researchers analyzing the NIRS signal will not be permitted to attend data collection sessions and will not share datasets or communicate with each other regarding the study.
入排标准
- 年龄范围
- 32 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational Age (GA) at birth 32+0 - 42+0
- •Admitted to NICU
- •Parents are able to read, write and speak Finnish
排除标准
- •With a postnatal age of 14 days or more
- •Apgar points were 6 or less at 5 minutes of age
- •Has been found grade III or IV cerebral haemorrhage
- •Major congenital anomalies
- •Has intubated or receiving a nCPAP
- •Has received analgesics or sedatives for less than 24 hours prior to the study
研究组 & 干预措施
Skin-to-skin contact
Neonates will be placed ventral skin-to-skin position with their mother at least thirty minutes prior the heel lance to give time to calm down following transfer. Skin-to-skin positioning will be taken account comfortable position as possible for mother and the baby, easy to access heel for blood sample and interference minimizing during video recording and continuous NIRS, ECG and oxygen saturation measurement. Skin-to-skin contact will be continued for approximately fifteen minutes after completion of blood sampling. In addition, the neonates will be given a 30% oral glucose solution two minutes prior the heel lance.
干预措施: Skin-to-skin contact (Behavioral)
Mother's heartbeats as sound and vibration
Neonates will be placed in an incubator or a cot, depending on their gestational age, and will be supported on side position by nest-shaped rolls according to department's normal practice. The platform on which the mother's heartbeat will be played will be placed under mattress of the incubator or crib. The playing of the mother's recorded heartbeats will be started thirty minutes prior the heel lance and will be continued during and fifteen minutes after the blood sampling. In addition, the neonates will be given a 30% oral glucose solution two minutes prior the heel lance.
干预措施: Mother's heartbeats as sound and vibration (Behavioral)
30% oral glucose
Neonates will be placed on in an incubator or a cot, depending on their gestational age, and will be supported on side position by nest-shaped rolls according to department's normal practice. The neonates will be given a 30% oral glucose solution two minutes prior the heel lance
干预措施: 30% oral glucose (Drug)
结局指标
主要结局
Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
时间窗: Measured immediately after painful procedure
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
时间窗: Measured immediately after painful procedure
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
Change of the activation in the somatosensory cortical areas following the noxious stimulation
时间窗: Measured immediately after painful procedure
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.
Change in heart rate (HR)
时间窗: Measured immediately after procedure
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.
Change in the activation in the somatosensory cortical areas following the noxious stimulation (baseline)
时间窗: Baseline 1, measured pre-intervention
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.
Change in the activation in the somatosensory cortical areas following the noxious stimulation
时间窗: Baseline 2, measured pre-procedure
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.
Change in oxygen saturation
时间窗: Measured immediately after painful procedure
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.
Change in respiratory rate
时间窗: Measured immediately after procedure
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.
次要结局
- Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)(10 minutes after painful procedure)
- Recovery as measured by changes in somatosensory cortex activation(10 minutes after painful procedure)
- Recovery as measured by changes in respiratory rate(10 minutes after painful procedure)
- Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)(10 minutes after painful procedure)
- Recovery as measured by changes in heart rate (HR)(10 minutes after painful procedure)
- Recovery as measured by changes in oxygen saturation(10 minutes after painful procedure)
研究者
Anna-Kaija Palomaa
PhD researcher
University of Oulu