Neonatal Pain Management and Pain Monitoring Using New Methods

Study Overview
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Brief Summary
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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.

Official Title
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Neonatal Pain Management and Pain Monitoring Using New Methods: A Randomized Controlled Trial With Crossover Design

Conditions
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Infant, Pain, Acute, Procedural Pain

Intervention / Treatment
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* Behavioral: Skin-to-skin contact
* Behavioral: Mother's heartbeats as sound and vibration
* Drug: 30% oral glucose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational Age (GA) at birth 32+0 - 42+0 Admitted to NICU Parents are able to read, write and speak Finnish Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 32 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A crossover design with each child as his or her own control will be used to minimize interchild variability. Order of interventions will be randomly assigned by computer-generated program.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin-to-skin contact<br>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. | Behavioral: Skin-to-skin contact<br>* Diaper clad baby will be placed ventral position on bare chest of mother 30 minute prior to the heel lance<br>* Other names: Kangaroo Mother Care;|
| Experimental: Mother's heartbeats as sound and vibration<br>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. | Behavioral: Mother's heartbeats as sound and vibration<br>* The mother's heartbeat will be recorded and the heartbeat sounds will be saved to the platform. The platform will be placed under the infant's mattress and the heartbeat will be started 30 minute prior to the heel lance.<br>|
| Active Comparator: 30% oral glucose<br>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 | Drug: 30% oral glucose<br>* The infant will be given 30% oral glucose solution 2 minutes before the injection<br>* Other names: Sweet taste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale | 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. | Baseline 1, measured pre-intervention | 
| Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale | 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. | Baseline 2, measured pre-procedure | 
| Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale | 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. | Measured during painful procedure | 
| Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale | 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. | Measured immediately after painful procedure | 
| Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS) | 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. | Baseline 1, measured pre-intervention | 
| Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS) | 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. | Baseline 2, measured pre-procedure | 
| Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS) | 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. | Measured during painful procedure | 
| Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS) | 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. | Measured immediately after painful procedure | 
| Change in the activation in the somatosensory cortical areas following the noxious stimulation (baseline) | 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. | Baseline 1, measured pre-intervention | 
| Change in the activation in the somatosensory cortical areas following the noxious stimulation | 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. | Baseline 2, measured pre-procedure | 
| Change of the activation in the somatosensory cortical areas following the noxious stimulation | 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. | Measured during painful procedure | 
| Change of the activation in the somatosensory cortical areas following the noxious stimulation | 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. | Measured immediately after painful procedure | 
| Change in heart rate (HR) | 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. | Baseline 1, measured pre-intervention | 
| Change in heart rate (HR) | 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. | Baseline 2, measured pre-procedure | 
| Change in heart rate (HR) | 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. | Measured during painful procedure | 
| Change in heart rate (HR) | 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. | Measured immediately after procedure | 
| Change in oxygen saturation | 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. | Baseline 1, measured pre-intervention | 
| Change in oxygen saturation | 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. | Baseline 2, measured pre-procedure | 
| Change in oxygen saturation | 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. | Measured during painful procedure | 
| Change in oxygen saturation | 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. | Measured immediately after painful procedure | 
| Change in respiratory rate | 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. | Baseline 1, measured pre-intervention | 
| Change in respiratory rate | 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. | Baseline 2, measured pre-procedure | 
| Change in respiratory rate | 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. | Measured during procedure | 
| Change in respiratory rate | 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. | Measured immediately after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R) | Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' PIPP-R scores returns to baseline values. | 3 minutes after painful procedure | 
| Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R) | Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' PIPP-R scores returns to baseline values. | 5 minutes after painful procedure | 
| Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R) | Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' PIPP-R scores returns to baseline values. | 10 minutes after painful procedure | 
| Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS) | Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' NIAPAS scores returns to baseline values. | 3 minutes after painful procedure | 
| Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS) | Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' NIAPAS scores returns to baseline values. | 5 minutes after painful procedure | 
| Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS) | Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' NIAPAS scores returns to baseline values. | 10 minutes after painful procedure | 
| Recovery as measured by changes in somatosensory cortex activation | Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the activation in the somatosensory cortical area measured by NIRS returns to baseline values. | 3 minutes after painful procedure | 
| Recovery as measured by changes in somatosensory cortex activation | Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the activation in the somatosensory cortical area measured by NIRS returns to baseline values. | 5 minutes after painful procedure | 
| Recovery as measured by changes in somatosensory cortex activation | Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the activation in the somatosensory cortical area measured by NIRS returns to baseline values | 10 minutes after painful procedure | 
| Recovery as measured by changes in heart rate (HR) | The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor. | 3 minutes after painful procedure | 
| Recovery as measured by changes in heart rate (HR) | The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor. | 5 minutes after painful procedure | 
| Recovery as measured by changes in heart rate (HR) | The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor. | 10 minutes after painful procedure | 
| Recovery as measured by changes in oxygen saturation | The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in oxygen saturation using a patient monitor. | 3 minutes after painful procedure | 
| Recovery as measured by changes in oxygen saturation | The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in oxygen saturation using a patient monitor. | 5 minutes after painful procedure | 
| Recovery as measured by changes in oxygen saturation | The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in oxygen saturation using a patient monitor. | 10 minutes after painful procedure | 
| Recovery as measured by changes in respiratory rate | The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor. | 3 minutes after painful procedure | 
| Recovery as measured by changes in respiratory rate | The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor. | 5 minutes after painful procedure | 
| Recovery as measured by changes in respiratory rate | The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor. | 10 minutes after painful procedure |