An interventional study of Skin-to-skin contact and Mother's heartbeats as sound and vibration in Pain, Acute, Procedural Pain and Infant, sponsored by University of Oulu. Recruiting at 1 site in Finland. Open to participants aged 32 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by University of Oulu · Not applicable, Interventional, and Treatment
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.
237 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 36 is below the median of 83 across 223 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →University of Oulu is the lead sponsor of 138 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Diaper clad baby will be placed ventral position on bare chest of mother 30 minute prior to the heel lance
Also known as: Kangaroo Mother Care
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.
The infant will be given 30% oral glucose solution 2 minutes before the injection
Also known as: Sweet taste
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured immediately after 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 minutes after painful procedure
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