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Neonatal Pain Management and Pain Monitoring Using New Methods

Primary Purpose

Pain, Acute, Procedural Pain, Infant

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Skin-to-skin contact
Mother's heartbeats as sound and vibration
30% oral glucose
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

32 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Skin-to-skin contact

    Mother's heartbeats as sound and vibration

    30% oral glucose

    Arm Description

    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.

    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.

    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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    March 17, 2021
    Last Updated
    April 24, 2023
    Sponsor
    University of Oulu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04967118
    Brief Title
    Neonatal Pain Management and Pain Monitoring Using New Methods
    Official Title
    Neonatal Pain Management and Pain Monitoring Using New Methods: A Randomized Controlled Trial With Crossover Design
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Oulu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Acute, Procedural Pain, Infant

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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
    Outcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Skin-to-skin contact
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Mother's heartbeats as sound and vibration
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    30% oral glucose
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Skin-to-skin contact
    Other Intervention Name(s)
    Kangaroo Mother Care
    Intervention Description
    Diaper clad baby will be placed ventral position on bare chest of mother 30 minute prior to the heel lance
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mother's heartbeats as sound and vibration
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    30% oral glucose
    Other Intervention Name(s)
    Sweet taste
    Intervention Description
    The infant will be given 30% oral glucose solution 2 minutes before the injection
    Primary Outcome Measure Information:
    Title
    Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
    Description
    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
    Title
    Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
    Description
    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
    Title
    Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
    Description
    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
    Title
    Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
    Description
    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
    Title
    Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
    Description
    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
    Title
    Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
    Description
    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
    Title
    Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
    Description
    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
    Title
    Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
    Description
    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
    Title
    Change in the activation in the somatosensory cortical areas following the noxious stimulation (baseline)
    Description
    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
    Title
    Change in the activation in the somatosensory cortical areas following the noxious stimulation
    Description
    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
    Title
    Change of the activation in the somatosensory cortical areas following the noxious stimulation
    Description
    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
    Title
    Change of the activation in the somatosensory cortical areas following the noxious stimulation
    Description
    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
    Title
    Change in heart rate (HR)
    Description
    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
    Title
    Change in heart rate (HR)
    Description
    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
    Title
    Change in heart rate (HR)
    Description
    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
    Title
    Change in heart rate (HR)
    Description
    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
    Title
    Change in oxygen saturation
    Description
    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
    Title
    Change in oxygen saturation
    Description
    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
    Title
    Change in oxygen saturation
    Description
    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
    Title
    Change in oxygen saturation
    Description
    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
    Title
    Change in respiratory rate
    Description
    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
    Title
    Change in respiratory rate
    Description
    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
    Title
    Change in respiratory rate
    Description
    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
    Title
    Change in respiratory rate
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)
    Description
    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
    Title
    Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)
    Description
    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
    Title
    Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)
    Description
    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
    Title
    Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
    Description
    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
    Title
    Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
    Description
    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
    Title
    Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
    Description
    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
    Title
    Recovery as measured by changes in somatosensory cortex activation
    Description
    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
    Title
    Recovery as measured by changes in somatosensory cortex activation
    Description
    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
    Title
    Recovery as measured by changes in somatosensory cortex activation
    Description
    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
    Title
    Recovery as measured by changes in heart rate (HR)
    Description
    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
    Title
    Recovery as measured by changes in heart rate (HR)
    Description
    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
    Title
    Recovery as measured by changes in heart rate (HR)
    Description
    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
    Title
    Recovery as measured by changes in oxygen saturation
    Description
    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
    Title
    Recovery as measured by changes in oxygen saturation
    Description
    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
    Title
    Recovery as measured by changes in oxygen saturation
    Description
    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
    Title
    Recovery as measured by changes in respiratory rate
    Description
    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
    Title
    Recovery as measured by changes in respiratory rate
    Description
    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
    Title
    Recovery as measured by changes in respiratory rate
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    32 Weeks
    Maximum Age & Unit of Time
    42 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anna-Kaija Palomaa
    Phone
    +358400892159
    Email
    annakaija.palomaa@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Neonatal Pain Management and Pain Monitoring Using New Methods

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