Neonatal Pain Management and Pain Monitoring Using New Methods

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Acute; Infant; Procedural Pain
• Intervention / Treatment: Behavioral: Skin-to-skin contact; Behavioral: Mother's heartbeats as sound and vibration; Drug: 30% oral glucose

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna-Kaija Palomaa; Phone Number: +358400892159; Email: annakaija.palomaa@gmail.com

Study Locations

• Finland
  • Oulu, Finland, 90029
    • Recruiting
    • Oulu University Hospita
    • Contact: Anna-Kaija Palomaa; Phone Number: +358400892159; Email: annakaija.palomaa@gmail.com
    • Contact: Tarja Pölkki, profesor; Phone Number: +358405817069; Email: tarja.polkki@oulu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 9 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oulu

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Pain, Procedural
• Other Study ID Numbers: 296/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No