Neonatal Pain Management and Pain Monitoring Using New Methods

Sponsor

University of Oulu (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04967118

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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), sensory cortex activation (near-infrared spectroscopy, NIRS), muscle tension (EMG) 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, evaluating the use of EMG and NIRS monitoring in neonatal pain assessment compared to pain scales, the assessment of neonatal glymphatic system by NIRS and the mother's view of interventions and experience of participation.

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute Procedural Pain Infant	Behavioral: Skin-to-skin contact Behavioral: Mother's heartbeats as sound and vibration Drug: 30% oral glucose	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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 (Outcomes Assessor)

Masking Description:

Three 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 and EMG 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 and EMG signal will not be permitted to attend data collection sessions and will not share datasets or communicate with each other regarding the study.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 30, 2021

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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, EMG and oxygen saturation measurement. Skin-to-skin contact will be continued for approximately thirty 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 thirty 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.
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

Arm

Intervention/Treatment

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, EMG and oxygen saturation measurement. Skin-to-skin contact will be continued for approximately thirty 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 thirty 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.

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

Outcome Measures

Primary Outcome Measures

Premature Infant Pain profile-Revised (PIPP-R) [Measured 30 seconds post-painful procedure]
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Premature Infant Pain profile-Revised (PIPP-R) [Measured 60 seconds post-painful procedure]
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Premature Infant Pain profile-Revised (PIPP-R) [Measured 90 seconds post-painful procedure]
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Premature Infant Pain profile-Revised (PIPP-R) [Measured 120 seconds post-painful procedure]
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Neonatal Infant Acute Pain Assessment Scale (NIAPAS) [Measured 30 seconds post-painful procedure]
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
Neonatal Infant Acute Pain Assessment Scale (NIAPAS) [Measured 60 seconds post-painful procedure]
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
Neonatal Infant Acute Pain Assessment Scale (NIAPAS) [Measured 90 seconds post-painful procedure]
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
Neonatal Infant Acute Pain Assessment Scale (NIAPAS) [Measured 120 seconds post-painful procedure]
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
The activation in the somatosensory cortical areas following the noxious stimulation [Measured 30 seconds post-painful procedure]
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 6-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 bilaterally over both somatosensory areas and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 and 4 cm from the emitted probes so that they are placed slightly behind and 1-2 cm above and below the C3 and C4 points depending on the size of the infant's head. The occipital region receive probes will be attached 2 and 4 cm from the emitted probe.
The activation in the somatosensory cortical areas following the noxious stimulation [Measured 60 seconds post-painful procedure]
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 6-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 bilaterally over both somatosensory areas and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 and 4 cm from the emitted probes so that they are placed slightly behind and 1-2 cm above and below the C3 and C4 points depending on the size of the infant's head. The occipital region receive probes will be attached 2 and 4 cm from the emitted probe.
The activation in the somatosensory cortical areas following the noxious stimulation [Measured 90 seconds post-painful procedure]
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 6-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 bilaterally over both somatosensory areas and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 and 4 cm from the emitted probes so that they are placed slightly behind and 1-2 cm above and below the C3 and C4 points depending on the size of the infant's head. The occipital region receive probes will be attached 2 and 4 cm from the emitted probe.
The activation in the somatosensory cortical areas following the noxious stimulation [Measured 120 seconds post-painful procedure]
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 6-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 bilaterally over both somatosensory areas and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 and 4 cm from the emitted probes so that they are placed slightly behind and 1-2 cm above and below the C3 and C4 points depending on the size of the infant's head. The occipital region receive probes will be attached 2 and 4 cm from the emitted probe.
Muscle activation related painful stimulus [Measured 30 seconds post-painful procedure]
The study will be evaluated the effect of painful stimulation on the activation of the Corrugator Supercilii muscle by electromyographic measurement (EMG). Several tools developed for neonatal pain assessment are based in part (e.g. NIAPAS, PIPP-R) or completely (e.g. Neonatal Facial Codin System) on the observation of facial expressions. In pain assessment tools, one indicator is the brow bulge, which has also been found in fetal studies to be related to stress or fetal distress. In this study, a Faros360 device will be used to measure muscle tension. Electrodes will be attached immediately above the eyebrows, laterally to the iris.
Muscle activation related painful stimulus [Measured 60 seconds post-painful procedure]
The study will be evaluated the effect of painful stimulation on the activation of the Corrugator Supercilii muscle by electromyographic measurement (EMG). Several tools developed for neonatal pain assessment are based in part (e.g. NIAPAS, PIPP-R) or completely (e.g. Neonatal Facial Codin System) on the observation of facial expressions. In pain assessment tools, one indicator is the brow bulge, which has also been found in fetal studies to be related to stress or fetal distress. In this study, a Faros360 device will be used to measure muscle tension. Electrodes will be attached immediately above the eyebrows, laterally to the iris.
Muscle activation related painful stimulus [Measured 90 seconds post-painful procedure]
The study will be evaluated the effect of painful stimulation on the activation of the Corrugator Supercilii muscle by electromyographic measurement (EMG). Several tools developed for neonatal pain assessment are based in part (e.g. NIAPAS, PIPP-R) or completely (e.g. Neonatal Facial Codin System) on the observation of facial expressions. In pain assessment tools, one indicator is the brow bulge, which has also been found in fetal studies to be related to stress or fetal distress. In this study, a Faros360 device will be used to measure muscle tension. Electrodes will be attached immediately above the eyebrows, laterally to the iris.
Muscle activation related painful stimulus [Measured 120 seconds post-painful procedure]
The study will be evaluated the effect of painful stimulation on the activation of the Corrugator Supercilii muscle by electromyographic measurement (EMG). Several tools developed for neonatal pain assessment are based in part (e.g. NIAPAS, PIPP-R) or completely (e.g. Neonatal Facial Codin System) on the observation of facial expressions. In pain assessment tools, one indicator is the brow bulge, which has also been found in fetal studies to be related to stress or fetal distress. In this study, a Faros360 device will be used to measure muscle tension. Electrodes will be attached immediately above the eyebrows, laterally to the iris.

Secondary Outcome Measures

Recovery [Time will vary across infant, but it is not expected to last more than 10 minutes.]
Time to recovery from painful stimulus will be considered the amount of time in seconds that pass until the neonates' pain scores (PIPP-R, NIAPAS), heart rate, oxygen saturation, respiratory rate, cortical hemodynamics (NIRS) and muscle activation (EMG) returns to baseline values.
Mother's view of interventions [Immediately after the baby has gone through all the interventions]
Mothers will be interviewed with a thematic interview immediately after their children have completed all three research interventions. The interview will focus on the mother's perceptions of the usability of each intervention, the effectiveness of the interventions in alleviating the child's pain, and the mother's experience of participating in the pain alleviation with different methods.

Eligibility Criteria

Criteria

Ages Eligible for Study:

32 Weeks to 42 Weeks

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Oulu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna-Kaija Palomaa, PhD researcher, University of Oulu

ClinicalTrials.gov Identifier:

NCT04967118

Other Study ID Numbers:

296/2018

First Posted:

Jul 19, 2021

Last Update Posted:

Jul 19, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Pain

Pain, Procedural

Study Results

No Results Posted as of Jul 19, 2021