Neonatal Pain Management and Pain Monitoring Using New Methods

NCT04967118 | Unknown

• 1 other identifier: 296/2018
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Procedural Pain; Infant

Outcome Measures

Primary Outcomes (24)

• 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 Outcomes (18)

• Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)

  3 minutes after painful procedure

• Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)

  5 minutes after painful procedure

• Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)

  10 minutes after painful procedure

• Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)

  3 minutes after painful procedure

• Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)

  5 minutes after painful procedure

Study Arms (3)

Skin-to-skin contact

EXPERIMENTAL

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

Mother's heartbeats as sound and vibration

EXPERIMENTAL

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

30% oral glucose

ACTIVE COMPARATOR

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

Interventions

Skin-to-skin contact BEHAVIORAL

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

Skin-to-skin contact

Mother's heartbeats as sound and vibration BEHAVIORAL

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.

Mother's heartbeats as sound and vibration

30% oral glucose DRUG

The infant will be given 30% oral glucose solution 2 minutes before the injection

Also known as: Sweet taste

30% oral glucose

Eligibility Criteria

• Age: 32 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational Age (GA) at birth 32+0 - 42+0
• Admitted to NICU
• Parents are able to read, write and speak Finnish

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University Hospita

Oulu, 90029, Finland

RECRUITING

MeSH Terms

Conditions

Acute Pain; Pain, Procedural

Interventions

Kangaroo-Mother Care Method; Sound; Vibration; Glucose; Gurmarin protein, Gymnema sylvestre

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services; Radiation, Nonionizing; Radiation; Physical Phenomena; Mechanical Phenomena; Hexoses; Monosaccharides; Sugars; Carbohydrates

Central Study Contacts

Anna-Kaija Palomaa

CONTACT

+358400892159; annakaija.palomaa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD researcher

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: July 19, 2021
• Study Start: May 2, 2023
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

FI (1)