NCT04967118

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 32 Weeks – 42 Weeks
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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.
DRUG	30% oral glucose	The infant will be given 30% oral glucose solution 2 minutes before the injection

Timeline

• Start date: 2023-05-02
• Primary completion: 2024-05-31
• Completion: 2024-12-31
• First posted: 2021-07-19
• Last updated: 2023-11-30

Locations

1 site across 1 country: Finland