Neonatal Pain Management and Pain Monitoring Using New Methods

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oulu

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