Neonatal Pain Management and Pain Monitoring Using New Methods

University of Oulu

Status: Enrolling

Conditions: Pain, Acute; Infant; Procedural Pain

Treatments: Behavioral: Mother's heartbeats as sound and vibration; Drug: 30% oral glucose; Behavioral: Skin-to-skin contact

Study type: Interventional

Funder types: Other

Identifiers

NCT04967118

296/2018

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 32 to 42 weeks old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 3 patient groups

Skin-to-skin contact

Experimental group

Description:

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.

Treatment:

Behavioral: Skin-to-skin contact

Mother's heartbeats as sound and vibration

Experimental group

Description:

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.

Treatment:

Behavioral: Mother's heartbeats as sound and vibration

30% oral glucose

Active Comparator group

Description:

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

Treatment:

Drug: 30% oral glucose