NCT04062513

Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response

Effectiveness of Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: St. Justine's Hospital · Academic / Other
• Sex: All
• Age: 29 Weeks – 36 Weeks
• Healthy volunteers: Accepted

Summary

Repeated and untreated pain can lead to long-term consequences in preterm infants, such as pain hypersensitivity and impaired motor and intellectual development. Studies on the pharmacological and non-pharmacological interventions for pain management in preterm infants are limited. Thus, we investigated an intervention based on olfactive stimulation with mothers' milk. The aims of this study are: a) Evaluate the effectiveness of an olfactive stimulation intervention with mothers' milk odor on preterm procedural pain; b) Evaluate the effectiveness of adding a period of familiarization previous to the olfactive stimulation intervention with mothers' milk odor on preterm procedural pain. Preterm infants will be recruited and randomly assigned to three groups 1) mothers' milk odor during the nine hours before and during heel-prick, 2) mothers' milk odor during heel-prick, 3) standard care. Pain will be measured using a scale of pain adapted for preterm infants. This procedure with mothers'milk odor is inexpensive and easily performed.This study will significantly contribute to the advancement of knowledge on preterm infants pain management.

Conditions

• Pain, Acute
• Preterm Infant
• Breast Milk

Interventions

Type	Name	Description
OTHER	Olfactive stimulation intervention with familiarization	The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick. For the familiarization stage, infants were familiarized with the odor of their mothers' milk for 9 hours before heel prick.
OTHER	Olfactive stimulation intervention	The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.
OTHER	Standard care	Preterm infants will receive sucrose during heel prick.

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-08-20
• Last updated: 2019-08-20