Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response

St. Justine's Hospital96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain, Acute Preterm Infant

Interventions

Olfactive stimulation intervention with familiarizationOTHER

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.

Olfactive stimulation interventionOTHER

The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.

Standard careOTHER

Preterm infants will receive sucrose during heel prick.

Eligibility

Sex: ALLMin age: 29 WeeksMax age: 36 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria for mothers * 18 years or older, * speak, understand and write French or English * express their milk Exclusion Criteria for mothers \- pathology or condition that contraindicates the use of their breast milk (HIV, drugs...) Inclusion Criteria for preterm * 29 to 36 weeks of gestation * APGAR \> 6 at 5 minutes * less than 21 days Exclusion Criteria for preterm * intubated, under Continuous Positive Airway Pressure or nasal oxygen, * surgery in the first day of life * congenital disease * intraventricular hemorrhage \> grade II * leukomalacia * sedation within 48 hours prior to heel prick * pharmacologic treatment for pain within 12 hours prior to heel prick * being under phototherapy treatment during the familiarization stage

Outcomes

Primary Outcomes

Pain : Premature Infant Pain Profile-Revised

Scores range from 0 to 21 where a higher score means more pain, a score less than 6 signifies an absence of pain, and a score greater than 12 indicates moderate to severe pain. The PIPP-R contains four parts: gestational age, state of sleep-awake, physiological parameters, and behavioural parameters.

Time frame: Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection

Secondary Outcomes

Recovery

Time frame: The time required for the preterm infant to return to baseline heart rate levels (should not exceed 5 minutes)

Maternal acceptability of the olfactive stimulation intervention : questionnaire

After the intervention, mothers will be asked to complete a questionnaire focusing on maternal acceptability of the olfactive stimulation intervention with mothers' milk to manage procedural pain (demographic questions and Likert scale).

Time frame: Immediately post-procedure