Effectiveness of Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Acute
- Sponsor
- St. Justine's Hospital
- Enrollment
- 96
- Primary Endpoint
- Pain : Premature Infant Pain Profile-Revised
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
De Clifford-Faugère Gwenaelle
Principal investigator
St. Justine's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pain : Premature Infant Pain Profile-Revised
Time Frame: Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection
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.
Secondary Outcomes
- Recovery(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(Immediately post-procedure)