Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response

Not Applicable

• Conditions: Pain, Acute; Preterm Infant; Breast Milk
• Interventions: Other: Standard care; Other: Olfactive stimulation intervention; Other: Olfactive stimulation intervention with familiarization

• Registration Number: NCT04062513
• Lead Sponsor: St. Justine's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-16
• Last Update Submitted: 2019-08-16
• Study First Posted: 2019-08-20
• Last Update Posted: 2019-08-20
• Study Start: 2019-09
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	In the control arm, participants will receive the standard care for pain which is sucrose administration.
Olfactive stimulation intervention	Olfactive stimulation intervention	Participants will receive the olfactive stimulation intervention with mothers' milk odor during heel prick only. Sucrose will be also administered during heel prick.
Olfactive stimulation intervention with familiarization	Olfactive stimulation intervention with familiarization	Participants will receive the olfactive stimulation intervention with mothers' milk odor during a previous period of nine hours and during heel prick. Sucrose will be also administered during heel prick.

Primary Outcome Measures

Name	Time	Method
Pain : Premature Infant Pain Profile-Revised	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 Outcome Measures

Name	Time	Method
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	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).