Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04062513
• Other study ID #: MP-21-2020-2309
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2019
• Est. completion date: December 2020

Study information

• Verified date: August 2019
• Source: St. Justine's Hospital
• Contact: Gwenaelle De Clifford-Faugère, PhD student
• Phone: 514 343-6111
• Email: gwenaelle.de.clifford[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 29 Weeks to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Breast Milk
• Pain, Acute
• Premature Birth
• Preterm Infant

Intervention

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.
• Olfactive stimulation intervention
The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.
• Standard care
Preterm infants will receive sucrose during heel prick.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

References & Publications (2)

De Clifford-Faugère G, Aita M, Héon M, Le May S. Management of procedural pain in preterm infants through olfactive stimulation with mothers' milk: A pilot study. Science of Nursing and Health Practices - Science infirmière et pratiques en santé. 2(1), Article 3, 2019. Available at: https://doi.org/10.31770/2561-7516.1042

De Clifford-Faugère G, Lavallée A, Aita M. Olfactive stimulation interventions for managing procedural pain in preterm and full-term neonates: a systematic review protocol. Syst Rev. 2017 Oct 17;6(1):203. doi: 10.1186/s13643-017-0589-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection
Secondary	Recovery		The time required for the preterm infant to return to baseline heart rate levels (should not exceed 5 minutes)
Secondary	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).	Immediately post-procedure