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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olfactive stimulation intervention with familiarization | Experimental | 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. |
|
| Olfactive stimulation intervention | Experimental | Participants will receive the olfactive stimulation intervention with mothers' milk odor during heel prick only. Sucrose will be also administered during heel prick. |
|
| Standard care | Other | In the control arm, participants will receive the standard care for pain which is sucrose administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olfactive stimulation intervention with familiarization | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). |
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Inclusion Criteria for mothers
Exclusion Criteria for mothers
- pathology or condition that contraindicates the use of their breast milk (HIV, drugs...)
Inclusion Criteria for preterm
Exclusion Criteria for preterm
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gwenaelle De Clifford-Faugère, PhD student | Contact | 514 343-6111 | 51473 | gwenaelle.de.clifford@umontreal.ca |
| Marilyn Aita, PhD | Contact | 514 343-6111 | 51473 | marilyn.aita@umontreal.ca |
| Name | Affiliation | Role |
|---|---|---|
| Marilyn Aita, PhD | Université de Montréal | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29041964 | Background | De Clifford-Faugere G, Lavallee 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. | |
| Background | 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 |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Olfactive stimulation intervention | Other | The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick. |
|
| Standard care | Other | Preterm infants will receive sucrose during heel prick. |
|
| Immediately post-procedure |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |