Effectiveness of Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 主要终点
- Pain : Premature Infant Pain Profile-Revised
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 29 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for mothers
- •18 years or older,
- •speak, understand and write French or English
- •express their milk
排除标准
- •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
结局指标
主要结局
Pain : Premature Infant Pain Profile-Revised
时间窗: 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.
次要结局
- 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)
研究者
De Clifford-Faugère Gwenaelle
Principal investigator
St. Justine's Hospital