Evaluation of the Effect of Use of Breast Milk Odor and White Noise on Pain Management During Heel Lance in Premature Newborns: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Physiological Findings
研究概览
简要总结
This study will conduct to evaluate the effect of using white noise and breast milk odor on pain during heel lance procedure in premature newborns. This study is a randomized controlled trial.
The study will conduct with premature newborns who were born between 34 and 37 weeks of gestation. The premature newborns will be divided into three groups by application of pain relief methods during heel lance to check blood sugar in newborns. These groups can be described as breast milk odor (n=22), white noise (n=22) and control group (n=22). The intervention will start 5 minutes before the procedure and last 5 minutes after the procedure. The infants will be recorded with a video camera by researcher before, during, and after the procedure. Premature Infant Pain Profile Revised (PIPP-R) will be used for pain grading.
详细描述
The sense of pain develops in infants after the 20th gestational weeks with the initiation of communication between the cortex and the thalamus. Babies in the newborn period can respond physiologically, behaviorally and hormonal to painful stimuli which they experienced. Responses that emerge as a result of pain experience may adversely affect the current state of the newborn and its growth and development in the long term. One of the painful procedures that the newborn is frequently exposed to at the beginning of the extra-uterine life is blood collection from the heel. Pharmacological and non-pharmacological methods can be applied to alleviate the pain sensation experienced by newborns during these procedures. The existence of possible side effects of pharmacological methods has led to need to use non-pharmacological methods more effectively. In this study, it was aimed to investigate the effectiveness of breast milk odor and white noise, which are non-pharmacological methods, to the pain caused by heel puncture.
Main hypothesizes of the study can be listed as:
H11: Breast milk smelling during heel lancing in preterm newborn infants effectively reduces the infant's procedure-related pain.
H01: Breast milk smelling during heel lancing in preterm newborn infants is not effective in reducing the procedure-related pain of the infant.
H12: Listening to white noise during heel lancing in preterm newborn babies effectively reduces the baby's procedure-related pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
A sponge soaked in saline was placed next to the babies listening to white noise, and a non-working loudspeaker was placed on the toe of the babies who smelled breast milk. The assessment was made by academics other than the researcher by muting the video recordings. The babies were considered blind because they did not know which group they were in.
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •gestational age between 34 and 37 weeks
- •birth weight over 1500 g
- •Taking blood from the heel for the purpose of measuring blood sugar
- •Starting feeding with breast milk
- •Parental consent
排除标准
- •Having a chromosomal abnormality
- •Presence of neonatal seizures
- •Presence of intracranial bleeding (grade III-IV)
- •Presence of craniofacial malformation
- •Presence of congenital hearing loss
- •Babies with perinatal asphyxia
- •Babies using sedatives, muscle relaxants and antiepileptics
- •Babies whose mothers have a history of substance use
结局指标
主要结局
Physiological Findings
时间窗: up to 7 days
Physiological Findings Follow-up Chart
Neonatal Pain
时间窗: up to 7 days
Premature Infant Pain Profile-Revised The scale includes seven criteria. Facial expressions (frown, squint, prominence of the nasolabial groove) represent three criteria. Two additional criteria are changes in heart rate and reduction in oxygen saturation. The remaining criteria are gestational week and behavioral status (active-awake, quiet-wake, active-asleep and quiet-sleeping). According to the scale, the highest score is 21 for prematures and 18 for term newborns. According to the scale scoring, 0-6 points indicate mild pain, 7-12 points moderate pain, and 13-21 points severe pain in a premature baby.
次要结局
未报告次要终点
研究者
Burcu Otlu
Principal Investigator
Ankara University