The Effect of Breast Milk Odor on the Pain and Stress Level of the Newborn During the Endotracheal Aspiration Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- ALPS Neo Neonatal Pain and Stress Rating Scale
研究概览
简要总结
Our study aims to determine the effect of breast milk odor on pain and stress in the application of endotracheal aspiration in newborns hospitalized in the Neonatal Intensive Care Unit. The research is planned experimentally with a pretest posttest randomized control group. The research will be carried out in Şanlıurfa Training and Research Hospital Neonatal Intensive Care Unit between March-December 2022. The population of the study will consist of patients aged 30-28 days who were hospitalized in the Şanlıurfa Training and Research Hospital Neonatal Intensive Care Unit between March-December 2022 and received mechanical ventilation treatment.
The research sample; Babies of families who are hospitalized on the dates specified with the probability sampling method and meet the research criteria and volunteer to participate in the research will be formed. Questionnaire Form, Neonatal Pain and Stress Assessment Scale, and Follow-up Form will be used to collect research data. The scent of breast milk will be used as an intervention tool in the research.
详细描述
3.1. Type of Research The research is planned experimentally with a pretest posttest randomized control group.
3.2. Place and Time of Research The research will be carried out in Şanlıurfa Training and Research Hospital Neonatal Intensive Care Unit between March-December 2022.
3.3. Population and Sample of the Research The population of the study will consist of patients aged 30-28 days who were hospitalized in the Şanlıurfa Training and Research Hospital Neonatal Intensive Care Unit between March-December 2022 and received mechanical ventilation treatment.
The research sample; Babies of families who are hospitalized on the dates specified with the probability sampling method and meet the research criteria and volunteer to participate in the research will be formed. In this study, a priori power analysis was performed to determine the sample size. In the power analysis, Cohen's standard effect sizes reference method was chosen. In this case, in our study, for the t-test in independent groups in which the effect of sniffed breast milk on endotracheal aspiration application will be compared, it was determined that "80% power at the 95% confidence interval at the 0.05 significance level" could be reached if the study was conducted with a total of 80 participants in two groups with 40 participants in each group. In case of data loss, it was decided to collect data from a total of 88 individuals by including 10% backup sample to this number. Data will be collected at different times from newborns receiving invasive mechanical ventilation support in incubators in the Neonatal Intensive Care Unit. There is no interaction between the groups.
Inclusion Criteria for Research
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
- Single (Investigator)
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being a term newborn,
- •to be between 0-28 days,
- •Receiving mechanical ventilation support,
- •Not taking opioids or sedatives 4 hours before the procedure.
排除标准
- •not be between 0-28 days,
- •Not receiving mechanical ventilation support,
- •Taking opioids or sedatives 4 hours before the procedure.
研究组 & 干预措施
SMELL OF BREAST MILK
the smell of breast milk will reduce pain and stress
干预措施: the smell of breast milk (Behavioral)
control
pain and stress will not decrease
结局指标
主要结局
ALPS Neo Neonatal Pain and Stress Rating Scale
时间窗: 9 MONTHS
In 2014, the "Newborn Pain and Stress Rating Scale" was developed based on the individualized developmental care of the newborn in order to evaluate pain and stress in premature and term newborns. In 2017, this scale was adapted to Turkish and validity and reliability studies were conducted. ALPS Neo "Newborn Pain and Stress Assessment Scale" is a 3-point Likert-type scale consisting of 5 items, including "facial expression, breathing pattern, tone of extremities, hand/foot activities and activity level" of the newborn, and measurements are made by observation. As the scores obtained increase, pain and stress increase in the newborn. As a result of the evaluation, "3-5 points indicate the presence of mild pain and stress, and more than 5 points indicate the presence of severe pain and stress".
次要结局
未报告次要终点
研究者
ARZU SARIALİOĞLU
Principal Investigator
Ataturk University