The Effect of White Noise on Pain and Stress Level in Nasal Cpap Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 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
The aim of this study is to determine the effect of white noise application on the pain and stress level of newborns receiving oxygen support via nasal CPAP in the Neonatal Intensive Care Unit. The research is a randomized controlled trial. The population of the study will be infants aged 0-28 days who were hospitalized for treatment in Şanlıurfa Training and Research Hospital between July and December 2022. The research sample; Babies of families who are hospitalized in the Neonatal Intensive Care Unit on the specified dates and meet the research criteria and volunteer to participate in the research will be formed. "Survey Form", "Follow-up Form" and "ALPS Neo Neonatal Pain and Stress Assessment Scale", White Noise, MP 3 Player, and Sound Decibel Measuring Device will be used to collect data.
详细描述
Type of Study: The study is planned experimentally with a randomized control group.
Place and Time of the Research: The research will be carried out between June-December 2022 in Şanlıurfa Training and Research Hospital Neonatal Intensive Care Unit. There are 130 incubators in total, with 53 beds at the 2nd level and 54 beds at the 3rd level. 55 respirators, 4 fully equipped transport incubators with respirators, isolation room, 4 hypothermia devices, 2 Aeeg devices etc. are available. Treatments that can be performed in the Neonatal Intensive Care Unit; respiratory support (ventilator therapy), thoracic tube insertion, blood exchange, total parenteral nutrition, phototherapy, percutaneous catheter applications, patient transport with 24-hour incubators with breathing apparatus, dialysis catheter insertion and follow-up, colostomy care, etc. are treatments. A total of 133 nurses work.
Population and Sampling of the Study: The population of the study will consist of infants aged 0-28 days who will receive oxygen therapy in nasal CPAP by being hospitalized in the Newborn Intensive Care Unit of Şanlıurfa Training and Research Hospital between July and December 2022 due to respiratory distress.
In this study, "prior power analysis" was used to determine sample adequacy. In the power analysis used, "Cohen's standard effect size reference technique" was chosen. In this case, for the t-test in independent groups, it was determined that if the study was advanced with 80 participants in two groups with 40 participants in each group, 80% power could be reached at a significance level of 0.05, at a 95% confidence interval. Against the possibility of data loss, it was decided to collect data from a total of 100 individuals by adding 10% more backup sample to this number. In order to ensure randomization, babies who meet the criteria will be taken to the control group, who are in the first week, and to the experimental group, respectively, and this cycle will be continued until the end of the research, and randomization will be ensured.
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
- 38 Weeks 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •38-40 weeks of gestation
- •Receiving oxygen support in nasal CPAP
- •Not taking opioids or sedatives 4 hours before the procedure
排除标准
- •Not at 38-40 weeks of gestation
- •Not receiving oxygen support in nasal CPAP
- •Taking opioids or sedatives 4 hours before the procedure
研究组 & 干预措施
White Noise
white noise will reduce pain and stress
干预措施: white noise (Behavioral)
control
white noise will not reduce pain and stress
结局指标
主要结局
ALPS Neo Neonatal Pain and Stress Rating Scale
时间窗: 9 MONTHS
The "ALPS Neo Neonatal Pain and Stress Rating Scale" was developed in 2014, 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 its validity and reliability study was conducted. The scale is a 3-point Likert-type scale consisting of 5 parameters: "newborn's facial expression, breathing pattern, tone of the extremities, hand/foot activities, and activity level". As the scores 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