The Effect of 3 Different Auditory Applications on Pain, Crying Duration and Physiological Parameters During Newborn Heel Prick Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Cardiac apex beat (HRV)
研究概览
简要总结
In pain management of neonates in interventional applications, health professionals should be able to evaluate pain, reduce or eliminate pain. Pharmacologic and nonpharmacologic methods are used in pain management. Pharmacological, opioid analgesics, sedatives and local anesthetics are used. Nonpharmacologic methods include breastfeeding, giving pacifiers, oral sucrose, music, massage, therapeutic touch and nesting, positioning such as fetal positioning, wrapping, kangaroo care, rocking and cradling.
Music makes positive changes in oxygen saturation level and peak heart rate values and reduces stress and pain. Classical music with light rhythmic emphasis and steady rhythm accompanied by a simple human voice or a single instrument, music performed by female vocalists (mother's voice, lullabies with female voice) and white noise similar to intrauterine sounds are among the types of music that have a positive effect on newborns.
This study was planned as a randomized controlled experimental design to compare the lullaby, classical music and white noise song by the mother to the newborn before and during heel prick blood collection with the control group and to determine which application gives superior results to the newborn's pain level, crying time and physiological parameters.
详细描述
In pain management of newborns in interventional applications, health professionals should be able to evaluate pain and reduce or eliminate pain. Pharmacological and non-pharmacological methods are used in the management of pain. Non-pharmacological methods: practices such as breastfeeding, giving a pacifier, giving oral sucrose, listening to music, massage, therapeutic touching and nesting, positioning the fetus such as wrapping, giving kangaroo care, rocking and holding.
The newborn's response to sound often leads to changes in breathing and heart rate. Mild to moderate sounds (55-75 dB), such as speech and music, cause a decrease in heart rate and create an orientation response. Music makes positive changes in oxygen saturation level and heart rate peak values, and also reduces stress and pain. Arnon et al. determined that letting newborns in intensive care listen to music has a positive effect on reducing pain and anxiety, making it easier for newborns to fall asleep and increasing their sleep quality. Classical music with a light rhythmic emphasis and constant rhythm accompanied by a simple human voice or a single instrument, music performed by female vocalists (mother's voice, lullabies with a female voice) and white noise similar to intrauterine sounds are among the types of music that have a positive effect on newborns.
Heel prick pricking in newborns causes pain, which results in increased blood pressure and pulse rate, decreased SpO2, and crying. For this reason, this study was designed as a randomized controlled experimental design to compare the classical music and white noise and lullaby applications to the newborn before and during heel blood collection with the control group and to determine which application provides superior results on the newborn's pain level, crying duration and physiological parameters.
Research Purpose and Type This research was planned as a randomized controlled experimental design to compare the lullaby, classical music and white noise aplications to the newborn during the heel prick prick procedure with the control group.
Research Variables Independent variables; Lullaby your mother sings, white noise, classical music Dependent variables; Heart rate peak (HRV), oxygen saturation (SpO2), NIPS score, NIAPAS score, crying duration.
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
The baby's crying time will be monitored and recorded. KTA and SpO2 will be recorded by the researcher during blood collection. Pain assessment of the babies will be made by two independent neonatal nurses other than the researcher. Both observers must have worked in the clinic for at least 5 years.
Analysis of the data will be done by an independent analyst, not by researchers.
入排标准
- 年龄范围
- 24 Hours 至 72 Hours(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The newborn must be between 38-42 weeks and weigh appropriately for his/her week (Appropriate Gestational Age - AGA),
- •Not taking any analgesic, sedative or anticonvulsant medication for at least 6 hours before,
- •Feeding at least 1 hour before,
- •No fever,
- •Not receiving oxygen therapy,
- •Not receiving antibiotic treatment
- •No congenital anomalies
- •Not next to the bed or under the heater
- •Not receiving phototherapy,
- •Not being connected to a mechanical ventilator
排除标准
- •Presence of congenital anomaly,
- •Having a chest tube inserted,
- •Intracranial bleeding,
- •Presence of anomaly that may cause deafness
- •Those with a history of epileptic seizures will be excluded.
- •The patient's family refuses to participate in the study.
结局指标
主要结局
Cardiac apex beat (HRV)
时间窗: 5 minutes before heel blood collection and at 1, 3 and 5 minutes during heel blood collection.
HRV will be evaluated before and during heel blood collection. It will be recorded by the researcher during the blood collection process.
Oxygen saturation (SpO2)
时间窗: 5 minutes before heel blood collection and at 1, 3 and 5 minutes during heel blood collection.
SpO2 will be evaluated before and during heel blood collection. It will be recorded by the researcher during the blood collection process.
NIPS scale score
时间窗: NIPS will be evaluated 5 minutes before the heel prick and at 1, 3 and 5 minutes during the heel prick.
The scale is used to evaluate pain due to procedures performed in term and premature babies. NIPS consists of sections that evaluate 6 behaviors against pain (crying, breathing pattern, arm and leg movements and alertness). Although the total score varies between 0-7, a higher score indicates greater pain intensity.
NIAPAS scale score
时间窗: NIAPAS will be evaluated 5 minutes before the heel prick and at 1, 3 and 5 minutes during the heel prick.
NIAPAS scale measures acute pain; It is a scale that includes five behavioral and three physiological indicators given the week of gestation as a contextual factor. As a result of the scoring of the indicators, the score that can be obtained from the scale is between 0-18. Pain intensity is classified as mild pain (0-5), moderate pain (6-9) and severe pain (10-18).
Crying time
时间窗: The baby's crying time will be 5 minutes before the heel prick and 5 minutes during the heel prick.
The baby's crying time will be monitored and recorded.
次要结局
未报告次要终点
研究者
Zeynem YILDIRIM BALKAN
Dr. Lecturer and Principal Investigator
Namik Kemal University
