Comparison of the Efficacy of Non-pharmacological Interventions on Pain Levels, Crying Times and Voice Decibels in Newborns: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Crying times
研究概览
简要总结
This study aimed to investigate and compare the effects of different non-pharmacological interventions (kangaroo care, holding on mother's lap, white noise listening, ambient sound listening) on newborns' crying times, voice decibels and pain levels during heel-stick procedure
详细描述
The study is a prospective, randomized controlled trial including pre and post tests of four groups. The population of the study consisted of newborns who were followed in the Neonatal Service of Eskişehir City Hospital. The number of newborns to be sampled was determined by power analysis. With a 95% confidence interval, 0.25 effect size and 0.85 strength, 34 newborns are planned to be included in each group. Newborns who meet the inclusion criteria will be randomly assigned to the groups.
In the randomization process; in the four-group design, the rooms were randomly assigned to the study groups by drawing lots in order to eliminate the probability of influence of newborns from each other. Internal blinding was used as a blinding method in order to ensure complete randomization and to prevent Rosental effect. The randomization was performed by the responsible nurse of the unit who was unaware of the pre-test and post-tests of the application.
- Four different groups were formed in order to prevent the causes of concern in the randomization of patients who were leveled according to their clinical status in the neonatal intensive care unit.
- In the absence of neonatal intensive care environment noise, four groups were considered due to the limitation in explaining the benefit, contribution and effect of white noise, kangru care and being in the lap of the mother in reducing pain.
- The newborns treated with kangaroo care and the mother's lap will be the control groups of each other and the newborns treated with white noise and ambient sound will be the control groups of each other.
Research hypotheses:
H1. Newborns receiving kangaroo care during the heel-stick procedure have lower pain levels than newborns who are holding on their mother's lap.
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
- None
入排标准
- 年龄范围
- 1 Day 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestation age is between 34-42 weeks
- •Birth weight is between 2500-4000 gr
- •Apgar score of 1 minute and 5 minutes 8 and above
- •Passing the newborn hearing screening test
- •To being followed in the neonatal intensive care unit
- •To being fed at least half an hour before the procedure
- •To being agreed to participate in the study by parents
- •To being never received mechanical ventilation / CPAP support after birth
- •Having none of congenital anomaly
排除标准
- •Inability to take blood the first attempt, as the pain level may change
- •Failure of the newborn to pass the hearing screening test
- •Newborns hospitalized from polyclinic and emergency department because heel blood was taken before
- •Refusing to participate in the study by parents
研究组 & 干预措施
Kangaroo care
Heel stick procedure will be performed during kangaroo care.
During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure.
干预措施: kangaroo care (Other)
Mother's lap
Heel stick procedure will be performed during newborns who are holding on their mother's lap.
During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure.
干预措施: holding on the mother's lap (Other)
White noise
Heel stick procedure will be performed during newborns listened to white noise.
For the white noise; the track named "do not cry your baby, pt. 2" will be played in Orhan Osman's Colic album. The white noise level will be adjusted to an average of 55 decibels. During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure.
干预措施: white noise listening (Other)
Ambient sound
Heel stick procedure will be performed during newborns listened to ambient sound.
During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure.
干预措施: ambient sound listening (Other)
结局指标
主要结局
Crying times
时间窗: Five months
Newborns' crying times during heel-stick procedure will be assessed with the stopwatch
Voice decibels
时间窗: Five months
Newborns' voice decibels during heel-stick procedure will be assessed with the sound decibel meter
Pain levels
时间窗: Five months
Newborns' pain levels during heel-stick procedure will be assessed with NIPS (Neonatal Infant Pain Scale)
次要结局
未报告次要终点
研究者
Pınar Duru
Principal Investigator
Eskisehir Osmangazi University