Effect of Bathing on Pain, Sleep and Vital Signs of Premature Babies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- sleep time
研究概览
简要总结
This study was conducted as a randomized controlled experimental study to determine the effect of bathing given to premature babies on pain, sleep and vital signs. The data of the study were obtained from premature newborns born at 34 weeks and above, who were hospitalized in Selcuk University Hospital Neonatal Intensive Care Unit between 1 June and 31 August 2020. The sample size was determined as 64 premature newborns. "Interview and Observation Form, Neonatal Pain/Agitation, Sedation Scale" was used for data collection. The data were evaluated with the SPSS 21.0 package program using percentage, mean, standard deviation, chi-square, t test, Anova and Tukey advanced analysis test.
The research was carried out in the following order. All permissions were obtained for data collection. Individual characteristics were obtained from family members and recorded in the questionnaire. Before the procedure, the pain levels of the newborns were evaluated and recorded. The status of babies in the study or control group was randomly determined according to the hospitalization day (www.randomizer.com).
The newborns in the study group were given a baby bath. The baby's body temperature, pulse, respiration, systolic and diastolic blood pressure, saturation, oxygen demand, and N-PASS scores were evaluated and recorded by two observers before the bath, at the 15th, 30th and 60th minutes after the bath.
No intervention was given to the newborns in the control group. However, body temperature, pulse, respiration, systolic and diastolic blood pressure, saturation, oxygen demand and N-PASS scores were evaluated and recorded in accordance with the measurement intervals of the newborns in the study group.
Cohen's kappa analysis was performed to assess interobserver agreement. Since the inter-observer agreement was found to be excellent (k=0.85), analysis was performed with an observer evaluation.
All newborns were measured at the same time of the day.
详细描述
The research will be carried out in the second and third level Neonatal Intensive Care Unit of X University Medical Faculty Hospital. 52 nurses and three neonatologists work in the unit. 12 nurses (in-clinical training nurse, nutrition nurse) work during the day and 10 nurses at night. The average number of babies per nurse for care is three. Second and third level patients are hospitalized in the clinic. The total number of beds is 45, with 36 beds at the third level and nine beds at the second level. The average number of babies admitted to the unit and treated is 55/550 monthly/yearly. (Due to the Covid 19 epidemic, the number of hospitalized patients is less than in previous years.)
Outside the unit, there are mother-baby adjustment rooms where the resting needs of mothers are met. There is no restriction on visiting hours for mothers in the clinic, mothers can see and take care of their babies whenever participants want 24/7. Before the Covid 19 epidemic, fathers had visiting hours, but during the epidemic, father visits were abolished.
The sample size was calculated with the G*Power 3.1.5 program with 95% power and 10% difference at 0.05 significance level. The sample size was determined as 64 newborns, 32 children for each group. At the end of the study, Post Hoc power analysis will be performed in order to determine the adequacy of the number of newborns included in the study. When it is determined that 95% power is reached, the data collection process will be terminated.
Randomization of control and study groups; The status of the children to be included in the study in the control or study group will be determined by using "stratification and randomization methods with blocks", taking into account the hospital registration numbers and gender of the newborns. Accordingly, children will be stratified as "girls and boys" for the gender variable. 32 premature newborns will be included in each of the research groups. Since the newborns and their families do not meet each other during the data collection process, the interaction of the newborns in the study and control groups with each other will be prevented.
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 (Participant)
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The gestational age of the baby is 34 weeks and above
- •Ability to maintain body temperature
- •No contraindication for post-surgical bathing
- •Not using any analgesic medication
- •Body weight of 2000 g and above
- •Baby's oxygen need is less than 30%
- •No nutritional intolerance
- •Parents' willingness to participate in the research
排除标准
- •The gestational age of the premature baby is less than 34 weeks.
- •Inability to maintain body temperature
- •Contraindication of bathing
- •Body weight less than 2000 g
- •Oxygen requirement greater than 30%
- •Presence of nutritional intolerance
- •Contraindication of bathing due to clinical course
- •Parents' refusal to participate in the study
结局指标
主要结局
sleep time
时间窗: two hours
Measuring the sleep time of the newborn with a stopwatch evaluation
Blood pressure
时间窗: 60 minutes
Evaluation of the change in blood pressure of the newborn at 15, 30 and 60 minutes after the bath, with a sphygmomanometer just before the bath, according to the baseline value.
oxygen saturation
时间窗: 60 minutes
Evaluation of the change in oxygen saturation of the newborn 15, 30 and 60 minutes after the bath, with a saturation device just before the bath, according to the initial value.
Pain Score
时间窗: 60 minutes
Evaluation of the change in the pain status of the newborn according to the initial value with Neonatal Pain Agitation And Sedation Scale (N-PASS) just before the bath, 15, 30 and 60 minutes after the bath. N-PASS, which consists of two separate sections measuring the sedation level and pain level of the baby; It consists of 5 sub-parameters including crying and restlessness, behavior-state, facial expression, hands and feet, body tension and vital signs. A score between 0 and +2 is given for each behavioral and physiological criterion in the evaluation of pain, and between 0 and -2 in the evaluation of sedation. If the baby was born before 30 weeks of gestation, +1 point is added to the total score in the pain assessment. The total pain score ranges from 0 to +11, and the total sedation score ranges from 0 to 10. A high score indicates that the severity of pain is high.
body temperature
时间窗: 60 minutes
Evaluation of the change in the temperature of the newborn according to the initial value with a thermometer 15, 30 and 60 minutes after bathing, just before bathing.
pulse rate
时间窗: 60 minutes
Evaluation of the newborn's heart rate 15, 30 and 60 minutes after bathing, with a thermometer just before bathing, according to the baseline value.
respiratory rate
时间窗: 60 minutes
Evaluation of the change in the respiratory rate of the newborn at 15, 30 and 60 minutes after the bath, by observation (during 1 minute) just before the bath, relative to the baseline value.
次要结局
未报告次要终点
研究者
Ayse Sonay Turkmen, Assoc. Prof
Assoc.Prof.
Karamanoğlu Mehmetbey University