The Effect of Giving a Pacifier Dipped in Breast Milk, Heel Warming, and Applying Both Together on Pain and Salivary Cortisol Levels During Heel Stick in Preterm Newborns: Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 主要终点
- Cardiac apex beat (HRV)
研究概览
简要总结
Babies born before the thirty-seventh gestational week are called preterm or premature. Most preterm newborns require Neonatal Intensive Care Unit (NICU) care depending on their gestational age and clinical condition. Although many painful invasive procedures are usually performed on newborns in the NICU, the most common procedure is heel prick. Heel prick is a painful and stressful procedure for the newborn. Neonates do not respond to pain verbally; they respond physiologically, behaviorally and hormonally. Physiologic responses of preterm infants to pain include increased heart and respiratory rate, increased blood pressure and intracranial pressure, decreased oxygenation, and sweating of palms. Among the hormonal symptoms caused by stress in newborns, the most commonly used biochemical method is the measurement of cortisol level. It is reported that there is a significant correlation between salivary and plasma cortisol levels and salivary cortisol level reflects plasma cortisol level. This method is particularly preferred because saliva sampling is much less stressful.
详细描述
Health professionals should be able to evaluate pain, reduce or eliminate pain in pain management of neonates in interventional applications. Pharmacologic and nonpharmacologic methods are used in pain management. When these methods are applied together, their effectiveness increases in pain related to invasive interventions. Pharmacologically, opioid analgesics, sedatives and local anesthetics are used. Nonpharmacologic methods include breastfeeding, pacifier, oral sucrose, music, warm application, massage, therapeutic touch and positioning such as nesting, fetal positioning, swaddling, kangaroo care, rocking and holding.
In many studies, nonpharmacologic interventions have been applied and compared to reduce pain during heel prick in preterm newborns. In the routine of the clinic, heel prick blood collection from preterm newborns is performed by hugging the mother in her lap. The swaddling procedure for preterm newborns in the control group is recommended by the American Academy of Pediatrics. The swaddling method supports flexion and lateral posture, which is the developmental position of the newborn. With this position, the newborn comes to its position in the uterus, which is familiar to it, ensuring its physiological stability and improving its capacity. In a systematic review of 3396 participants, preterm newborns were calmed and immediately stabilized by kangaroo care, non-nutritive sucking and swaddling methods. Since these methods reduce pain and stress in preterm newborns, they are also reported to be included in "Individualized Supportive Developmental Care" practices.
Many studies have shown that giving pacifiers to newborns is effective in reducing pain. In addition, oral administration of breast milk alone, without breastfeeding, has been found to reduce pain during heel prick, nasopharyngeal aspiration, venipuncture and retinopathy examination in preterms. In the study conducted by Lan et al., breast milk was sniffed to the newborn during heel prick blood collection or tasted by dropping into the newborns mouth with a syringe. As a result, they reported that sniffing and plus tasting breast milk was effective in alleviating pain in newborns.
In the literature, it is emphasized that the pain that occurs during heel blood collection is closely related to the squeezing of the heel to collect blood, not during the needle insertion into the heel, and it is thought that keeping the newborn in an upright position during heel blood collection may facilitate blood flow through gravity and reduce the amount of squeezing required to obtain the sample. However, there are studies showing that heel warming is effective in reducing pain in newborns. It has been stated that with warm application to the heel -with the effect of vasodilation- fewer needling is performed in the heel, the amount of blood required for the procedure increases and the procedure is completed in a shorter time. It is predicted that the heel of the newborn will be squeezed less thanks to the warm application.
However, there is a very limited number of studies evaluating the effectiveness of different nonpharmacologic interventions during heel prick blood collection and measuring the stress marker cortisol. In addition, no study was found to investigate the effectiveness of other interventions (heel warming and giving a pacifier dipped in breast milk) in combination with wrapping among nonpharmacological interventions.
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)
盲法说明
The same neonatal nurse with at least 5 years of experience will perform the interventions.
Salivary cortisol sample will be taken by the same investigator with 5 years of experience.
Salivary cortisol analysis will be performed in the laboratory by biochemistry specialists who have not seen the interventions performed on the newborn.
Babies will be video recorded before, during and after the procedure.
Video recordings will be monitored and recorded by 2 independent investigators.
Data will be analyzed by an independent statistician other than the researchers.
入排标准
- 年龄范围
- 34 Weeks 至 36 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother 18 years of age or older
- •Mother is literate
- •Whether the mother gives birth naturally or by caesarean section
- •Uncomplicated pregnancy and birth history in mother
- •Mother's voluntary participation in the study
- •Preterm babies between 34 0/7-36 6/7 weeks
- •Prematurity at 34 0/7-36 6/7 weeks and weight appropriate for the week (Appropriate Gestational Age- AGA),
- •The baby should be fed at least 1 hour in advance.
- •It has been 1 hour since the last painful intervention on the baby.
- •6Heel blood should be taken 6 hours after taking analgesic, sedative and anticonvulsant medications.
排除标准
- •The baby has a fever
- •The baby receiving oxygen therapy,
- •The baby receiving antibiotic treatment
- •The baby has a congenital anomaly
- •The baby having the bed side and heater underneath
- •The baby receiving phototherapy,
- •The baby is connected to a mechanical ventilator
- •Babies whose blood was not collected on the first attempt
结局指标
主要结局
Cardiac apex beat (HRV)
时间窗: Through study completion, an average of 1 year.
HRV will be evaluated before, during and after the heel blood collection. Each baby will be video recorded for 7-10 minutes before, during and after the procedure by the researcher.
Oxygen saturation (SpO2)
时间窗: Through study completion, an average of 1 year
SpO2 will be evaluated before, during and after the heel blood collection. Each baby will be video recorded for 7-10 minutes before, during and after the procedure by the researcher. SpO2 will be recorded from this video recording.
Crying time
时间窗: Through study completion, an average of 1 year
The baby crying time will be monitored and recorded 5 minutes before the heel prick and 5 minutes during the heel prick
Premature Infant Pain Profile Scale (PIPP-R)
时间窗: Through study completion, an average of 1 year
The PIPP-R scale includes 3 behavioral (frowning, squeezing eyes, nasolabial groove), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral state and gestational age) items. In the scoring of the scale, items related to physiological and behavioral items are scored as 0,1,2,3 in each variable, reflecting the difference between baseline and treatment values. Items related to contextual items are scored as 3,2,1,0 before touching the baby. The babys pain is evaluated on a total score. Accordingly, the maximum score for newborns is 21. If the premature infant pain profile is between 0-6 points, the pain level in the infant is mild, between 7-12 points is moderate, and between 13-21 points is severe pain. Each baby will be video monitored and recorded for 7-10 minutes before, during and after the procedure. This video recording will be evaluated and recorded according to the Premature Infant Pain Profile Scale.
Salivary cortisol level
时间窗: Through study completion, an average of 1 year
Since cortisol shows circadian rhythm in premature infants, samples will be taken at the same time in the morning. Before taking saliva samples, the newborns mouth will be checked and oral care will be given with SF. Saliva samples will be collected with the Salimetrics Salivary Cortisol Kit by holding it in the cheek and sublingual cavity of the newborn for 1-2 minutes. The samples will be sent to the biochemistry laboratory of the research hospital. The samples will be analyzed for quantitative determination of cortisol by 2 biochemistry experts using standard procedures in the Biochemistry laboratory of TNKU Hospital. Samples will be taken twice, both during the procedure and 25 minutes after the procedure (the highest cortisol level after pain in newborns is detected between 20-30 minutes after the procedure).
次要结局
未报告次要终点
研究者
Zeynem YILDIRIM BALKAN
Assistant Professor and Principal Investigator
Namik Kemal University
