Effect of Gentle Human Touch and Kangaroo Care Applied During Hepatitis-B Vaccination in Newborns on Pain, Crying Duration and Physiological Parameters: 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
- 80
- 试验地点
- 2
- 主要终点
- pain level
研究概览
简要总结
Many short- and long-term consequences, including altered physiological parameters, issues with feeding and sleep, chronic pain syndrome, difficulty focusing, anxiety, cognitive behavioral disorders, adjustment disorders, and growth retardation, have been linked to pain in neonates. Each and every newborn is entitled to pain relief and reduction. Avoiding painful interventions is the most crucial tactic in the management of newborn pain. However, it is impossible to ignore the necessity of therapeutic and diagnostic interventions. As such, pain reduction and elimination are crucial. Non-pharmacological techniques used on infants undergoing invasive operations have been shown in studies to be successful in reducing discomfort, pain, and restlessness while also enhancing comfort.
Numerous non-invasive, non-pharmacological techniques are employed for this goal. Among the non-invasive, non-pharmacological techniques include breastfeeding, nursing, therapeutic touch, skin-to-skin contact, wrapping, swaddling, music therapy, and white noise. The Hepatitis-B vaccine is among the first invasive therapies administered to infants. Research indicates that pain scores are positively impacted by canopy touch. Skin-to-skin contact is achieved by a number of techniques. The most popular is kangaroo care, which is given to mothers nude on their chests. Gentle human touch is another technique used to lessen pain during invasive operations (GHT). GHT is a soothing tactile stimulation that doesn't involve touching or rubbing. Several research have examined GHT's impact and discovered that it effectively reduces pain.
The purpose of this study was to ascertain how GHT and Kangaroo care affected the newborn's pain, length of crying, and physiological parameters while the Hepatitis-B vaccine was being administered. The researchers at the Kirsehir Training and Research Hospital in Turkey will apply their findings to healthy newborns who are placed adjacent to their moms in the postpartum ward. The researchers have experience in neonatal critical care nursing and are qualified in therapeutic touch.
详细描述
After birth, the fetus undergoes a process of transformation from its diverse physiological and anatomical state during the intrauterine period. During the first 28 days of life, every newborn's bodily systems and functions continue to evolve in an effort to adjust to the extrauterine world.
With the right treatment, extrauterine adaption can be ensured for the newborn during this dangerous time. Many invasive procedures for diagnosis and prevention are part of healthy newborn care, and they are crucial for maintaining health once early extrauterine adaption is achieved. These invasive procedures include blood sugar testing, intramuscular injections, heel blood collection, and blood collection from peripheral veins.
Contrary to popular assumption, neonates have more sensitive pain perception, and it is well recognized that discomfort in newborns can lead to a variety of issues. The American Academy of Pediatrics states that pain is an unpleasant emotional and sensory experience brought on by actual or anticipated texture.
Infants experience pain to the same extent as adults do. So much so that pain in babies has been linked to a wide range of both immediate and long-term consequences, including altered physiological parameters, issues with nutrition and sleep, chronic pain syndrome, difficulty focusing, anxiety, cognitive behavioral disorders, adjustment disorder, and growth retardation. Each and every newborn is entitled to pain relief and reduction.
Avoiding painful interventions is the most crucial tactic in the management of newborn pain. It is impossible to avoid the necessity for therapeutic and diagnostic procedures, though. As such, pain reduction and elimination are crucial. According to studies, non-pharmacological techniques used on infants undergoing invasive operations are successful in reducing discomfort, pain, and restlessness while enhancing comfort. Numerous non-invasive, non-pharmacological techniques are employed for this goal. Among the non-invasive, non-pharmacological techniques include breastfeeding, nursing, therapeutic touch, skin-to-skin contact, wrapping, swaddling, music therapy, and white noise.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational week between 38-42,
- •Born at 38 weeks or above and with a body weight of >2500 grams,
- •Apgar score 1st and 5th 7 and above per minute,
- •Mothers who speak and speak Turkish
排除标准
- •Congenital anomaly
- •Hospitalization of the baby in the neonatal intensive care unit after birth
- •Mothers with hepatitis B vaccine refusal
- •Mothers who do not have kangaroo care
结局指标
主要结局
pain level
时间窗: before vaccination/ immediately after vaccination
The newborn's pain assessment will be measured by NIPS. In the scale, the baby's facial expression (0-1 point), crying (0-2 points), breathing pattern (0-1 point), arm movements (0-1 point), leg movements (0-1 point) and alertness ( Scores between 0-7 are given according to 0-1 points). An increase in the score on the scale indicates a higher severity of pain.
次要结局
- newborn crying duration(immediately after vaccination)
- Respiratory rate(before vaccination/ immediately after vaccination)
- Heart rate(before vaccination/ immediately after vaccination)
- Saturation(before vaccination/ immediately after vaccination)
研究者
Elif Tuba KOC
Child Health and Diseases Nursing Department President
Kirsehir Ahi Evran Universitesi