The Effect of Grasp Reflex Stimulation on Pain During Vaccine Administration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- pain level will be measured in the premature baby
研究概览
简要总结
Many painful interventions that cause pain and stress are applied to preterm babies in the neonatal intensive care unit for diagnosis and treatment. In neonatal care and reduction of acute interventional pain; Non-pharmacological methods including behavioral, psychological and environmental regulations should be used.
In the hepatitis B vaccine administered to preterm babies, stimulating the grasping reflex can make the preterm baby feel safe and calm. In the literature, there are many studies aimed at reducing pain in preterm newborns. However, no study has been found on the effect of grasping reflex stimulation on pain and crying in hepatitis B vaccine administration to preterm infants.
This study was planned to examine the effect of grasping reflex on pain and crying duration in preterm infants with hepatitis B vaccine.
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
- 28 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •28-36 gestational week
- •No congenital malformation
- •follow up with a diagnosis of respiratory distress syndrome,
- •receive oxygen support with a nasal cannula or tube,
- •not receive mechanical ventilation support,
- •no contraindications for hepatitis B vaccine administration,
- •stable vital signs before vaccination,
- •not receive analgesic sedation treatment
- •whose parents give verbal and written consent to participate in the study.
排除标准
- •Infants of parents who did not give informed voluntary consent will not be included in the study.
- •Decreased oxygen saturation levels
- •Tachycardia just before the vaccine administration
- •Invasive intervention in the right hand.
结局指标
主要结局
pain level will be measured in the premature baby
时间窗: 15 minutes
PIPP-R Form: The PIPP scale, developed by Stevens et al. in 1996, is a validated assessment tool used to evaluate acute pain experienced by preterm infants during interventional procedures (Stevens et al., 1996). This scale was revised by Stevens et al. in 2014 (Stevens et al., 2014). The PIPP-R was adapted into Turkish in 2019 (Taplak, \& Bayat, 2019). PIPP-R consists of behavioral subscales such as frowning, squeezing eyes, nasolabial furrow, physiological and behavioral status including heart rate and SPO2, and contextual subscales such as gestational age.
次要结局
- Crying time(15 minutes)
研究者
Türkan Kadiroğlu
Pricipal Investigator
Ataturk University