The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters During Vaccine Injection in Babies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- SpO2
研究概览
简要总结
The aim of this study is to determine the effect of ShotBlocker© and cold massage on pain, crying time and physiological parameters during DaBT-IPA-Hib vaccine administration in 2-6 months old babies.
详细描述
The aim of this study is to determine the effect of ShotBlocker© and cold massage on pain, crying time and physiological parameters during DaBT-IPA-Hib vaccine administration in 2-6 months old babies.This study was planned as randomized controlled experimental single-blind.
The population of the research will be 2-6 months old babies who come to Giresun Güce District State Hospital Family Health Center to receive DaBT-IPA-Hib vaccine between the dates of the research. The sample of the study will consist of infants who met the case selection criteria, accepted to participate in the study and were vaccinated between the specified dates.
As a result of the power analysis, it was determined that a total of 99 infants, 33 of whom were to be applied cold massage, 33 to be administered ShotBlocker©, and 33 to the control group, who were 2-6 months old to be administered DaBT-IPA-Hib vaccine, met the case selection criteria and agreed to participate in the study. Considering the possibility of case losses, a total of 108 babies, 36 in each group, are planned to be included in the study.
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
- Double (Participant, Outcomes Assessor)
盲法说明
In order to prevent selection bias, the assignment of infants to groups will be made using "stratification and randomization methods with blocks". Parents will not be informed which group their baby is in (ShotBlocker©, cold massage, control). In the study, the pain level of the infants will be evaluated by the family health worker, the researcher and their parents who administered the vaccine. At the end of the study, inter-observer agreement will be evaluated. Parents and family health workers will be informed by the researcher about the pain scale to be used in the research. In addition, the database of the research will be created by a university graduate statistician working in a statistical center independent of the research, apart from the researcher.
入排标准
- 年龄范围
- 2 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The baby is 2-6 months old,
- •DaBT- IPA- Hib vaccine will be administered,
- •The baby does not have a chronic disease,
- •Parents must be at least primary school graduate,
- •Parent's willingness to participate in the study.
排除标准
- •Having a congenital or neurological health problem,
- •Have taken an analgesic drug in the last 4 hours,
- •Babies with a body temperature above 37.5 will not be included in the study.
结局指标
主要结局
SpO2
时间窗: 1 minute after the procedure
Physiological parameters
Pulse
时间窗: 1 minute after the procedure
Physiological parameters
FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale)
时间窗: 1 minute after the procedure
The FLACC scale was first developed by Merkel et al.in 1997. In the research, it will be used to evaluate the pain levels of infants in the experimental and control groups before, during and after vaccination. The five behaviors ("face", "legs", "activity", "crying" and "consolation") evaluated on this scale are considered indicators of pain that can be detected and graded by an observer. Descriptors for each item are accepted as indicators of children's painful behavior. Each item is scored from 0 to two, resulting in a pain intensity score ranging from 0 to 10. And descriptors associated with each score level represent pain intensity.
Body temperature
时间窗: 1 minute after the procedure
Physiological parameters
crying
时间窗: 1 minute after the procedure
crying time will be measured and noted.
次要结局
未报告次要终点
研究者
Dilek Kucuk Alemdar
Associate professor
T.C. ORDU ÜNİVERSİTESİ