The Effect of Facilitated-tucking, ShotBlocker, and the Combination of the Facilitated-tucking and ShotBlocker on Pain Caused by Hepatitis-B Vaccination in Healthy Term Infants: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Neonatal Infant Pain Scale
研究概览
简要总结
This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants.
详细描述
Hepatitis B vaccination is one of the painful procedures routinely performed in newborns. The pain experienced by the newborn negatively affects the prognosis of the disease, the infant's behavior, the harmony with the environment, the development of the brain and senses, as well as the family-infant interaction. Nonpharmacologic methods have been found to be effective in alleviating pain during interventions that cause pain caused by medical procedures that newborns frequently encounter. Facilitated tucking and ShotBlocker are effective methods that can be used in nonpharmacologic procedural pain management.
Studies have commonly used parent-related methods (kangaroo care, mother/father cuddling, breastfeeding, etc.) for neonatal pain management during Hepatitis B vaccine administration. In units where access to the parent is not always possible, nonpharmacologic pain methods that can be used independently of the parent can be used in the management of acute needle-related pain. In addition, no study was found in the literature comparing and combining the effect of fetal position and ShotBlocker application on hepatitis B vaccine-related pain. This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants.
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
Using the block randomization technique, participants will be divided into 4 groups. A web-based randomization list creation tool will be used to create the blocked randomization list. Control and intervention groups will be coded as A, B, C and D using the sealed envelope method. Randomization information will be kept from the researcher involved in data collection until data collection begins. The researcher will learn which group each baby is in just before the application (researcher blinding).
Parents will know which group the baby is in within the scope of the research. By the nature of the sample group, babies are blind.
Research data will be entered into the computer database by coding the group name as A, B, C and D, and statistical analysis will be performed using this coding (statistician blinding).
入排标准
- 年龄范围
- 38 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy term neonates
- •born at 38-42 weeks gestational week,
- •birth weight 2500-4400 g,
- •5th minute APGAR score above 6,
- •in stable health,
- •able to carry out vital activities without support,
- •babies ordered Hepatitis B vaccine by the doctor
排除标准
- •With a genetic or congenital anomaly,
- •neurological, cardiological and metabolic diseases,
- •in need of respiratory support,
- •acute or chronic illness that causes pain,
- •a complication of childbirth,
- •infants of hepatitis B carrier mothers,
- •nerve damage or deformity in the extremity to be vaccinated, scar tissue or incision in the vastus lateralis region,
- •infants of mothers with a history of substance abuse
结局指标
主要结局
Neonatal Infant Pain Scale
时间窗: 1 min before, during, 1 min after and 3 min after the painful procedure, an average of 4-5 minutes
The scale is used to assess procedural pain in neonates. It is a behavioral scale assessing five behavioral indicators (facial expression, cry, arms, legs, and state of alertness) and one physiological indicator (breathing patterns). Five items (facial expression, breathing pattern, arms, legs, and state of alertness) are scored as 0 (Good) or 1 (Bad), while one item (crying) is scored as 0 (Good), 1, or 2 (Bad). The total scale score ranges from 0 to 7, with higher scores indicating more pain.
次要结局
- Crying time during the procedure(Through painful procedure completion, an average of 4 minutes)
- Procedure time(Through painful procedure completion, an average of 60 seconds)
研究者
Aynur Aytekin Ozdemir
Professor
Istanbul Medeniyet University