The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates: A Randomized Controlled Trial
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
- Procedural pain score- Neonatal Infant Pain Scale (NIPS)
研究概览
简要总结
This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants.
详细描述
Heel prick blood collection, which is one of the painful medical procedures, is one of the diagnostic methods used in newborns and is a more painful procedure compared to other blood collection procedures. Prevention of pain in newborns should be the primary goal of all healthcare personnel working with newborns, both because it is an ethical obligation and because repeated painful exposures have the potential to cause harmful consequences. Nonpharmacologic methods used for the control of acute pain associated with medical procedures are easy to use, have no side effects, are inexpensive and time-saving. Mechanical vibration and ShotBlocker application are among the non-pharmacologic methods frequently used in the management of pain associated with heel prick procedure in term infants.
Previous studies have shown that parent-related methods (kangaroo care, mother/father hug, breastfeeding, etc.) are commonly used for pain management of the newborn during heel prick. In this respect, it is important to determine the effectiveness of mechanical vibration and ShotBlocker methods that can be used independently of the parent, especially in intensive care settings where access to the parent is not always possible.
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 were divided into three groups. A web-based randomization list generation tool was used to assign participants to groups. Control and intervention groups were coded as A, B and C using the sealed envelope method. Randomization information was withheld from the researcher involved in data collection until data was collected. The researcher determines which group each baby is in. The researcher found out during the painful procedure. (investigator blinding).
Within the scope of the research, parents knew which group the baby was in. However, due to the nature of the sample group, the babies were blind.
To avoid statistical bias, study groups were coded as A, B and C; statistical blinding was performed (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
- •with a postnatal age of 24-72 hours,
- •birth weight of 2500 g and above,
- •5th minute APGAR score above 6,
- •able to carry out vital activities without support,
- •fed within one hour before the procedure,
- •calm and not crying before the procedure,
- •babies who had heel prick for the first time
排除标准
- •with genetic or congenital anomaly,
- •with neurological, cardiological and metabolic diseases,
- •in need of respiratory support,
- •having a history of sedative, analgesic, or narcotic use within 24 h before admission,
- •hospitalization and surgical procedure experience in neonatal intensive care unit,
- •experience with needle interventions other than vitamin K and Hepatitis B vaccine,
- •babies of mothers with a history of substance abuse
结局指标
主要结局
Procedural pain score- Neonatal Infant Pain Scale (NIPS)
时间窗: 1 min before the heel lance procedure (T-1 min), during the procedure (T+0 sec), 2 min (T+2 min) and 5 min (T+5 min) after the procedure; an average of 6 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(Through painful procedure completion, an average of 5 minutes)
- Procedure time(Through painful procedure completion, an average of 2 minutes)
研究者
Aynur Aytekin Ozdemir
Professor
Istanbul Medeniyet University