The Effects of EMLA Cream and Cold Application on Pain, Fear and Vital Signs Before Chest Tube Removal in Children: 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
- 66
- 试验地点
- 1
- 主要终点
- Procedural pain score- Wong-Baker FACES Pain Rating Scale
研究概览
简要总结
This study is being conducted to determine the effect of EMLA cream and cold application on pain, fear and vital signs before chest tube removal in children aged 7-18 years.
详细描述
A chest tube is a device used to drain air or fluid from the pleural cavity under sterile conditions by inserting a thin or thick tube. Chest tubes adhere to the endothelium of the chest cavity after insertion and while in place. For this reason, the pulling force applied when they are removed breaks these adhesions and causes intense, localised and transient acute pain. Chest tube removal pain, defined as one of the patient's worst life experiences related to the surgical procedure, is an iatrogenic pain caused by an invasive procedure. Therefore, chest tube removal is a painful, anxious and frightening experience for the patient. There are few studies of pharmacological and non-pharmacological methods of pain control during chest tube removal in children. However, the management of pain associated with surgical procedures in childhood is very important for the management of pain, anxiety and fear that children will experience with future medical procedures.
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 3 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 and C 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 child is in just before the application (researcher blinding).
Research data will be entered into the computer database by coding the group name as A, B and C, and statistical analysis will be performed using this coding (statistician blinding).
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having two chest tubes (mediastinal/pleural) placed after open heart surgery
- •Turkish literate
- •With stable vital signs
- •Willing to participate in the research
排除标准
- •Experience with chest tube removal procedure
- •Using analgesics other than routine procedures before the procedure
- •Children receiving mechanical ventilation support
- •Children who have complications in the postoperative period (heart and respiratory failure, repeated surgery, etc.)
- •Children with a mental disability, perception problem, visual and hearing impairment
- •Children with communication problems. • Children with cold allergies
研究组 & 干预措施
EMLA cream
EMLA cream will be applied to the chest tube area 3 hours before the chest tube removal procedure. Then, the chest tube removal procedure will be performed.
干预措施: EMLA Cream (Drug)
Cold application
Before the chest tube removal procedure, an ice cube pack will be applied to the chest tube area. Cold application will continue until the skin temperature drops to 13.0 degrees. Then the chest tube removal procedure will be performed.
干预措施: Cold application (Procedure)
结局指标
主要结局
Procedural pain score- Wong-Baker FACES Pain Rating Scale
时间窗: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
The scale is used to diagnose pain in children aged 3-18 years. It consists of six facial expressions, each one representing an increasing degree of pain scored on a scale 0 to 5 from left to right. The first face is a happy face representing "no pain=0" while the last face is a crying face representing "the worst pain imaginable=5". Higher scores indicate low pain tolerance. Participants are asked to choose the facial expression that best represents their pain.
次要结局
- Oxygen saturation(3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure)
- Procedural fear score- Children's Fear Scale (CFS)(3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure)
- Pulse rate(3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure)
研究者
Aynur Aytekin Ozdemir
Professor
Istanbul Medeniyet University