The Effect of Pediatric Invasive Pictorial Shield (PIPS) and Distraction Card Use on Pain, Fear and Anxiety in Blood Collection Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Oucher Scale
研究概览
简要总结
This study was planned as a randomized controlled experimental study to minimize the pain, anxiety and fear of the child during venous blood sampling in order to avoid a painful experience in the future. The research will be conducted in the Pediatric Blood Collection Unit of Giresun Gynecology and Obstetrics Training and Research Hospital in children aged 6-10 years. The research data will be collected using the "Information Form on Descriptive Characteristics of the Child and Blood Collection Procedure, Child Anxiety Scale-Disposition (CAS-D), Oucher Scale, Child Fear Scale (CFS), Venham Pictorial Anxiety Scale (VRAAS)" and Nurse-Patient Cooperation and Parent Satisfaction Form (NPPS-EMF).
详细描述
Invasive procedures are the most common and important sources of pain, anxiety, stress and fear for children. Painful procedures also cause reluctance to medical procedures and distrust of nurses in both children and parents. Pain, anxiety and fear from needle procedures in childhood can persist into adulthood. It may cause negative emotional effects in the long term. Therefore, it is very important to reduce or eliminate pain during stressful and uncomfortable procedures in children. Nurses should also provide atraumatic care to children by minimizing pain. Eliminating pain and improving the quality of life of children should be one of the main goals of nursing care. The methods used in pain control in children are pharmacologic and nonpharmacologic methods. One of the non-pharmacologic methods, the technique of distraction, is the concentration of attention on a stimulus other than pain. Unlike what we have previously encountered in the literature, the Pediatric Invasive Pictorial Shield (PIPS) also aims to minimize the impact of the intervention by preventing the child from seeing the procedure being performed. Distraction cards are also known to be an effective method in children. This study was planned as a randomized controlled experimental study to minimize the pain, anxiety and fear of the child during venous blood sampling in order to avoid a painful experience in the future. The research will be conducted in the Pediatric Blood Collection Unit of Giresun Gynecology and Obstetrics Training and Research Hospital in children aged 6-10 years. The research data will be collected using the "Information Form on Descriptive Characteristics of the Child and Blood Collection Procedure, Child Anxiety Scale-Disposition (CAS-D), Oucher Scale, Child Fear Scale (CFS), Venham Pictorial Anxiety Scale (VRAAS)" and Nurse-Patient Cooperation and Parent Satisfaction Form (NPPS-EMF).
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, Care Provider, Outcomes Assessor)
盲法说明
After the children who met the inclusion criteria were assigned to the study groups by stratified block randomization, their written informed consent will be obtained through the informed consent form without informing their parents which group they are included in. Since the researcher will administer the PIPS and distraction cards to the children, blinding will not be possible. However, in order to prevent detection bias, the output measurements of the study will be made by the nurse working in the blood collection unit where the study will be conducted, who does not know who is in the experimental group and who is in the control group. In order to prevent bias in the evaluation of the data, the study groups will be coded in the database as A, B and C by someone other than the researcher, and the data be analyzed by a statistical expert independent of the research. It was aimed to prevent statistical and reporting bias by blinding in terms of output measurements, statistical analysis
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The child must be between 6-10 years old, and the child and parents must agree to participate in the study
- •Blood collection is done by the same nurse
- •Standard information is given to the child and family before blood collection - - The blood collection method to be used for the procedure (butterfly set
- •Children should have the perception level to evaluate the pain/fear/anxiety scale (successfully complete the scale tests)
- •The child does not have any auditory, mental or neurological disability that may affect the child's participation in the research
- •The child has no hearing, speech or visual impairment Blood collection from the antecubital region
- •Single attempt intervention.
排除标准
- •The child has any special needs (physical, sensory or mental)
- •The child is admitted to the hospital with a complaint of acute pain
- •Body temperature outside the range of 36.5-37.2°C153
- •Having a disease that can cause chronic pain The child has taken analgesics in the last 6 hours
- •The child has a health problem that may affect the level of pain (tissue trauma, burn, fracture, etc.).
结局指标
主要结局
Oucher Scale
时间窗: 1 minute before, during procedure and 1 minute after the blood collection procedure.
Oucher is a poster-like tool designed to help children self-report the intensity of their pain. The Oucher consists of two scales: a numerical scale from 0-10 for older children and a photographic scale with six pictures for younger children. The Oucher can be used to assess pain intensity whenever the child is awake and conscious. Oucher can be used in children aged 3-12 years.
Child Anxiety Scale-Dispositional (CAS-D)
时间窗: 1 minute before, during procedure and 1 minute after the blood collection procedure.
The CAS-D is shaped like a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. In this scale for children aged four to ten, children instructed to "Imagine that all your anxious or nervous feelings are at the bulb or bottom of the thermometer". "If you are a little worried or nervous, the emotions might go up a little on the thermometer. If you are very, very anxious or nervous, emotions all the way to the top. Put a line on the thermometer showing how anxious or nervous you are". To measure state anxiety (CAS-D), the child is asked to mark how they feel "right now". The score can vary between 0 and 10
Child Fear Scale (CFS)
时间窗: 1 minute before, during procedure and 1 minute after the blood collection procedure.
This scale is used to determine the child's level of fear. The child fear scale is a visual scale consisting of five facial expressions characterized as no reaction (0=no anxiety) and scared face (4=severe anxiety) and can be scored from 0 to 4. It is intended for children aged 5-10 years (Gerçeker et al., 2018)
Venham Pictorial Anxiety Scale (VRAQ)
时间窗: 1 minute before, during procedure and 1 minute after the blood collection procedure.
It was developed as a situational anxiety scale for children. It measures anxiety appropriate for children in stressful situations. The scale was developed by Venham et al. in 1979. The scale is used for children over 3 years of age. The scale consists of eight sections and each section two pictures. The pictures in each section are shown to the child in order. The picture with anxiety is given 1 point and the picture without anxiety is 0 point. The lowest score is 0 and the highest score is 8 points. In the scoring system from 0 to 8, as the number of points increases, the rate of anxiety increases
次要结局
- Nurse-Patient Collaboration and Parental Satisfaction Form (NPPC-EMF)(5 minute after the blood collection procedure.)
研究者
Dilek Kucuk Alemdar
Professor
T.C. ORDU ÜNİVERSİTESİ