The Effects of Virtual Reality Glasses and External Cold and Vibration on Procedural Pain and Anxiety in Children During Venous Phlebotomy: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Wong-Baker FACES Pain Rating Scale
研究概览
简要总结
The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using external cold and vibration-Buzzy and VR on reducing procedural pain and anxiety in children aged 7 to 12 years during phlebotomy injection.
详细描述
In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. In light of this information, this study aimed to compare the effect of distraction by using Buzzy and VR on reducing procedural pain and anxiety in children aged 7 to 12 years during phlebotomy.
This study is a prospective, randomized and controlled trial. Children aged 7 to 12 years who required phlebotomy were divided into three groups; buzzy, virtual reality, and controls. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers and the children themselves who self-reported using Wong-Baker FACES. The children's anxiety levels were also assessed using the Children's Fear Scale.
The study population consisted of children aged 7 to 12 years who presented to the children's phlebotomy room of the hospital.
Sample of the study consisted of a total of 120 children who met the sample selection criteria and were selected via randomization method.
Children were randomized into three groups: Buzzy (n= 40), VR group (n= 40), and the control group (n= 40).
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
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The sample selection criteria of the study were as follows: the children who
- •were in the age group of 7-12 years,
- •Due to undergo phlebotomy for blood testing,
排除标准
- •had chronic diseases,
- •had neuro-developmentally delayed,
- •had visual, audio, or speech impairments,
- •were hospital stay for treatment,
- •had a history of sedative, analgesic or narcotic use within 24 hours before admission
结局指标
主要结局
Wong-Baker FACES Pain Rating Scale
时间窗: Through painful procedure completion, an average of 10 minutes
In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.
Children's Fear Scale
时间窗: Through painful procedure completion, an average of 10 minutes
CFS is used for measuring the child's anxiety level. CFS is a scale which makes an evaluation from 0 to 4 consisting of five facial expressions drawn to show expressions that vary from neutral expression (0=no anxiety) to scared face (4=severe anxiety).
次要结局
未报告次要终点
研究者
Diler Yilmaz
PhD, RN, Associate Professor
Bandırma Onyedi Eylül University