The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy® (Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
The aim of this study was to determine the effect of the distraction cards, virtual reality and Buzzy® methods on venipuncture pain and anxiety in children aged 7-12 years.
详细描述
The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) recommends pharmacological and nonpharmacological methods to effectively manage and prevent acute procedural pain in children. Nonpharmacological methods alone or in combination with pharmacological methods help reduce pain, and therefore, have become popular especially in recent years. For pain management, nonpharmacological methods are easy to use, and cost- and time-effective methods with no side effects. Studies have evaluated a large number of pharmacological and nonpharmacological interventions for procedural pain management in children. However, most of those interventions are not used by healthcare professionals because they are expensive, time-consuming or hard to use. Therefore, easy-to-use, practical, non-invasive, cost-effective, and reusable nonpharmacological methods, such as distraction cards, virtual reality and Buzzy®, can be used especially in acute settings.
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
- Single (Investigator)
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
- •Due to undergo venipuncture for blood testing
- •Suitable for venipuncture at antecubital location using a 21 Gauge X 1.5 inch needle
- •Due to undergo venipuncture under the same environmental conditions (phlebotomy seat, heat, light, noise, etc.)
- •Due to undergo venipuncture at the first attempt
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
Visual Analog Scale (VAS)
时间窗: Through painful procedure completion, an average of 10 minutes
The VAS is used to measure and monitor pain intensity. VAS is a 10 cm or 100 mm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end. The participant is asked to mark a point on the line that best represents their pain level. The VAS score is determined by measuring (in cm) the distance of the mark from the left end of the line. VAS is an easy-to-understand and easy-to-measure scale for children aged 7 and over.
Wong-Baker FACES Pain Rating Scale (WB-FACES)
时间窗: Through painful procedure completion, an average of 10 minutes
The WB-FACES was developed by Wong and Baker in 1981 and revised in 1983. 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 (0 = very happy/no pain, 5 = the worst pain imaginable). 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.
Children's Fear Scale (CFS)
时间窗: Through painful procedure completion, an average of 10 minutes
The CFS was developed by McMurtry et al. (2011) to measure fear and anxiety in children. It consists of five facial expressions that represent a range from neutral (0) to extreme fear (4). Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedures
次要结局
未报告次要终点
研究者
Aynur Aytekin Ozdemir
Associate Professor
Istanbul Medeniyet University