Comparing The Effectiveness of Tracing Image and Coloring for Kids-Book With Two Passive Distractions on Pain and Fear in Children During Peripheral Intravenous Cannulation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain
研究概览
简要总结
Distraction is a non-pharmacological technique that moves focus away from anxiety, discomfort or unpleasant stimulation to more stimulating or friendly stimulation. Distraction is one of the most effective, simplest and inexpensive non-pharmacological pain management methods (Hockenberry & Wilson, 2018). The benefits of using non-pharmacological methods include decreased pain, distress, and fear reported by the parent, child, and/or observer (Wente, 2013). There are two main types of distraction techniques: active and passive (Mutlu & Balcı, 2015; Wohlheiter & Dahlquist, 2013).
Objectives:
To evaluate the roles of the TICK-B, listening music, and watching cartoon, in relieving pain and fear of school-age children during PIVC.
To compare the effect of TICK-B with the effects of the listening music, and watching cartoon, on reducing pain and fear during PIVC in children.
To compare the effects of three distraction groups with the control group in relieving pain and fear during PIVC.
详细描述
Peripheral intravenous cannulation (PIVC) is an invasive technique. In this technique, a catheter is entrenched through the skin of the recipient into the lumen of a peripheral blood vein. It is the second most painful procedure performed in hospitals. Peripheral intravenous cannulation (PICV) is a common painful procedure for children, and nearly all ill children have experience with PIVC, and up to 80% of patients receive a peripheral venous cannula in a hospital. Therefore, the use of effective methods in pain and anxiety relief is very important during injection procedures in children.
In order to relieve pain and fear in children undergoing PICV. Psychological and physical approaches for coping with children's pain are favored, as well as pharmacological methods. Application of topical anesthetic creams is the most commonly used pharmacological solution to reduce pain associated with the medical procedure, or refrigerant preparations, however, only reduce the perception of pain in children during procedures. These approaches are not resolved anxiety, a core factor of noncooperation, which encumbers the efficiency of the needle procedure. For this cause, non-pharmacological approaches are generally recognized as alternative techniques, which may be used separately or in addition to pharmacological approaches, to provide sufficient pain and fear relief and to offer children a sense of control over the situation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •School-aged 6-12 years old.
- •Children who require PIVC.
排除标准
- •Respiratory chronic diseases,
- •Physical impairment,
- •Disability contributing to difficult communication,
- •Children of unsatisfied parents,
- •Children with neurodevelopment delay,
- •Cognitive impairment, hearing impairment or a visual impairment,
- •Taking an analgesic within 6 hours, or for those with a syncope history.
结局指标
主要结局
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain
时间窗: 5 minutes before procedure done.
To assess the intensity of pain related to Peripheral intravenous cannulation procedure in children: Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
时间窗: 5 minutes before procedure done
To assess the fear level of the children related to Peripheral intravenous cannulation procedure: Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.
次要结局
- Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety(1-2 minute after cannulation procedure done.)
- Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain.(1-2 minutes after procedure done.)
研究者
Sherzad Khudeida Suleman
Principal Investigator (PhD Student)
University of Witten/Herdecke
