Evaluation of the Effect of the Integrated Innovative Bed Apparatus Developed for the Relief of Pain and Anxiety in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain Score Change
研究概览
简要总结
Pain and anxiety are common responses in pediatric patients undergoing invasive procedures and can negatively affect both immediate care outcomes and future health-care experiences. Non-pharmacological interventions, especially those involving multisensory distraction, are increasingly used to alleviate distress. This study aimed to evaluate the effectiveness of a novel, child-friendly, multisensory support device in reducing pain and anxiety in pediatric surgical patients.
Keywords: child, pain, anxiety, distraction, pediatrics, innovative device
详细描述
This randomized controlled trial included 48 children aged 4-12 years who were hospitalized in the pediatric surgery unit of a tertiary hospital in Istanbul, Turkey, and who underwent an invasive procedure for the first time. Participants were randomly assigned to either the intervention (n=24) or control group (n=24) using block randomization based on age and sex. The intervention group received a Multisensory Pediatric Support Device that delivered combined audio (storybook narration), visual (lights), and animated stimuli during the procedure. The control group received standard preoperative and postoperative care. Pain and anxiety were measured using the Wong-Baker FACES Pain Rating Scale and the Children's Anxiety Meter State (CAM-S), respectively.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 12 years.
- •Hospitalized in the pediatric surgery ward.
- •Undergoing an invasive intervention (e.g., intravenous catheter insertion, intramuscular injection, wound care) for the first time during their hospital stay.
- •Able to communicate and understand simple instructions.
- •Written informed consent obtained from legal guardians and verbal assent from the child (as appropriate to developmental level).
排除标准
- •Children with cognitive impairments or developmental delays that prevent communication or reliable self-reporting.
- •Children with previous experience of invasive procedures during the current hospitalization.
- •Children receiving sedation or pharmacological anxiolytics before the procedure.
- •Children or legal guardians who refuse to provide informed consent.
研究组 & 干预措施
MSPSD Intervention Group
Participants received multisensory pediatric support device (MSPSD) during invasive procedures.
干预措施: Multisensory Pediatric Support Device (MSPSD) (Device)
Standard Care Group
Participants received standard care without any multisensory device.
结局指标
主要结局
Pain Score Change
时间窗: Before and immediately after invasive procedure.
Assessed by Wong-Baker FACES Pain Rating Scale (min: 0, max: 10)
Anxiety Score Change
时间窗: Before and immediately after invasive procedure.
Assessed by Children's Anxiety Meter State (CAM-S) (min: 0, max: 30)
次要结局
未报告次要终点
研究者
Evin Korkmaz
assist. prof.
Bahçeşehir University