Effects of Non-Pharmacological Auditory Interventions on Pain and Anxiety in Pediatric Patients: A Randomized Controlled Trial Comparing White and Pink Noise
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- pain intensity
研究概览
简要总结
This study is a prospective, three-arm, single-blind, randomized controlled clinical trial designed to evaluate the effectiveness of non-pharmacological sound-based interventions on pain and anxiety in pediatric patients. The study will be conducted at a university hospital with 150 children aged 6-12 years who require peripheral intravenous (IV) catheterization. Participants will be randomly assigned to three groups: a white noise group, a pink noise group, or a control group (standard care). Sound interventions (white or pink noise at 50-55 dB) will be administered via noise-canceling headphones for 5 minutes before and during the IV procedure. The primary outcomes will be pain levels assessed by the Visual Analog Scale (VAS) and the Wong-Baker FACES Pain Rating Scale, and anxiety levels assessed by the Children's Fear and Anxiety Scale (CFAS). The study aims to provide evidence-based, safe, and cost-effective alternatives to pharmacological pain management in pediatric clinical procedures.
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 (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
- •Children between 7-12 years of age.
- •Scheduled for a peripheral intravenous (IV) catheterization procedure.
- •No know hearing impairment.
- •Parents/legal guardians willing and able to provide written informed consent.
排除标准
- •History of chronic pain or neurological disorder.
- •Use of any analgesic or sedative medication within 24 hours prior to the procedure.
- •Requiring emergency intervention (emergency catheterization).
- •inability to communicate or understand the procedure.
结局指标
主要结局
pain intensity
时间窗: During the peripheral intravenous (IV) catheterization procedure.
Pain intensity will be measured using the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale, ranging from 0 to 10, where higher scores indicate greater pain intensity.
次要结局
- Anxiety level(During the peripheral intravenous (IV) catheterization procedure.)
研究者
Zehra Özsoy Butay
Principal Investigator
Tokat Gaziosmanpasa University
