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临床试验/NCT07727109
NCT07727109尚未招募不适用

Effects of Non-Pharmacological Auditory Interventions on Pain and Anxiety in Pediatric Patients: A Randomized Controlled Trial Comparing White and Pink Noise

Tokat Gaziosmanpasa University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年9月1日最近更新:
适应症

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

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

发起方
Tokat Gaziosmanpasa University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zehra Özsoy Butay

Principal Investigator

Tokat Gaziosmanpasa University

研究点 (1)

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