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The Effect of Sound-Based Interventions on Pain and Anxiety in Pediatric Patients
Sponsor: Tokat Gaziosmanpasa University
Summary
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.
Official title: Effects of Non-Pharmacological Auditory Interventions on Pain and Anxiety in Pediatric Patients: A Randomized Controlled Trial Comparing White and Pink Noise
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-09-01
Completion Date
2027-01-01
Last Updated
2026-07-27
Healthy Volunteers
No
Interventions
white noise
White noise will be administered at a constant intensity of 50-55 dB using noise-canceling headphones for 5 minutes before and during the peripheral intravenous (IV) catheterization procedure.
pink noise
Participants in this group will be exposed to pink noise at a constant intensity of 50-55 dB via noise-canceling headphones for 5 minutes before and during the peripheral intravenous (IV) catheterization procedure.
Locations (1)
Tokat Gaziosmanpaşa University Hospital
Tokat Province, Merkez, Turkey (Türkiye)