Clinical Trial

The Effect of Sound-Based Interventions on Pain and Anxiety in Pediatric Patients

Study acronym: PED-SOUND-PAIN
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07727109
Lead Sponsor Tokat Gaziosmanpasa University
Conditions Pain (Visceral, Somatic, or Neuropathic), Anxiety Acute
Enrollment 150 participants
Start Date 2026-09-01
Primary Completion 2026-09 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-27