About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
white noise
BehavioralWhite 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
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
pain intensity
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.
Secondary outcomes
Anxiety level
Anxiety level will be measured using the Modified Yale Preoperative Anxiety Scale (m-YPAS), ranging from 23.33 to 100, where higher scores indicate greater anxiety levels.
Sponsors and contacts
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