The Effect of Sound-Based Interventions on Pain and Anxiety in Pediatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: white noise, pink noise.
- Who it may be relevant to
- Registry conditions: Pain (Visceral, Somatic, or Neuropathic), Anxiety Acute. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Non-Pharmacological Auditory Interventions on Pain and Anxiety in Pediatric Patients: A Randomized Controlled Trial Comparing White and Pink Noise
Overview
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.
Interventions
- Behavioral 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. - Behavioral 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.
Primary outcome measures
- pain intensity [Time frame: During the peripheral intravenous (IV) catheterization procedure.]
Secondary outcome measures (1)
- Anxiety level [Time frame: During the peripheral intravenous (IV) catheterization procedure.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Tokat Gaziosmanpaşa University Hospital — Tokat Province
Identifiers
NCT: NCT07727109 · TOGU-PED-2026