The Effect of Sound-Based Interventions on Pain and Anxiety in Pediatric Patients
PED-SOUND-PAIN
Effects of Non-Pharmacological Auditory Interventions on Pain and Anxiety in Pediatric Patients: A Randomized Controlled Trial Comparing White and Pink Noise
1 other identifier
interventional
150
1 country
1
Brief 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2026
CompletedFirst Posted
Study publicly available on registry
July 27, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
ExpectedJuly 27, 2026
July 1, 2026
Same day
July 12, 2026
July 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
During the peripheral intravenous (IV) catheterization procedure.
Secondary Outcomes (1)
Anxiety level
During the peripheral intravenous (IV) catheterization procedure.
Study Arms (3)
white noise group
EXPERIMENTALParticipants in this group will be exposed to white 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.
Pink Noise Group
EXPERIMENTALParticipants 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.
Control Group
NO INTERVENTIONParticipants in this group will receive standard care during the peripheral intravenous (IV) catheterization procedure. Headphones will be worn, but no sound intervention will be administered.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tokat Gaziosmanpaşa University Hospital
Tokat Province, Merkez, 60100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 12, 2026
First Posted
July 27, 2026
Study Start
September 1, 2026
Primary Completion
September 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
July 27, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be available starting 6 months after the study completion date and will remain available for 5 years.
- Access Criteria
- Researchers who provide a methodologically sound proposal may request access to the de-identified participant-level data. Proposals should be directed to the principal investigator. Access will be granted after institutional review board (IRB) approval and the signing of a data use agreement.
De-identified individual participant data will be made available to researchers upon reasonable request, subject to institutional review board (IRB) approval and informed consent requirements.