The Effect of Sound-Based Interventions on Pain and Anxiety in Pediatric Patients (PED-SOUND-PAIN)

July 22, 2026 updated by: Zehra Özsoy Butay, Tokat Gaziosmanpasa University

Effects of Non-Pharmacological Auditory Interventions on Pain and Anxiety in Pediatric Patients: A Randomized Controlled Trial Comparing White and Pink Noise

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Tokat Province, Merkez, Turkey (Türkiye), 60100
        • Tokat Gaziosmanpaşa University Hospital
        • Contact:
          • Tokat Gaziosmanpaşa University Hospital dr. öğr üyesi birgül vural
          • Phone Number: 03562129500
          • Email: hastane@gop.edu.tr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: white noise group
Participants 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.
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.
Other Names:
  • sound-based intervention
Experimental: Pink Noise Group
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.
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.
No Intervention: Control Group
Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: During the peripheral intravenous (IV) catheterization procedure.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety level
Time Frame: During the peripheral intravenous (IV) catheterization procedure.
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.
During the peripheral intravenous (IV) catheterization procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

July 12, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOGU-PED-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available starting 6 months after the study completion date and will remain available for 5 years.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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