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NCT Number: NCT07727109

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

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpaşa University Hospital

Tokat Province, Merkez, 60100, Turkey (Türkiye)

Location contact

Tokat Gaziosmanpaşa University Hospital dr. öğr üyesi birgül vural

CONTACT

[email protected]

03562129500

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

White Noise

Behavioral

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

Pink Noise

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Birgül Vural

CONTACT

birgü[email protected]

+905308828480

Zehra Özsoy Butay

CONTACT

[email protected]

+905443259804

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Acronym: PED-SOUND-PAIN

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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