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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07727109

Acronym

PED-SOUND-PAIN

Enrollment

150

Registered

2026-07-27

Start date

2026-09-01

Completion date

2027-01-01

Last updated

2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Acute, Pain (Visceral, Somatic, or Neuropathic)

Keywords

pediatric pain, anxiety, white noise, pink noise, non-pharmacologiacal ıntervention

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.

Interventions

BEHAVIORALwhite 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.

BEHAVIORALpink 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
pain intensity	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

Measure	Time frame	Description
Anxiety level	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.

Countries

Turkey (Türkiye)

Contacts

CONTACTZehra Özsoy Butay

zehraozsy1@icloud.com+905443259804

CONTACTBirgül Vural

birgül.vural@gop.edu.tr+905308828480

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026