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

NCT07727109 — Not applicable, Not yet recruiting, 150 participants, Tokat Gaziosmanpasa University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07727109, acronym PED-SOUND-PAIN
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, supportive care
Enrollment	150 (Estimated)
Sponsor	Tokat Gaziosmanpasa University (Other)
Conditions	Pain (Visceral, Somatic, or Neuropathic), Anxiety Acute
Interventions	white noise, pink noise (Behavioral)
Dates	start 2026-09-01 (estimated), primary completion 2026-09-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-07-27, last updated 2026-07-27
Locations	1 site in Turkey (Türkiye)

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
white noise group	Experimental	Behavioral: white noise	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.
Pink Noise Group	Experimental	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.
Control Group	No intervention		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.

white noise (Behavioral), also known as sound-based intervention: 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.
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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 6 Years to 12 Years

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.

+Locations (1)

Facility	City	Country	Status
Tokat Gaziosmanpaşa University Hospital	Tokat Province, Merkez	Turkey (Türkiye)