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

N/ANot Yet RecruitingNCT07727109

Tokat Gaziosmanpasa University150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

150

Conditions

Pain (Visceral, Somatic, or Neuropathic)Anxiety Acute

white noiseBEHAVIORAL

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 noiseBEHAVIORAL

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

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: During the peripheral intravenous (IV) catheterization procedure.

Secondary Outcomes

Anxiety level

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.