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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorTokat Gaziosmanpasa University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: white noise groupExperimental treatment 1 intervention
Group B: Pink Noise GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

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.

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

Other outcomes

Sponsors and contacts

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