Tokat Gaziosmanpaşa University Hospital
Tokat Province, Merkez, 60100, Turkey (Türkiye)
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Tokat Gaziosmanpaşa University Hospital dr. öğr üyesi birgül vural
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NCT Number: NCT07727109
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.
Trial opening soon.
Get Notified6 year–12 year
All sexes
Interventional
Not applicable
Tokat Province, Merkez, 60100, Turkey (Türkiye)
Tokat Gaziosmanpaşa University Hospital dr. öğr üyesi birgül vural
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Tokat Gaziosmanpasa University
Other
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
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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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