Pain (Visceral, Somatic, or Neuropathic)PED-SOUND-PAINNCT07727109
The Effect of Sound-Based Interventions on Pain and Anxiety in Pediatric Patients
A study testing white noise and pink noise in people with Pain (Visceral, Somatic, or Neuropathic) and Anxiety Acute, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pain (Visceral, Somatic, or Neuropathic), Anxiety Acute
- What is being tested?
- white noise and pink noise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Tokat Gaziosmanpaşa University Hospital
Tokat Province, Merkez, 60100
Tokat Gaziosmanpaşa University Hospital dr. öğr üyesi birgül vural, 03562129500, hastane@gop.edu.tr
About this study
Official title: Effects of Non-Pharmacological Auditory Interventions on Pain and Anxiety in Pediatric Patients: A Randomized Controlled Trial Comparing White and Pink Noise
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.
- Being tested
- white noise, pink noise
- Keywords
- pediatric pain, anxiety, white noise, pink noise, non-pharmacologiacal ıntervention
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
white noiseBehavioural
Also called 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 noiseBehavioural
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 group | Role | What they receive |
|---|---|---|
| white noise group | Experimental | 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. Receives: Behavioral: white noise |
| Pink Noise Group | Experimental | 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. Receives: Behavioral: pink noise |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the peripheral intravenous (IV) catheterization procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain (Visceral, Somatic, or Neuropathic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Özsoy Butay, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727109
- Sponsor's protocol ID
- TOGU-PED-2026
- Acronym
- PED-SOUND-PAIN
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available to researchers upon reasonable request, subject to institutional review board (IRB) approval and informed consent requirements.