ClinicalTrials.gg
Not yet recruitingNCT07727109PED-SOUND-PAINUpdated Jul 27, 2026

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

An interventional study of white noise and pink noise in Pain (Visceral, Somatic, or Neuropathic) and Anxiety Acute, sponsored by Tokat Gaziosmanpasa University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Tokat Gaziosmanpasa University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 20 studies in Pain by Tokat Gaziosmanpasa University — 4 open to participants now, 4 under way, none of them phase 3. Pain · Tokat Gaziosmanpasa University.

Planned enrollment
3rd of 16
150 · median 84
Started
2026
with 1 other
No phase
15 of 20
4 open now
Registered
19th of 20
by date

Among the 20 studies in Pain by Tokat Gaziosmanpasa University, this one is the 3rd largest by planned enrollment of the 16 interventional ones that give a count, is one of 2 that started in 2026, is one of 15 with no phase, and was the 19th registered.

Pain

10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.

Browse Pain studies →

Open to participants now

4 of the 20 studies in Pain by Tokat Gaziosmanpasa University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.

This study: 6 Years to 12 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 20 studies in Pain by Tokat Gaziosmanpasa University, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Pain (Visceral, Somatic, or Neuropathic)
  • Anxiety Acute

Keywords

  • pediatric pain
  • anxiety
  • white noise
  • pink noise
  • non-pharmacologiacal ıntervention
04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    white noise group

    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.

    Behavioral: white noise

  • Experimental
    Pink Noise Group

    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.

    Behavioral: pink noise

  • No intervention
    Control Group

    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.

Interventions

  • Behavioralwhite noise

    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.

    Also known as: sound-based intervention

  • Behavioralpink 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.

06

What researchers measure

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.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Data will be available starting 6 months after the study completion date and will remain available for 5 years.

Access criteria: Researchers who provide a methodologically sound proposal may request access to the de-identified participant-level data. Proposals should be directed to the principal investigator. Access will be granted after institutional review board (IRB) approval and the signing of a data use agreement.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2026, 0 months later.

Of 3,734 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 0 months is below that.

Counting every sponsor, half of 3,833 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2026
First posted
Jul 27, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 2026
CompletionEst.
Jan 1, 2027
Last update
Jul 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07727109
Responsible party
Zehra Özsoy Butay (Principal Investigator, Tokat Gaziosmanpasa University) — Principal investigator
First posted
Jul 27, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Jul 27, 2026

Study contacts

Zehra Özsoy Butay
Contact
zehraozsy1@icloud.com
+905443259804
Birgül Vural
Contact
birgül.vural@gop.edu.tr
+905308828480

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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