Can music soothe premature babies during painful eye exams?

NCT ID NCT05967572

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests whether playing different types of music during retinopathy of prematurity (ROP) eye exams can reduce pain and improve comfort in premature infants. ROP exams are necessary but can be painful and stressful for babies. Researchers will compare pain and comfort scores in infants who listen to music versus those who do not, to see if music offers a simple, non-drug way to help.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Different types of music played during retinopathy examination
What this could lead to
If music helps, it could offer a simple, drug-free way to reduce pain and improve comfort for premature babies during eye exams.
What could go wrong
This is a small, early-stage trial, and results may not apply to all infants. Music might not significantly change pain or comfort levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

84 people

The number who actually took part.

Started

Jun 2023

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

28 to 36 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * • Gestational age ≤34 weeks * Birth Weight ≤2000 grams * Preterm newborns with a corrected/postnatal age of 28-36 weeks at the time of examination * Having the baby's first ROP examination * Not giving sedative, opioid and anticonvulsant drugs before/during the examination * Parents do not have diagnosed mental or mental problems and agree to participate in the research. Exclusion Criteria: * Presence of a condition that prevents pain assessment (intracranial hemorrhage, neuromotor developmental retardation, etc.) * Oxygen requirement (nasal cannula, hood or incubator) * Having any congenital defect (eye, neurological) that may adversely affect the examination * Having a diagnosed hearing loss * Performing a different painful procedure at least one hour before the ROP * Being connected to a mechanical ventilator * Congenital hearing problems in family members

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Conditions

The condition(s) this trial relates to.

Pain Premature Birth retinopathy of prematurity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Necmettin Erbakan University

    Konya, Meram, Turkey (Türkiye)

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