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A Mother's lullaby may be as powerful as medicine for Post-Surgery pain in toddlers

NCT ID NCT07785297

Symptom relief Sponsor: Kocaeli University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether hearing a mother's recorded lullaby can reduce pain and improve comfort in children aged 1 to 3 years after minor surgery. Half the children will listen to the lullaby, while the other half hears white noise, for one hour after waking up. Researchers will measure pain, comfort, and vital signs to see if a familiar voice offers a natural way to ease recovery.

What this could mean

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

Active substance
Maternal voice recording (lullaby) or white noise recording, played for 60 minutes after surgery
What this could lead to
If effective, this could offer a simple, drug-free way to reduce pain and improve comfort in young children after surgery.
What could go wrong
This is a small, early-stage trial, and results may not apply to all children or surgeries. The effect may be modest, and individual responses can vary.

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

90 people

The number who actually took part.

Started

Jan 2024

Finished

Jan 2026

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

1 year to 3 years

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: * Aged 1 to 3 years * Scheduled to undergo an elective minor surgical procedure, such as orchiopexy, hypospadias repair, or hernia repair * Undergoing surgery under general anesthesia with an anesthesia duration not exceeding 60 minutes * No known hearing impairment * No anatomical abnormality of the ear * No chronic condition that could affect auditory perception or pain response, such as cerebral palsy, Down syndrome, or another neurodevelopmental disorder * Scheduled for direct transfer to the pediatric surgery ward after surgery without an extended stay in the postanesthesia care unit * Written informed consent provided by a parent or legal guardian Exclusion Criteria: * Surgery performed under emergency conditions * A surgical procedure different from the planned procedure * Anesthesia duration exceeding 60 minutes * Development of a postoperative complication requiring admission to the postanesthesia care unit or intensive care unit * Administration of additional analgesic medication beyond the institutional analgesia protocol * Interruption or inability to complete the 60-minute auditory intervention or observation period * Withdrawal of consent by the parent or legal guardian

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Conditions

The condition(s) this trial relates to.

agnosia Pain, Postoperative

As listed by the trial registrant

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

Children Comfort Physiological parameters Postoperative pain

Contacts and locations

Locations

  • Kocaeli University

    Kocaeli, İ̇zmi̇t, Turkey (Türkiye)

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