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A Mother's voice as medicine? trial tests comforting effect on ventilated children

NCT ID NCT07753486

Symptom relief Sponsor: TC Erciyes 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tests whether playing a recording of a mother's voice can help reduce pain and the need for sedation in young children (ages 1-3) who are on mechanical ventilators in the intensive care unit. Half the children will listen to a 10-minute recording of their own mother reading a storybook through headphones, while the other half receives standard care. Researchers will measure pain, comfort, heart rate, oxygen levels, and blood pressure before, during, and after the session to see if the maternal voice makes a difference.

What this could mean

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

Active substance
Recorded maternal voice (a 10-minute audio recording of the child's mother reading a storybook, played through headphones)
What this could lead to
If effective, this simple, drug-free intervention could offer a comforting way to reduce pain and sedation needs in critically ill children on ventilators, potentially improving their comfort and recovery.
What could go wrong
This is a small, early-stage trial with only 28 children, so results may not apply broadly. The effect might be limited or not significant, and the intervention's success depends on individual responses.

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

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

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: * Children aged 1-3 years, intubated and mechanically ventilated under sedation * No change in sedation dose within the last 24 hours * No hearing impairment in the child * Parent has no visual, hearing, or speech impairment * Parent is a Turkish speaker/reader with at least a primary school education * Parent provides written and verbal informed consent Exclusion Criteria: * Children receiving care/treatment due to surgical operation or trauma * Children who experience cardiac arrest during the study * Children whose parent withdraws consent during the study * Children who are extubated during the study

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

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

Mechanical ventilation Pain Sedation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kayseri City Hospital

    Kayseri, Kayseri, Turkey (Türkiye)

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