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Lullabies for epilepsy: a musical stress relief for expectant moms

NCT ID NCT05503290

Symptom relief Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether participating in the Lullaby Project—where pregnant women with epilepsy work with musicians to create a personal lullaby—can improve their quality of life and reduce anxiety, depression, and stress. Thirty first-time pregnant women with epilepsy will be randomly assigned to the lullaby program or standard care. The goal is to see if this creative, non-drug approach offers emotional benefits during pregnancy.

What this could mean

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

Active substance
Lullaby Project (music composition program)
What this could lead to
If it works, this could offer a simple, non-drug way to ease stress and improve well-being during pregnancy for people with epilepsy.
What could go wrong
This is a very small pilot study (30 people) with no blinding, so results may not be generalizable. The main benefit is likely emotional support, not a medical treatment.

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 30 people

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

Started

Jan 2023

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

18 years and older

Sex

Female participants only

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: * at least 18 years of age * currently pregnant and primiparous * able to provide informed consent * able to have internet access * have a confirmed diagnosis of epilepsy based on EEG or clinical evidence Exclusion Criteria: * need of a language interpreter to provide informed consent and/or communicate with the MH-RTH musician * prior involvement in the Lullaby Project

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Conditions

The condition(s) this trial relates to.

Empowerment epilepsy pregnancy disorder

As listed by the trial registrant

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

Epilepsy Pregnancy related

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

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5T 2S8, Canada

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