The Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy

April 29, 2026 updated by: Esther Bui, University Health Network, Toronto

A Pilot Study for the Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy

This study's proposed intervention is the randomized participation of pregnant individuals with epilepsy in the Lullaby Project coordinated by a musical institution in Toronto. The purpose of this present study is to investigate the potential benefits of the Lullaby Project on pregnant individuals with epilepsy. Namely, effects on quality of life-related to epilepsy, symptoms of depression and anxiety, perceived stress, and feelings of empowerment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • University Health Network
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Lullaby Project
Participants assigned to the intervention group will meet virtually with a professional musician for 5-7 sessions over the course of 10 weeks. Each session will last approximately 1.5 hours and will be conducted via Zoom.
Behavioral: Lullaby Project
Our proposed intervention is the randomized participation of pregnant individuals with epilepsy in the Lullaby Project coordinated by a musical institution in Toronto. The Lullaby Project is an initiative first created by Carnegie Hall's Weill Music Institute. In this program, pregnant women and/or new mothers are paired with professional musicians to compose and write personal lullabies for their child(ren). Since its inception in 2011, the project has expanded globally and have helped numerous families write original lullabies for their newborns. The Lullaby intervention is unlike traditional music therapy as patients are actively participating in the creative song-writing process, not singularly in passive listening. Through sessions, participants will be given an opportunity to share experiences, experiment with musical arrangements, write lyrics, and receive positive feedback from the musician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life in Epilepsy
Time Frame: 6 months
Assess quality of life related to epilepsy (via QOLIE-31-P, the Patient-Weighted Quality of Life in Epilepsy inventory); minimum value is 0 and maximum value is 100. Higher scores represent better quality of life.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression and Anxiety
Time Frame: 6 months
Assess symptoms of depression and anxiety (via DASS-21, the Depression, Anxiety and Stress Scale - 21 items). Depression scale scores range from 0 to 42 with higher scores representing greater depression severity. Anxiety scale scores range from 0 to 42 with higher scores representing greater anxiety severity. Stress scale scores range from 0 to 42 with higher scores representing greater stress.
6 months
Pregnancy-related Empowerment
Time Frame: 6 months
Assess feelings of empowerment related to pregnancy (via PRES, the Pregnancy-Related Empowerment Scale). Scores range from 16 to 64, with higher scores representing stronger feelings of pregnancy-related empowerment.
6 months
Feasibility and Acceptability
Time Frame: 12 months
Feasibility and acceptability will be assessed via semi-structured interviews with participants in the Lullaby project. Participants would be asked to share their experience of the intervention. Recordings would be transcribed and coded.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 13, 2022

First Submitted That Met QC Criteria

August 13, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-6199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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