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NCT Number: NCT05503290

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.

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Key information

Conditions

Epilepsy Behavior Brain Diseases Central Nervous System Diseases Empowerment Nervous System Diseases Pregnancy Related Social Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location status: Recruiting

Location contact

Esther Bui, MD

CONTACT

[email protected]

416-603-5320

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lullaby Project

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esther Bui, MD

CONTACT

[email protected]

416-603-5320

Sharon Ng, BA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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