Recruiting

Musical Intervention

Sponsor:

University Health Network, Toronto

Code:

NCT05503290

Conditions

Epilepsy

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lullaby Project

Study Details

Brief summary:

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.

Conditions

Epilepsy

Pregnancy Related

Study ID

NCT05503290

Start date

Jan 23, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Quality of Life in Epilepsy [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • Music
  • Empowerment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-06.