An interventional study of Lullaby Project in Epilepsy and Pregnancy Related, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Supportive care
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.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Quality of Life in Epilepsy
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.
Time frame: 6 months
Depression and Anxiety
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.
Time frame: 6 months
Pregnancy-related Empowerment
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.
Time frame: 6 months
Feasibility and Acceptability
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.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Sep 2026, 44 months after the start.
Of 337 non-industry interventional studies with no phase under Epilepsy, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 77. This study's planned 44 months is close to that.
Counting every sponsor, half of 358 studies reached it within 42 months; a quarter within 19 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
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