Musical intervention for pregnant individuals with epilepsy
A Pilot Study for the Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy
This study tests if participating in a musical program can help pregnant individuals with epilepsy feel less stressed and more empowered during their pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05503290 on ClinicalTrials.gov |
What this trial studies
This intervention involves the randomized participation of pregnant individuals diagnosed with epilepsy in the Lullaby Project, which is coordinated by a musical institution in Toronto. The study aims to explore the potential benefits of this musical intervention on various aspects of quality of life, including symptoms of depression and anxiety, perceived stress, and feelings of empowerment. Participants will engage in musical activities designed to enhance their emotional well-being during pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals who are at least 18 years old, primiparous, and have a confirmed diagnosis of epilepsy.
Not a fit: Patients who require a language interpreter for informed consent or have previously participated in the Lullaby Project may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve the mental health and overall quality of life for pregnant individuals with epilepsy.
How similar studies have performed: While the specific approach of using music as an intervention for pregnant individuals with epilepsy is novel, similar studies have shown positive outcomes in using music therapy for mental health improvements.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Esther Bui, MD
- Email: Esther.Bui@uhn.ca
- Phone: 416-603-5320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.