30 Participants Needed

Musical Intervention for Pregnant Women with Epilepsy

EB
SN
Overseen BySharon Ng, BA
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Lullaby Project, a musical program, can improve life for pregnant women with epilepsy. Participants will collaborate with a professional musician over several virtual sessions to create lullabies, which may help with stress, depression, and empowerment. This trial suits pregnant women with epilepsy who can access the internet for virtual sessions. As an unphased trial, it offers a unique opportunity to explore creative ways to enhance well-being during pregnancy.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this musical intervention is safe for pregnant women with epilepsy?

Research shows that the Lullaby Project, a music program, is safe and well-received. In past studies, participants reported no negative effects or side effects. The project involves pregnant women with epilepsy working with musicians to create songs, indicating it is gentle and low-risk. While more research is needed to confirm its effectiveness, the safety record so far appears positive.12345

Why are researchers excited about this trial?

Researchers are excited about the Lullaby Project because it offers a novel, non-pharmacological approach to supporting pregnant women with epilepsy. Unlike traditional treatments that rely on antiepileptic drugs to manage seizures, this intervention uses music therapy to potentially reduce stress and improve mental well-being, which can be beneficial for both the mother and developing fetus. By engaging with a professional musician over several weeks, participants may experience a soothing effect that complements existing medical care, offering a holistic method to enhance overall health during pregnancy.

What evidence suggests that the Lullaby Project is effective for pregnant women with epilepsy?

Research suggests that the Lullaby Project, available to participants in this trial, might improve life for pregnant women with epilepsy. Some early studies show that this music-based approach can potentially reduce feelings of depression and anxiety. It might also lower stress levels and increase feelings of empowerment. Although more research is needed to confirm these benefits, the initial results are encouraging. Participants in the intervention group will meet with a musician, which may provide emotional and psychological support.12346

Are You a Good Fit for This Trial?

This trial is for pregnant individuals over 18 with a first-time pregnancy and diagnosed epilepsy, who can consent and access the internet. It's not for those needing an interpreter for consent or communication with musicians, or who've previously participated in the Lullaby Project.

Inclusion Criteria

I have been diagnosed with epilepsy through tests or symptoms.
Able to have internet access
Able to provide informed consent
See 1 more

Exclusion Criteria

I need an interpreter to understand and give consent.
Prior involvement in the Lullaby Project

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group meet virtually with a professional musician for 5-7 sessions over 10 weeks

10 weeks
5-7 virtual sessions

Follow-up

Participants are monitored for quality of life, depression, anxiety, and empowerment for 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Lullaby Project
Trial Overview The study examines how joining the Lullaby Project affects pregnant women with epilepsy. Participants are randomly chosen to work with musicians from a Toronto institution on creating lullabies, exploring impacts on life quality, stress, empowerment, and mental health.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Lullaby ProjectActive Control1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Citations

The Lullaby Project as a Musical Intervention for Pregnant ...Study Overview​​ The purpose of this present study is to investigate the potential benefits of the Lullaby Project on pregnant individuals with epilepsy. Namely, ...
Musical Intervention Program May Improve Quality of Life ...The "Lullaby Project" may improve quality of life for pregnant women with epilepsy, though further research is needed due to limited statistical ...
a pilot study of the impact of a musical non-pharmacological ...Conclusions: Our preliminary analysis shows that a musical intervention program such as the “Lullaby Project” is feasible for PPWE with a trend ...
The Lullaby Project as a Musical Intervention for Pregnant ...The purpose of this present study is to investigate the potential benefits of the Lullaby Project on pregnant individuals with epilepsy. Namely ...
The Lullaby Project as a Musical Intervention for Pregnant ...The purpose of this present study is to investigate the potential benefits of the Lullaby Project on pregnant individuals with epilepsy. Namely, effects on ...
YCB S3E8 - The Lullaby Project: Music as MedicineThe Lullaby Project is a program where it connects women with epilepsy who are pregnant—in my case—with songwriters to write a song for our ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security