Musical Intervention for Pregnant Women with Epilepsy

Overseen By Sharon Ng, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Language barrier, Prior involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

Exclusion Criteria

I need an interpreter to understand and give consent.

Prior involvement in the Lullaby Project

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Control Active Control 1 Intervention

Group II: Lullaby Project Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+