Musical Intervention for Pregnant Women with Epilepsy

N/A

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at whether a program that involves singing lullabies to pregnant women with epilepsy can improve their quality of life, mental health, and stress levels.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves musical participation rather than medication or medical procedures, traditional physical side effects are not expected. However, participants may experience emotional responses related to engaging in creative expression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of Life in Epilepsy

Secondary study objectives

Depression and Anxiety

Pregnancy-related Empowerment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: ControlActive Control1 Intervention

Group II: Lullaby ProjectActive Control1 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.

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