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Behavioral Intervention

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

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 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

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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
500,175 Total Patients Enrolled

Media Library

Lullaby Project (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05503290 — N/A
Pregnancy Research Study Groups: Control, Lullaby Project
Pregnancy Clinical Trial 2023: Lullaby Project Highlights & Side Effects. Trial Name: NCT05503290 — N/A
Lullaby Project (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05503290 — N/A
~4 spots leftby Jan 2025
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