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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quality of Life in Epilepsy

Secondary outcome measures

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,472 Previous Clinical Trials

484,974 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor actively accepting new participants?

"Clinicaltrials.gov confirms that recruitment for this clinical trial began on August 15th, 202 and the most recent update was posted three days later. Consequently, participants are still being sought."

Answered by AI

How many individuals have enrolled in this medical study?

"Affirmative, clinicaltrials.gov attests to this medical trial's ongoing recruitment efforts. It was first posted on August 15th 2022 and has undergone a recent update on the 18th of August. The study requires 30 subjects from one location to be enrolled in order for it to conclude successfully."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy

Esther Bui 2023. "The Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05503290.

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