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

NCT ID: NCT05503290

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized-controlled pilot study where enrolled subjects (primiparous individuals with epilepsy) will be randomized 1:1 to the control or intervention group (participation in the Lullaby Project). Outcomes of interest will be measured in each participant at day of consent, 3 weeks after, 7 weeks after, and 10 weeks after. A follow-up via email will be conducted for intervention participants 6 months after their last workshop.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Lullaby Project

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.

Group Type ACTIVE_COMPARATOR

Lullaby Project

Intervention Type BEHAVIORAL

Our proposed intervention is the randomized participation of pregnant individuals with epilepsy in the Lullaby Project coordinated by a musical institution in Toronto. The Lullaby Project is an initiative first created by Carnegie Hall's Weill Music Institute. In this program, pregnant women and/or new mothers are paired with professional musicians to compose and write personal lullabies for their child(ren). Since its inception in 2011, the project has expanded globally and have helped numerous families write original lullabies for their newborns. The Lullaby intervention is unlike traditional music therapy as patients are actively participating in the creative song-writing process, not singularly in passive listening. Through sessions, participants will be given an opportunity to share experiences, experiment with musical arrangements, write lyrics, and receive positive feedback from the musician.

Interventions

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Lullaby Project

Our proposed intervention is the randomized participation of pregnant individuals with epilepsy in the Lullaby Project coordinated by a musical institution in Toronto. The Lullaby Project is an initiative first created by Carnegie Hall's Weill Music Institute. In this program, pregnant women and/or new mothers are paired with professional musicians to compose and write personal lullabies for their child(ren). Since its inception in 2011, the project has expanded globally and have helped numerous families write original lullabies for their newborns. The Lullaby intervention is unlike traditional music therapy as patients are actively participating in the creative song-writing process, not singularly in passive listening. Through sessions, participants will be given an opportunity to share experiences, experiment with musical arrangements, write lyrics, and receive positive feedback from the musician.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age
* currently pregnant and primiparous
* able to provide informed consent
* able to have internet access
* have a confirmed diagnosis of epilepsy based on EEG or clinical evidence

Exclusion Criteria

* need of a language interpreter to provide informed consent and/or communicate with the MH-RTH musician
* prior involvement in the Lullaby Project
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Esther Bui

Assistant Professor, MD FRCPC

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Esther Bui, MD

Role: CONTACT

416-603-5320

Sharon Ng, BA

Role: CONTACT

Facility Contacts

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Esther Bui, MD

Role: primary

416-603-5320

Other Identifiers

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21-6199

Identifier Type: -

Identifier Source: org_study_id

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