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

University Health Network, Toronto

Status: Enrolling

Conditions: Epilepsy; Pregnancy Related

Treatments: Behavioral: Lullaby Project

Study type: Interventional

Funder types: Other

Identifiers

NCT05503290

21-6199

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Control

No Intervention group

Lullaby Project

Active Comparator group

Description:

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.

Treatment:

Behavioral: Lullaby Project