A Pilot Study for the Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Quality of Life in Epilepsy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
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.
Intervention: Lullaby Project (Behavioral)
Outcomes
Primary Outcomes
Quality of Life in Epilepsy
Time Frame: 6 months
Assess quality of life related to epilepsy (via QOLIE-31-P, the Patient-Weighted Quality of Life in Epilepsy inventory); minimum value is 0 and maximum value is 100. Higher scores represent better quality of life.
Secondary Outcomes
- Depression and Anxiety(6 months)
- Pregnancy-related Empowerment(6 months)
- Feasibility and Acceptability(12 months)
Investigators
Esther Bui
Assistant Professor, MD FRCPC
University Health Network, Toronto