The Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lullaby Project.
- Who it may be relevant to
- Registry conditions: Epilepsy, Pregnancy Related. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Study for the Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy
Overview
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.
Interventions
- Behavioral 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
Primary outcome measures
- Quality of Life in Epilepsy [Time frame: 6 months]
Secondary outcome measures (3)
- Depression and Anxiety [Time frame: 6 months]
- Pregnancy-related Empowerment [Time frame: 6 months]
- Feasibility and Acceptability [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- University Health Network — Toronto
Identifiers
NCT: NCT05503290 · 21-6199