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 The Corporation of Massey Hall and Roy Thomson Hall (MH-RTH) 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.

Full Title of Study: “A Pilot Study for the Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2023

Interventions

  • Behavioral: Lullaby Project
    • Our proposed intervention is the randomized participation of pregnant individuals with epilepsy in the Lullaby Project coordinated by The Corporation of Massey Hall and Roy Thomson Hall (MH-RTH) 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.

Arms, Groups and Cohorts

  • No Intervention: Control
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Depression and Anxiety
    • Time Frame: 6 months
    • Assess symptoms of depression and anxiety (via DASS-21, the Depression, Anxiety and Stress Scale – 21 items). Depression scale scores range from 0 to 42 with higher scores representing greater depression severity. Anxiety scale scores range from 0 to 42 with higher scores representing greater anxiety severity. Stress scale scores range from 0 to 42 with higher scores representing greater stress.
  • Pregnancy-related Empowerment
    • Time Frame: 6 months
    • Assess feelings of empowerment related to pregnancy (via PRES, the Pregnancy-Related Empowerment Scale). Scores range from 16 to 64, with higher scores representing stronger feelings of pregnancy-related empowerment.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Principal Investigator: Esther Bui, Assistant Professor, MD FRCPC – University Health Network, Toronto
  • Overall Contact(s)
    • Esther Bui, MD, 416-603-5320, Esther.Bui@uhn.ca

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