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

Epilepsy Clinical Trial

Official title:

A Pilot Study for the Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503290
• Other study ID #: 21-6199
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2024
• Source: University Health Network, Toronto
• Contact: Esther Bui, MD
• Phone: 416-603-5320
• Email: Esther.Bui[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Pregnancy Related

Intervention

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 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.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life in Epilepsy	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.	6 months
Secondary	Depression and Anxiety	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.	6 months
Secondary	Pregnancy-related Empowerment	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.	6 months