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

Not Applicable

Recruiting

• Conditions: Epilepsy; Pregnancy Related
• Interventions: Behavioral: Lullaby Project

• Registration Number: NCT05503290
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-13
• Study First Submitted QC: 2022-08-13
• Study First Posted: 2022-08-16
• Study Start: 2023-01-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lullaby Project	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.

Primary Outcome Measures

Name	Time	Method
Quality of Life in Epilepsy	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 Outcome Measures

Name	Time	Method
Depression and Anxiety	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	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.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada