NCT05503290

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

August 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

August 13, 2022

Last Update Submit

April 29, 2026

Conditions

EpilepsyPregnancy Related

Keywords

MusicEmpowerment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Depression and Anxiety

    6 months

  • Pregnancy-related Empowerment

    6 months

  • Feasibility and Acceptability

    12 months

Study Arms (2)

Control

NO INTERVENTION

Lullaby Project

ACTIVE COMPARATOR

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.

Behavioral: Lullaby Project

Interventions

Lullaby ProjectBEHAVIORAL

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.

Lullaby Project

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • need of a language interpreter to provide informed consent and/or communicate with the MH-RTH musician
  • prior involvement in the Lullaby Project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

EpilepsyEmpowerment

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesSocial BehaviorBehavior

Central Study Contacts

Esther Bui, MD

CONTACT

416-603-5320Esther.Bui@uhn.ca

Sharon Ng, BA

CONTACT

Sharon.Ng@uhnresearch.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a randomized-controlled pilot study where enrolled subjects (primiparous individuals with epilepsy) will be randomized 1:1 to the control or intervention group (participation in the Lullaby Project). Outcomes of interest will be measured in each participant at day of consent, 3 weeks after, 7 weeks after, and 10 weeks after. A follow-up via email will be conducted for intervention participants 6 months after their last workshop. Participants in the lullaby project are invited for semi-structured interviews.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, MD FRCPC

Study Record Dates

First Submitted

August 13, 2022

First Posted

August 16, 2022

Study Start

January 23, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)