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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lullaby Project | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esther Bui, MD | Contact | 416-603-5320 | Esther.Bui@uhn.ca | |
| Sharon Ng, BA | Contact | Sharon.Ng@uhnresearch.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D000079102 | Empowerment |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012919 | Social Behavior |
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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.
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|
| 6 months |
| 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 |
| Feasibility and Acceptability | Feasibility and acceptability will be assessed via semi-structured interviews with participants in the Lullaby project. Participants would be asked to share their experience of the intervention. Recordings would be transcribed and coded. | 12 months |
| D001519 |
| Behavior |