Epilepsy, Pregnancy Related
Conditions
Keywords
Music, Empowerment
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.
Interventions
BEHAVIORALLullaby 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.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Feasibility and Acceptability | 12 months | 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. |
Countries
Canada
Contacts
CONTACTEsther Bui, MD
CONTACTSharon Ng, BA
Outcome results
None listed