Health TrialsbyHealthPanel

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

ConditionsEpilepsyPregnancy Related
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

at least 18 years of age

currently pregnant and primiparous

able to provide informed consent

able to have internet access

Disqualifiers

need of a language interpreter to provide informed consent and/or communicate with the MH-RTH musician

prior involvement in the Lullaby Project

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Lullaby ProjectActive comparator 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months
3

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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