Pregnancy Related Clinical Trial
Official title:
The Lullaby Project: A Musical Intervention for Pregnant Women
This study will evaluate the potential impact of a brief musical intervention, the Lullaby
Project, in a sample of pregnant women. The study aims are:
1. To determine the potential effect of the Lullaby Project on maternal-fetal attachment.
2. To evaluate the potential impact of the Lullaby Project on maternal mental health.
3. To characterize the potential impact of the Lullaby Project on perceived maternal
stress.
Music has the power to build a sense of community and belonging - a crucial process in a U.S.
that is steadily becoming more diverse. In America, there is no more pressing issue for
children's development than their families' access to basic needs: housing, food, safety and
health, as well as education. While music may seem a long way from living wages or
immigration reform, the arts, including music, have a substantial role to play in building
healthy families.
Over the last three years, musicians from Carnegie Hall's Weill Music Institute have
developed the Lullaby Project, in which mothers living in challenging circumstances have the
opportunity to write and record a song for their babies or very young children. As of spring
2015, more than 150 lullabies have been created in hospitals, correctional facilities,
shelters, programs for teen parents, and other settings where young families face challenges
every day. The purpose of this music-based intervention is to initiate or encourage and
support the bonding process, to support parents' aspirations to create the family they want
for their children, and to harness their creativity as a tool for imagining and building
future possibilities.
This study proposes an arts-based intervention to improve maternal-child attachment. Based on
theory from the arts and evidence from psychology and pediatrics, this intervention will test
the ability of music creation to stimulate maternal attitudes regarding parenting, scores for
attachment, and symptoms of anxiety, depression, and stress. In addition, the intervention
will focus on at-risk women and their families with a goal of providing a healthier start for
their children and preventing transition of these parents and children into the high-risk
group.
Patients who consent to participate will be randomly assigned in a 1:1 ratio to participate
in an intervention or control group. Each participant will be asked to complete a self-report
battery of questionnaires pertaining to their pregnancy, mental health, and perceived stress.
At the completion of the questionnaires, referral information for mental health support will
be provided to all participants.
Women randomized to the intervention will participate in the three group sessions described
below with approximately 8-10 other pregnant women at Virginia Commonwealth University.
i. Session 1: (5 hours) Participants collaborate with project musicians to compose an
original lullaby. Efforts will be made to have a 1:1 musician-participant ratio, however,
depending on group size, two participants may be paired with one musician.
ii. Session 2: (5 hours) Participants collaborate with project musicians to refine and record
their lullaby. The recorded lullaby will not be collecting as data, nor will it be stored as
such for this study. No other recordings will be made during the course of this study.
iii. Session 3: (2 hours) Participants listen to each recorded lullaby and are invited to
informally reflect on their experience, both individually with one research staff member
(study or project coordinator), and within the group.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05017974 -
Research on Improving Sleep During Pregnancy
|
N/A | |
Completed |
NCT03284515 -
Vaccination In Pregnancy Gene Signature: VIP Signature Study
|
||
Recruiting |
NCT05969795 -
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
|
Phase 1 | |
Recruiting |
NCT06051201 -
Innovation for Small-scale Experiments: ReceptIVFity Test
|
N/A | |
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Enrolling by invitation |
NCT04527926 -
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
|
N/A | |
Recruiting |
NCT04278651 -
Early Antenatal Support for Iron Deficiency Anemia
|
Phase 4 | |
Recruiting |
NCT04405700 -
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
|
||
Recruiting |
NCT06258902 -
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
|
||
Completed |
NCT05487196 -
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
|
Phase 2 | |
Completed |
NCT03750968 -
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
|
Phase 2 | |
Enrolling by invitation |
NCT06127277 -
Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care
|
N/A | |
Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
Recruiting |
NCT05899101 -
The Impact of Opioid and Cannabis Exposure on Fetal Growth
|
||
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Completed |
NCT04296396 -
Opioid Prescription After Cesarean Trial
|
Phase 3 | |
Not yet recruiting |
NCT06069856 -
Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
Not yet recruiting |
NCT06069869 -
Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
Not yet recruiting |
NCT06079918 -
Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
|
Phase 3 | |
Not yet recruiting |
NCT04960800 -
Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis
|
N/A |