NCT03207919

Brief Summary

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. 1.To determine the potential effect of the Lullaby Project on maternal-fetal attachment.
  2. 2.To evaluate the potential impact of the Lullaby Project on maternal mental health.
  3. 3.To characterize the potential impact of the Lullaby Project on perceived maternal stress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 4, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

June 29, 2017

Last Update Submit

April 23, 2018

Conditions

Pregnancy Related

Keywords

maternal-fetal attachmentmaternal healthmaternal stressLullaby Project

Outcome Measures

Primary Outcomes (1)

  • Maternal Fetal Attachment

    As assessed by the Maternal Fetal Attachment Scale (MFAS)

    End of Study (2 months)

Secondary Outcomes (2)

  • Mental Health

    End of Study (2 months)

  • Perceived Maternal Stress

    End of Study (2 months)

Study Arms (2)

Lullaby Project

EXPERIMENTAL
Behavioral: Lullaby Project

Control Group

NO INTERVENTION

Interventions

Lullaby ProjectBEHAVIORAL

Pregnant women will participate in 3 group sessions. They will write and record a lullaby, and then listen to each recorded lullaby and reflect on their experience.

Lullaby Project

Eligibility Criteria

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

You may qualify if:

  • Age: at least 18 years of age.
  • Must be able to read and understand English, and provide informed consent.
  • Must be in the second or third trimester of pregnancy.

You may not qualify if:

  • Age: Under the age of 18.
  • Unable to read and understand English, and provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

  • Jennifer L Hinesley, Psy. D

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 5, 2017

Study Start

November 4, 2016

Primary Completion

May 15, 2017

Study Completion

May 15, 2017

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations

US(1)