NCT02776293

Brief Summary

Prenatal anxiety and depression are distressing for the expectant mother and can have adverse effects on her fetus and child. This study aimed to determine whether listening to specially composed songs would be an effective intervention for reducing symptoms of prenatal anxiety and depression over a period of 12 weeks.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

May 12, 2016

Last Update Submit

May 2, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • State-Trait Anxiety Inventory

    Questionnaire measuring an individual's general level of anxiety (trait) and an individual's anxiety level at the time of taking the questionnaire (state).

    12 weeks

  • Edinburgh Postnatal Depression Scale

    Questionnaire measuring symptoms of maternal depression

    12 weeks

Study Arms (2)

Relaxation Group

ACTIVE COMPARATOR

The relaxation group was asked to listen to their assigned audio file for at least 20 minutes a day and to record each time they had engaged in this activity. The audio file consisted of a two minute introduction. Following this, participants were instructed to sit undisturbed for 20 minutes.

Behavioral: Relaxation

Music Group

EXPERIMENTAL

The music group was asked to listen to their assigned audio file for at least 20 minutes a day and to record each time they had engaged in this activity. The audio file consisted of a two minute introduction. Following this, participants were instructed to listen to pre-recorded songs specifically composed for pregnancy.

Behavioral: Music

Interventions

RelaxationBEHAVIORAL
Relaxation Group
MusicBEHAVIORAL
Music Group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking women
  • At least 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nwebube C, Glover V, Stewart L. Prenatal listening to songs composed for pregnancy and symptoms of anxiety and depression: a pilot study. BMC Complement Altern Med. 2017 May 8;17(1):256. doi: 10.1186/s12906-017-1759-3.

MeSH Terms

Conditions

Depression

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lauren Stewart, MSc. PhD.

    Goldsmiths, University of London; Centre for Music in the Brain, Department of Clinical Medicine, Aarhus University & The Royal Academy of Music

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Lauren Stewart

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 18, 2016

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share