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Prenatal Listening to Songs Composed for Pregnancy and Symptoms of Anxiety and Depression: a Pilot Study

Primary Purpose

Prenatal Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Relaxation
Music
Sponsored by
Goldsmiths, University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prenatal Anxiety

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Relaxation Group

    Music Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).
    Edinburgh Postnatal Depression Scale
    Questionnaire measuring symptoms of maternal depression

    Secondary Outcome Measures

    Full Information

    First Posted
    May 12, 2016
    Last Updated
    May 2, 2017
    Sponsor
    Goldsmiths, University of London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02776293
    Brief Title
    Prenatal Listening to Songs Composed for Pregnancy and Symptoms of Anxiety and Depression: a Pilot Study
    Official Title
    Prenatal Listening to Songs Composed for Pregnancy and Symptoms of Anxiety and Depression: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Goldsmiths, University of London

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Prenatal anxiety and depression has negative implications for both the mother and the developing child, including developmental disorders, low birth weight, and altered immune function. It is therefore very important both to detect and to help ameliorate symptoms of anxiety and depression in pregnant women. Many women do not want pharmacological interventions at this time, and with less severe symptoms it may not be appropriate. Thus there is a need to find non-pharmacological methods of intervention. Psychological therapies such as cognitive behavioural therapy or interpersonal therapy can be effective. But these are often not available for the large numbers of women who could benefit. Though there has been evidence that music has the ability reduce anxiety, no study has quantitatively measured prenatal anxiety and depression over a long period of time. Proof of efficacy could justify investment into music as an inexpensive, and non-stigmatizing method to reduce prenatal anxiety and depression and therefore benefit both the mother and child.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prenatal Anxiety, Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    223 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Relaxation Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Music Group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Relaxation
    Intervention Type
    Behavioral
    Intervention Name(s)
    Music
    Primary Outcome Measure Information:
    Title
    State-Trait Anxiety Inventory
    Description
    Questionnaire measuring an individual's general level of anxiety (trait) and an individual's anxiety level at the time of taking the questionnaire (state).
    Time Frame
    12 weeks
    Title
    Edinburgh Postnatal Depression Scale
    Description
    Questionnaire measuring symptoms of maternal depression
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: English speaking women At least 18 years of age.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lauren Stewart, MSc. PhD.
    Organizational Affiliation
    Goldsmiths, University of London; Centre for Music in the Brain, Department of Clinical Medicine, Aarhus University & The Royal Academy of Music
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28482901
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Prenatal Listening to Songs Composed for Pregnancy and Symptoms of Anxiety and Depression: a Pilot Study

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