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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02776293
Other study ID # LV-001
Secondary ID
Status Completed
Phase N/A
First received May 12, 2016
Last updated May 2, 2017
Start date January 2014
Est. completion date July 2015

Study information

Verified date May 2017
Source Goldsmiths, University of London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 223
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- English speaking women

- At least 18 years of age.

Study Design


Intervention

Behavioral:
Relaxation

Music


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Goldsmiths, University of London

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Edinburgh Postnatal Depression Scale Questionnaire measuring symptoms of maternal depression 12 weeks
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