Prenatal AnxietyNCT02776293
Prenatal Listening to Songs Composed for Pregnancy and Symptoms of Anxiety and Depression: a Pilot Study
A study testing Relaxation and Music in people with Prenatal Anxiety and Depression, run by Goldsmiths, University of London.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Anxiety, Depression
- What is being tested?
- Relaxation and Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English speaking women
- At least 18 years of age.
Who cannot join
None listed.
About this study
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.
Read the 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.
- Conditions
- Prenatal Anxiety, Depression
- Being tested
- Relaxation, Music
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelaxationBehavioural
MusicBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Edinburgh Postnatal Depression Scale
Questionnaire measuring symptoms of maternal depression
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prenatal AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldsmiths, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Stewart, Goldsmiths, University of London
- Investigators
- Lauren Stewart, MSc. PhD., Principal investigator, Goldsmiths, University of London; Centre for Music in the Brain, Department of Clinical Medicine, Aarhus University & The Royal Academy of Music
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776293
- Sponsor's protocol ID
- LV-001
- Status last verified
- May 2017
- First submitted
- 12 May 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28482901
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Listening to Songs Composed for Pregnancy and Symptoms of Anxiety and Depression: a Pilot Study
- ClinicalTrials.gov ID
- NCT02776293
- Acronym / sponsor ID
- LV-001
- Conditions
- Prenatal Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Goldsmiths, University of LondonUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation Group | Active comparator | Behavioral: RelaxationThe 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. |
| Music Group | Experimental | Behavioral: MusicThe 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking women
- At least 18 years of age.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation | Behavioural | Relaxation Group |
| Music | Behavioural | Music Group |
Primary outcome
State-Trait Anxiety Inventory
Time frame: 12 weeks
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
Time frame: 12 weeks
Questionnaire measuring symptoms of maternal depression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Derived from this study: PubMed 28482901Nwebube 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Stewart, MSc. PhD. principal investigator
Goldsmiths, University of London; Centre for Music in the Brain, Department of Clinical Medicine, Aarhus University & The Royal Academy of Music
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation and Music in people with Prenatal Anxiety and Depression, run by Goldsmiths, University of London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02776293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.