PregnancyNCT04153695
Flamenco Music Therapy in Pregnant
A study testing Music Therapy in people with Pregnancy and Music, run by Telethusa Centre for Flamenco Research at 1 site in Spain.
Trial summary
The use of music as a therapy for the psychological and emotional improvement of pregnant women has been well studied. Our hypothesis is that flamenco music can also involve psycho-emotional improvements in pregnant women Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2019to 25 Jan 2020
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer
- Single pregnancy
- Uncomplicated pregnancy,
- Expectations of vaginal delivery without complications
- Gestational age between 18 and 33 weeks,
Who cannot join
- Visual disorders
- Hearing disorcers
- Mental or cognitive disorders
- Difficulties in pregnancy,
- Medical complications,
- Smoker during the gestation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Flamenco Musical Intervention in Pregnant Women
The use of music as a therapy for the psychological and emotional improvement of pregnant women has been well studied. Our hypothesis is that flamenco music can also involve psycho-emotional improvements in pregnant women
Read the detailed description
The objective of the study is to analyze the effects of a flamenco musical intervention on the stress and anxiety of pregnant women in five Management Units of the Sanitary District in Bahía de Cádiz-La Janda (Spain).
50 pregnant women will voluntarily participate in this study (25 in a control group and 25 in the experimental group) The psychological health assessment will be measured through the Perceived Stress Scale (PSS), the State-Trait Anxiety Inventory (S-STAI) and the Edinburgh Postnatal Depression Scale (EDPS) pre and post exposure.
- Being tested
- Music Therapy
- Keywords
- Pregnant, Anxiety, Depression., Flamenco music
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
to listen flamenco music during 30 minuts per day during 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | To listen flamenco music during 30 minuts per day, during 2 weks Receives: Other: Music Therapy |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
Perceived Stress Scale is used in order to measure anxiety in adults. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety". It consists of fourteen questions that refer to the feelings and thoughts of the person surveyed during the last month.
It consists of fourteen questions that refer to the feelings and thoughts of the person surveyed during the last month. The answer format of each question is a Likert scale with five possible options. The minimum value is 0 (never) and maximun is 4 (very often). Higher score means the worse outcome.
Measured: 4 months
State-Trait Anxiety Inventory
It is a psychological inventory based on a 4-point Likert scale (from 0 or "Almost Never" to 3 or "Almost Always") and it consists of 20 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety, so the worse outcome.
Measured: 4 months
Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale is a set of 10 screening questions that can indicate whether a parent has symptoms that are common in women with depression and anxiety during pregnancy and in the year following the birth of a child. This is not intended to provide a diagnosis - only trained health professionals should do this.
Each question has four items and is evaluated from 0 to 3, according to the increase in the severity of the symptom. Questions 3, 5, 6, 7, 8, 9, 10 rank in reverse order. The total score can range from 0 to 30, with 0 being the best result and 30 the worst.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Aug 2019
- Primary completion19 Dec 2019 (estimated)
- Study completion25 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telethusa Centre for Flamenco Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfonso Vargas-Macías, PhD, Principal investigator, Telesthusa Centre for Flamenco Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153695
- Sponsor's protocol ID
- TelethusaFlamenco
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Flamenco Musical Intervention in Pregnant Women
- ClinicalTrials.gov ID
- NCT04153695
- Acronym / sponsor ID
- TelethusaFlamenco
- Keywords
- Pregnant, Anxiety, Depression., Flamenco music
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Telethusa Centre for Flamenco ResearchUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 19 Dec 2019 (estimated)
- Study completion
- 25 Jan 2020 (estimated)
- First posted
- 6 Nov 2019 (actual)
- 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.
The use of music as a therapy for the psychological and emotional improvement of pregnant women has been well studied. Our hypothesis is that flamenco music can also involve psycho-emotional improvements in pregnant women
Detailed description
The objective of the study is to analyze the effects of a flamenco musical intervention on the stress and anxiety of pregnant women in five Management Units of the Sanitary District in Bahía de Cádiz-La Janda (Spain).
50 pregnant women will voluntarily participate in this study (25 in a control group and 25 in the experimental group) The psychological health assessment will be measured through the Perceived Stress Scale (PSS), the State-Trait Anxiety Inventory (S-STAI) and the Edinburgh Postnatal Depression Scale (EDPS) pre and post exposure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Music TherapyTo listen flamenco music during 30 minuts per day, during 2 weks |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteer
- Single pregnancy
- Uncomplicated pregnancy,
- Expectations of vaginal delivery without complications
- Gestational age between 18 and 33 weeks,
Key exclusion criteria (6 listed)
- Visual disorders
- Hearing disorcers
- Mental or cognitive disorders
- Difficulties in pregnancy,
- Medical complications,
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 |
|---|---|---|
| Music Therapyto listen flamenco music during 30 minuts per day during 2 weeks | Other | Experimental |
Primary outcome
Perceived Stress Scale
Time frame: 4 months
Perceived Stress Scale is used in order to measure anxiety in adults. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety". It consists of fourteen questions that refer to the feelings and thoughts of the person surveyed during the last month. It consists of fourteen questions that refer to the feelings and thoughts of the person surveyed during the last month. The answer format of each question is a Likert scale with five possible options. The minimum value is 0 (never) and maximun is 4 (very often). Higher score means the worse outcome.
State-Trait Anxiety Inventory
Time frame: 4 months
It is a psychological inventory based on a 4-point Likert scale (from 0 or "Almost Never" to 3 or "Almost Always") and it consists of 20 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety, so the worse outcome.
Edinburgh Postnatal Depression Scale
Time frame: 4 Months
The Edinburgh Postnatal Depression Scale is a set of 10 screening questions that can indicate whether a parent has symptoms that are common in women with depression and anxiety during pregnancy and in the year following the birth of a child. This is not intended to provide a diagnosis - only trained health professionals should do this. Each question has four items and is evaluated from 0 to 3, according to the increase in the severity of the symptom. Questions 3, 5, 6, 7, 8, 9, 10 rank in reverse order. The total score can range from 0 to 30, with 0 being the best result and 30 the worst.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Website of the Research ProjectLink provided by the sponsor.
- 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.
Alfonso Vargas-Macías, PhD principal investigator
Telesthusa Centre for Flamenco Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Pregnancy and Music, run by Telethusa Centre for Flamenco Research at 1 site in Spain.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Perceived Stress Scale (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2019.