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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04153695
Other study ID # TelethusaFlamenco
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date January 25, 2020

Study information

Verified date November 2019
Source Telethusa Centre for Flamenco Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date January 25, 2020
Est. primary completion date December 19, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Volunteer

- Single pregnancy

- Uncomplicated pregnancy,

- Expectations of vaginal delivery without complications

- Gestational age between 18 and 33 weeks,

Exclusion Criteria:

- Visual disorders

- Hearing disorcers

- Mental or cognitive disorders

- Difficulties in pregnancy,

- Medical complications,

- Smoker during the gestation period

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Music Therapy
to listen flamenco music during 30 minuts per day during 2 weeks

Locations

Country Name City State
Spain Alfonso Vargas-Macías Cádiz

Sponsors (1)

Lead Sponsor Collaborator
Telethusa Centre for Flamenco Research

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
4 months
Primary 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. 4 months
Primary 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.
4 Months
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