Flamenco Music Therapy in Pregnant

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

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Therapy; Music
• Intervention / Treatment: Other: Music Therapy

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cádiz, Spain, E-11004
    • Alfonso Vargas-Macías

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: Experimental; To listen flamenco music during 30 minuts per day, during 2 weks	Other: Music Therapy; to listen flamenco music during 30 minuts per day during 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Telethusa Centre for Flamenco Research
• Investigators: Principal Investigator: Alfonso Vargas-Macías, PhD, Telesthusa Centre for Flamenco Research

Publications and helpful links

Helpful Links

• Website of the Research Project

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 19, 2019
• Study Completion (Anticipated): January 25, 2020

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 9, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Anxiety; Pregnant; Depression.; Flamenco music
• Other Study ID Numbers: TelethusaFlamenco

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No