NCT04153695

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2020

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

November 4, 2019

Last Update Submit

November 9, 2019

Conditions

Keywords

PregnantAnxietyDepression.Flamenco music

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Experimental

EXPERIMENTAL

To listen flamenco music during 30 minuts per day, during 2 weks

Other: Music Therapy

Control

NO INTERVENTION

No intervention

Interventions

to listen flamenco music during 30 minuts per day during 2 weeks

Experimental

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteer
  • Single pregnancy
  • Uncomplicated pregnancy,
  • Expectations of vaginal delivery without complications
  • Gestational age between 18 and 33 weeks,

You may not qualify if:

  • Visual disorders
  • Hearing disorcers
  • Mental or cognitive disorders
  • Difficulties in pregnancy,
  • Medical complications,
  • Smoker during the gestation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfonso Vargas-Macías

Cadiz, E-11004, Spain

Location

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Alfonso Vargas-Macías, PhD

    Telesthusa Centre for Flamenco Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 6, 2019

Study Start

August 1, 2019

Primary Completion

December 19, 2019

Study Completion

January 25, 2020

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations