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临床试验/NCT04153695
NCT04153695Unknown不适用

Therapeutic Flamenco Musical Intervention in Pregnant Women

Telethusa Centre for Flamenco Research1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Perceived Stress Scale

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

Experimental

Experimental

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

干预措施: Music Therapy (Other)

Control

No Intervention

No intervention

结局指标

主要结局

Perceived Stress Scale

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Telethusa Centre for Flamenco Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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