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临床试验/NCT01457482
NCT01457482Unknown不适用

Art Therapy as Treatment for Fear of Childbirth:a Randomized Controlled Study

Helsingborgs Hospital2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2011年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
124
试验地点
2
主要终点
Scores for the Wijma Delivery Expectancy Questionnaire (W-DEQ)

研究概览

简要总结

Earlier research has shown that pregnant women with a pronounced fear of childbirth have a significantly increased risk for birth complications and subsequent psychological trauma. In Sweden and also internationally, women in fear of childbirth are treated in many differing ways. Evidence for best care for these women is lacking. The Art Therapy method is a creative, psycho-therapeutic form of treatment which has been used for several decades within psychiatry. It has recently been seen that the Art Therapy method has positive effects during treatment for crisis reactions.

Recruitment has recently been initiated for a randomized controlled study of Art Therapy for the treatment of fear of childbirth.

The hypothesis for the study is as follows:

H1 = treatment with Art Therapy and therapeutic conversations will result in a decrease in fear of childbirth when compared to treatment by therapeutic conversations only.

The instrument which is to be used for measurement of childbirth fear is the Wijma Delivery Expectancy Questionnaire (W-DEQ). This is a well validated instrument which was developed in Sweden. A power calculation has shown a need for 62 x 2 participants; a total of 124 women.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women
  • Pronounced fear of childbirth

排除标准

  • Women with a current psychiatric diagnosis
  • Women who do not understand Swedish
  • Women with a current substance misuse

结局指标

主要结局

Scores for the Wijma Delivery Expectancy Questionnaire (W-DEQ)

时间窗: Change in W-DEQ scores measured at entry to the study (approximately gestational weeks 20 to 31) and again at gestational week 36.

次要结局

未报告次要终点

研究者

发起方
Helsingborgs Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Helen Wahlbeck

Lic.Midwife, Art therapist

Helsingborgs Hospital

研究点 (2)

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