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临床试验/NCT02972112
NCT02972112Unknown不适用

Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Pregnancy-Related Anxiety Questionnaire

研究概览

简要总结

Women in their 3rd trimester, represent a unique segment of the tokophobic population. In these cases help is needed within a very short and limited period of time. To date, no specific treatment targets this population in order to ameliorate the anxiety and to provide these women and their newborns with better obstetric and psychiatric outcomes. The present study investigates an accessible individual two session intervention conducted by midwives skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable stronger emotional regulation and increase of their capacity to accept unexpected changes during labor and feelings of control. The investigators expect this psychological adjustment to lead to a better course of delivery, less interventions including caesarian sections, and subjective birth experience.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Hebrew speaking pregnant women week 32 + 0 to 37 + 0
  • fulfilling the criteria for a specific phobia diagnosed by SCID (Structured Clinical Interview for the Diagnostic) in accordance with DSM-V (Diagnostic and Statistical Manual) and the Fear of Vaginal Delivery Questionnaire (FDQ).
  • Exclusion criteria:
  • Women who suffer from a psychotic disorder, PTSD or suicidal ideation
  • High risk pregnancies
  • Alcoholism or drug abuse and dependence.

排除标准

  • 未提供

结局指标

主要结局

Pregnancy-Related Anxiety Questionnaire

时间窗: In the end of second session of intervention- up to 4 weeks from screening

a widely used instrument to assess and identify pregnancy-specific anxiety in women

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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