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临床试验/NCT01141010
NCT01141010已完成不适用

Effect of Perioperative Psychological Interventions on Maternal Outcomes Undergoing Cesarean Delivery

Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 365 人开始时间: 2010年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
365
试验地点
1
主要终点
Self anxiety assessment scale (SAS)

研究概览

简要总结

Pregnancy induced psychosis is an essential factor that influencing maternal health postpartum. When gravidas, especially nulliparas, facing labor and delivery, they will undoubtedly encounter burden from their own and surrounding facts. Maternal psychosis takes a large part of women's psychological disorders. No matter which way, either spontaneous or surgical, they would choose, many factors influence their psychological state. Cesarean section poses higher risks for women than vaginal delivery. Therefore, how to seek effective methods to alleviate parturients' psychological stress response possesses pivotal clinical implications. Herein the investigators proposed that different linguistic interventions given pre-, intra- or post-operatively would produce different effect on maternal psychology and internal stress level.

研究设计

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

入排标准

年龄范围
19 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Chinese gravidas
  • Gestational age >=36 wk
  • Nulliparas
  • Undergoing selective Cesarean section

排除标准

  • With recognition problem
  • Used or using centrally acting drugs
  • With chronic pain
  • Refusal participation
  • With existed psychiatric disorders
  • With history of psychological diseases
  • Contraindications for neuraxial anesthesia

结局指标

主要结局

Self anxiety assessment scale (SAS)

时间窗: One day prior surgery

Scorings of SAS evaluation by the patient herself

次要结局

  • Self depression assessment scale (SDS)(One day prior surgery)
  • Visual analog scale of pain (VAS pain)(Five min before surgery (-5 min))
  • Saliva cortisol level(30 min postoperation)
  • Vital signs(30 min postoperation)
  • SAS scorings(30 min postoperation)
  • SDS scoring(30 min postoperation)
  • VAS pain scoring(3 h after surgery)

研究者

发起方
Nanjing Medical University
申办方类型
Other

研究点 (1)

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