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临床试验/NCT05182541
NCT05182541招募中不适用

Psychological Screening and Nursing of Twin Pregnancy

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Self-rating Anxiety Scale (SAS)

研究概览

简要总结

Objectives This research will screen the psychological problems of twin pregnant women step by step and detect early and treat early in order to reduce the incidence of mental diseases and promote the health of mother and baby.

详细描述

Method Twin pregnant women recruited for the study.The two groups were given routine treatment and nursing measures. The trained group members were given routine psychological care to the control group, while the intervention group was given step-by-step psychological care at the same time.

Evaluate the effect

  1. Evaluation methods include process evaluation and result evaluation. Process assessment means that the researchers use the pregnancy stress scale, self rating depression scale and self rating anxiety scale to assess the stress, anxiety and depression of patients at different stages, and make intervention decisions according to the score results; Results evaluation means that if the intervention is effective at a certain stage, the researcher can use it again
  2. The evaluation indexes included PPS / SAS / SDS, incidence of preterm birth, premature rupture of membranes and blood pressure.

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
Single (Participant)

入排标准

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

入选标准

  • Clinical diagnosis of intrauterine twin pregnancy.
  • The patients whose psychological screening scale score reached the critical value (pregnancy stress scale >50 and/or Self rating depression scale ≥ 40 and/or The self rating Anxiety Scale (SAS) was more than
  • The outpatient department of the research hospital was established and antenatal examination was carried out regularly.
  • No mental and communication disorders (including depression and other mental diseases).
  • Voluntary participation in this study

排除标准

  • Pregnancy complicated with severe physical diseases;
  • Drop out of this study due to various reasons (including abortion, unwilling to participate in this study)

结局指标

主要结局

Self-rating Anxiety Scale (SAS)

时间窗: pregnancy 6-14 week

If scores are less than 50, it is defined as normal; If scores are 50-59, it is defined as mild anxiety; If scores are 60-69, it is defined as moderate anxiety; If scores are ≥70, it is defined as severe anxiety.

Pregnancy stress scale Self rating Anxiety Scale Depression self rating scale(PPS/SAS/SDS)

时间窗: pregnancy 6-14 week

If scores are less than 50, it is defined as normal; If scores are 50-59, it is defined as mild pregnancy stress; If scores are 60-69, it is defined as moderate pressure; If scores are ≥70, it is defined as severe pregnancy stress

Self-rating Depression Scale (SDS)

时间窗: pregnancy 6-14 week

If scores are less than 50, it is defined as normal; If scores are 50-59, it is defined as mild depression; If scores are 60-69, it is defined as moderate depression; If scores are ≥70, it is defined as severe depression

次要结局

  • Weight in kilogram of neonate(At birth of neonate)
  • Gestational age and prolongation of gestational age at delivery(28-37 weeks; after delivery 1 month)
  • Self-rating Anxiety Scale (SAS)(28-37 weeks; after delivery 1 month)
  • Self-rating Depression Scale (SDS)(28-37 weeks; after delivery 1 month)
  • Pregnancy stress scale(28-37 weeks; after delivery 1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Caixia Liu

Clinical Professor

Shengjing Hospital

研究点 (1)

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