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临床试验/NCT04830111
NCT04830111已完成不适用

The Effect of Heart Rate Variability Biofeedback Training on the Physical and Mental Health of Intrapartum Women

National Taipei University of Nursing and Health Sciences1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2020年8月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
Anxiety variable

研究概览

简要总结

In this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women.

详细描述

In this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women. The following validated self-report measures were administered before and at five days after the intervention, Perceived stress scale-10, Beck Anxiety Inventory, and Edinburgh Postnatal Depression Scale.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •aged 20 years or more
  • •able to understand and write Chinese
  • •singleton birth
  • •having a full-term and healthy newborn

排除标准

  • •suicidal ideations
  • •psychosis
  • •medical or obstetric complications

研究组 & 干预措施

heart rate variability biofeedback training group

Experimental

The goal of heart rate variability biofeedback is to increase heart rate variability through paced breathing exercises, which have shown to be effective in reducing stress and anxiety in general adult populations.

干预措施: heart rate variability biofeedback Application (Eureka iDestressor) (Device)

Care as usual

No Intervention

In this condition, all of this group take care by hospital routine and the questionnaires were completed over a period with similar intervals.

结局指标

主要结局

Anxiety variable

时间窗: baseline on childbirth first day (before the intervention).

The Beck Anxiety Inventory using 21 items on the scale describes a symptom of anxiety. Responses are rated from 0 (never) to 3 (very often), with higher scores corresponding to higher perceived anxiety.

Stress variable

时间窗: baseline on childbirth first day (before the intervention) .

The Perceived Stress Scale using 10 items to determine the self-perceived levels of unpredictability, lack of control, and burden during the last month of pregnancy. Responses are rated from 0 (never) to 4 (very often), with higher scores corresponding to higher perceived stress.

Depression variable

时间窗: baseline on childbirth first day (before the intervention).

The Edinburgh Postnatal Depression Scale was using 10 items to provide a valuable and efficient way to identify patients at risk of perinatal depression. Each item is scored from 0 to 3, with item scores summed to produce a total The Edinburgh Postnatal Depression Scale was using 10 items to provides a valuable and efficient way to identify patients at risk of perinatal depression. Each item is scored from 0 to 3, with higher scores corresponding to higher depression.

次要结局

  • Stress variable(on childbirth fifth day (after the intervention))
  • Anxiety variable(on childbirth fifth day (after the intervention))
  • Depression variable(on childbirth fifth day (after the intervention))

研究者

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

Wan-Lin Pan

assistant professor

National Taipei University of Nursing and Health Sciences

研究点 (1)

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