Heart Rate Variability Biofeedback (HRVB) With Mothers Who Delivered a Preterm Infant: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Satisfaction Regarding the Intervention
研究概览
简要总结
Mothers who deliver prematurely (<37 weeks of gestational age) experience intense stress and anxiety given that their child's survival and development might be compromised. From the existing literature, it is known that a heart rate variability biofeedback (HRVB) program increases heart rate variability (HRV), which in turn, is related to significant reductions in perceived stress and anxiety. This study's aim is to evaluate the feasibility of an HRVB program in a sample of mothers who delivered prematurely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Delivery between 33 and 37 weeks of gestational age
- •Living in Lausanne or surroundings
- •Infant is expected to survive
- •Singleton birth
- •Consent of mother to participate in the study
- •Sufficient French-speaking skills to fill out the questionnaires
- •Mothers older than 18 years of age
排除标准
- •Infant with cranial abnormality/neurological squeal such as cystic periventricular leukomalacia (PVL) and intraventricular haemorrhage (IVH)
- •Maternal history of drug or alcohol abuse or severe psychiatric disorders before or during pregnancy
- •Infant with congenital anomalies
- •Infant with hearing or vision loss
- •Mother and infant participating in another clinical trial
研究组 & 干预措施
Heart Rate Variability Biofeedback
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
干预措施: Heart rate variability biofeedback (Device)
结局指标
主要结局
Satisfaction Regarding the Intervention
时间窗: After completing the HRVB program (on average 3 weeks)
Satisfaction will be measured through a questionnaire. Questions will be asked about global satisfaction, utility, timing and difficulty about their experience (assessed on single item Likert scale). Higher scores reflects more satisfaction. Possible range 2 to 10.
Feasibility: Acceptance (Ratio)
时间窗: After completing the HRVB program (on average 3 weeks)
The ratio of acceptance of study participation (number of participants who accept to participate to the study / number of participants to whom the study has been proposed) \* 100
Feasibility: Drop-out
时间窗: After completing the HRVB program (on average 3 weeks)
The ratio of drop out.
Feasibility: Number of Sessions Completed During Study
时间窗: After completing the HRVB program (on average 3 weeks)
Compliance with study protocol regarding the number of sessions attended by the participants.
次要结局
- HRV: HF(Before and after completing the HRVB program (on average 3 weeks).)
- Stress(Before and after completing the HRVB program (on average 3 weeks).)
- PTSD(Before and after completing the HRVB program (on average 3 weeks).)
- Anxiety(Before and after completing the HRVB program (on average 3 weeks).)
- HRV: RMSDD(Before and after completing the HRVB program (on average 3 weeks).)
- Depression(Before and after completing the HRVB program (on average 3 weeks).)
研究者
Urben Sébastien
Head of Research Unit, University Service of Child and Adolescent Psychiatry
University of Lausanne Hospitals