跳至主要内容
临床试验/NCT04696770
NCT04696770已完成不适用

Mindful Kangaroo Care: Mindfulness Intervention for Mothers During Skin-to-skin Care

University of Alberta2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Change in stress symptoms

研究概览

简要总结

Very high levels of stress have been reported in parents with their infants admitted to Neonatal Intensive Care Unit (NICU). Review of literature shows that the symptoms are consistent with Post-Traumatic Stress Disorder (PTSD), Acute Stress Disorder and many parents have depression that lasts longer than a month. Skin-to-skin care offers many benefits to the mother and the infant including reduction of maternal stress. However, it has been observed that mothers giving skin-to-skin care for preterm infants in an NICU environment focus on the cardiorespiratory monitoring and its alarms instead of focusing on the baby and "being in the moment". There have also been other challenges noted with maternal sleep while providing skin-to-skin and parental distraction on hand-held devices while providing skin-to-skin. Mindfulness offers a way to focus on being in the moment and accepting the present moment in a non-judgmental and compassionate manner. Mindfulness has been shown to reduce stress in parents of babies admitted to NICU.

To date, they are no studies looking at Mindfulness during skin-to-skin care. This study will explore the feasibility and acceptability of teaching mindfulness skills to mothers providing skin-to-skin care and studying its effects on maternal stress and distraction.

This study involves providing Mindfulness-based strategies during skin-to-skin care to NICU mothers for four consecutive weeks. Participants will be enrolled through informed consent. All participants will be given pre and post participation questionnaires to examine the impact of the sessions on stress reduction, mental wellness and mindfulness quotient. The participants will also be encouraged to maintain a weekly kangaroo care log. Participants will be asked to fill out an acceptability form at the end of the 4 weeks. The data will be analyzed to study the effect of mindfulness on stress reduction and mental wellness. The study will also help understand the uptake and acceptance of such a course by NICU mothers. The results of this study will lead to a future randomized controlled trial looking at the impact of mindfulness practise during skin-to-skin care on parental stress reduction.

详细描述

BACKGROUND

Kangaroo Mother Care (KMC) was developed to complement neonatal care for premature and low birth weight infants in areas where there were fewer resources. During KMC, a baby is positioned in skin-to-skin contact with the mother's (or father's) chest and each session may last for 30 minutes to a few hours or longer as tolerated. A recent meta-analysis concluded that KMC resulted in better thermal regulation, physiologic stability, enhance breastfeeding and also reduced mortality and infection. KMC has also been shown to improve mother-infant attachment and reduced maternal stress. KMC is widely practiced across the world. Skin-to-Skin care has also been identified with certain challenges and concerns, especially in the immediate neonatal period. There are several instances of the sudden unexpected postnatal collapse of babies reported. In most instances, these episodes were associated with inadequate standardization in selecting mother-baby dyads. There is a strong association with the baby's position, maternal sleep while KMC and inadequate monitoring during KMC. Maternal and neonatal fall while giving KMC has also reported as a concern especially associated with maternal sleep while providing KMC.

KMC in a NICU environment has its own challenges with barriers identified in a recent systematic review including, staffing issues, inadequate training available, difficulties in transferring babies for KMC while attached to infusion pumps and ventilators, stress among caregivers and families. It has also been observed that mothers giving KMC for preterm infants in a NICU environment focus on the cardiorespiratory monitoring and its alarms instead of focusing on the baby and "being in the moment". There have also been other challenges noted with maternal sleep while providing KMC and parental distraction on hand-held devices while providing KMC.

Parents of babies admitted to the NICU undergo a lot of stress. A systematic review of the parental experience of having an infant in the NICU showed that parents experience anxiety and stress. Symptoms of acute stress disorder in 40% of mothers

7-10 days after the birth of the premature infant has been reported in a prospective observational study conducted here at the Stollery Children Hospital, Edmonton. Another study evaluated symptoms of post-traumatic stress disorder (PTSD) and found that 51% of mothers and 33% of fathers screened positive for PTSD.

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
None

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

  • Mothers would be eligible to participate
  • if they speak, read and write English,
  • if their baby is anticipated to require a NICU stay of at least 4 weeks following recruitment,
  • if the baby's medical condition allows for skin-to-skin care at recruitment,
  • if the mother is available to do regular kangaroo care during the next 4 weeks after recruitment and
  • if the mother is agreeable to receive some teaching for 30-45 minutes weekly during those four weeks.

排除标准

  • Mothers whose baby is experiencing imminent risk of death at recruitment will be excluded.
  • Mothers who reported current mental illness issues, current or prior substance abuse/addiction will be excluded.

结局指标

主要结局

Change in stress symptoms

时间窗: Change from recruitment to 4 weeks after

Using the Parental Stressor Scale for NICU parents. Parents rate the amount of stress. Scores for each question range from 1 (not at all stressful) to 5 (extremely stressful). A higher score indicates a higher level of stress.

Acceptability

时间窗: 4 weeks after recruitment

A researcher created 3-point Likert scale, measuring acceptability of the different instruments and mindfulness intervention during the research project

Change in depression symptoms

时间窗: Change from recruitment to 4 weeks after

Using the Patient Health Questionnaire 4. Scores for each question range from 1 (not at all) to 4 (nearly every day). A higher score suggests depression.

Change in anxiety symptoms

时间窗: Change from recruitment to 4 weeks after

Using the Patient Health Questionnaire 4. Scores for each question range from 1 (not at all) to 4 (nearly every day). A higher score suggests anxiety.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验