Mindful Kangaroo Care: Mindfulness Intervention for Mothers During Skin-to-skin Care
Condition: Stress; Anxiety; Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Mindfulness offers a way to focus on being in the moment and accepting the present moment in
      a non-judgemental and compassionate manner. Mindfulness has been shown to reduce stress in
      parents of babies admitted to NICU.

      This pilot study is planned to explore the opportunity of teaching Mindfulness skills to
      mothers providing KMC and studying its effects on maternal stress and distraction. To our
      knowledge, there are no scientific studies that evaluated mindfulness during kangaroo care or
      skin-to-skin care.

      OBJECTIVE

      To explore the feasibility and acceptability of practicing Mindfulness while giving Kangaroo
      mother care - "Mindful Kangaroo care"

      To explore potential benefits of Mindful Kangaroo care, such as stress reduction, change in
      mindfulness state, variation in screening for depression and anxiety and overall satisfaction
      with this practice

      MATERIALS AND METHODS

      This study is a non-blinded, prospective, observational pilot randomized controlled study.

      Inclusion and Exclusion Criteria

      Postpartum mothers whose baby is receiving care at the Stollery Children Hospital NICU, Royal
      Alexandra site, are eligible to enter the study.

      Mothers would be eligible to participate

      a) if they speak, read and write English, b) if their baby is anticipated to require a NICU
      stay of at least 4 weeks following recruitment, c) if the baby's medical condition allows for
      skin-to-skin care at recruitment, d) 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.

      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.

      We aim to recruit 30 participants, 15 in both groups.

      Procedure

      Once recruited, mothers will be randomized into the mindful kangaroo care intervention group
      or into the no intervention kangaroo care group. To ensure prior experience with skin-to-skin
      care, data collection in both groups will begin after the mother has had at least two
      skin-to-skin experiences with her baby.

      Interventions

      Mindful Kangaroo Care Group (MKCG)

      All research team members are mindfulness practitioners and/or coaches. Some of the
      researchers would instruct and support weekly, one-on-one, all mothers in their mindfulness
      practices over a period of 4 weeks.

      The MKCG will involve four face-to-face direct coaching on Mindfulness techniques at weekly
      intervals. The following will be the broad theme of each coaching session

      Week 1 - On the first encounter, the mothers will learn how to practice an introductory
      mindfulness technique to develop the awareness of any sensations felt in the body while
      holding their baby.

      Week 2 - On the second encounter, the mothers will learn how to practice a second mindfulness
      technique to create positive feelings in the body while holding their baby.

      During the third and fourth weekly encounters, the mothers will have a chance to ask their
      questions and explore further both mindfulness techniques as needed.

      Control Group (CG)

      Standard of care will be offered to all mothers in the control group which includes kangaroo
      care but does not involve any mindfulness practices.

      The following instruments will be given for the mothers to complete to study the feasibility,
      acceptability and effect on stress.

      Power analysis will not be done because of the pilot study nature; a goal of recruiting a
      convenience sample of 30 mothers is set. The 30 possible participants will be randomized in a
      1:1 ratio (15 participants to each group) at the time of enrollment.

      Instruments

        -  General Demographics Form: A researcher created maternal demographic data form (age,
           educational level, number of gestations, parity, prior experience with kangaroo care
           with other children, history of depression/anxiety, gestational age at baby's birth,
           birth weight, delivery type and infant age at first skin-to-skin experience) to be
           completed by the mother at enrollment.

        -  Kangaroo care log: Document recording timing and duration of kangaroo care. Document
           whether or not the intervention (mindfulness) is practiced using a single-item, 5-point
           Likert scale (0%, 25%, 50%, 75% or 100% of kangaroo care"). Document how long they used
           their phones, talk to someone and slept off while doing KMC using the same scale.
           Document satisfaction with Kangaroo Care for each session using a single-item, 5-point
           Likert scale ("Very dissatisfied" to "Very satisfied") measuring mother satisfaction
           with kangaroo care and a space to write any comments. Log to be completed by the mother
           weekly throughout the study time.

        -  Mindfulness scale: Toronto Mindfulness Scale as described above to be completed by the
           mother once at enrollment and at the end of the four weeks. An option will be added to
           allow the participant to express that she does not understand the statement on the
           scale.

        -  Stress scale: Neonatal Unit Parental Stressor Scale as described above, to be completed
           by the mother once at enrollment and at the end of the four weeks.

        -  Depression and Anxiety scale: Patient Health Questionnaire 4, as described above, to be
           completed by the mother once at enrollment and at the end of the four weeks.

        -  Feasibility form: A researcher created a data form to evaluate the recruitment
           capability, the data collection procedures and outcome measures, the resources and
           ability to manage and implement the study and intervention, to be completed by the
           investigators throughout the study time.

        -  Acceptability form: A researcher created a 3-point Likert scale ("unacceptable" to
           "acceptable") measuring mother acceptability to the different instruments (demographic
           form and the outcome scales) and acceptability to the intervention, to be completed by
           the mother at the end of the four weeks.

      Statistical analyses

      Descriptive statistics will be calculated to summarize sample characteristics and will be
      compared between groups. Appropriate statistical tests (independent and paired t-tests,
      Wilcoxon signed-rank test, Mann-Whitney U tests and χ2 tests) will be used to examine for
      differences between study group demographics, for differences between groups independent
      study variables (parent stress score, mindfulness score), and for within-group changes in
      both scores from before to after the intervention. Given our small sample size, we are
      primarily interested in exploring the direction of any effects. Feasibility data will be
      analyzed by descriptive statistics where appropriate and qualitatively where appropriate.
      Acceptability data will be evaluated using descriptive statistics.

      Possible Risks:

      The risk is minimal. Mindfulness practice trains the brain to develop attention skills. There
      might be challenges that may arise during mindfulness meditation. Those challenges are
      usually the same that arise during normal daily life. When they occur during mindfulness,
      they become opportunities to develop insight. Should a mother had an overwhelming experience,
      the people offering mindfulness instructions to her would be able to help her. Moreover, the
      social workers on our unit are trained to respond to acute distress, they are aware of this
      research project and are willing to support the mothers as needed.

      Possible Benefits:

      There may or may not be a direct benefit to the mothers from taking part in this study. Some
      people experience less stress, less anxiety, less intrusive thoughts, less confusion or less
      foggy mind with a mindfulness practice. Some people experience more satisfaction, more
      fulfilment, or they become more aware of their emotions, more aware of their thinking
      process, more presence in their interactions and relationships. The information that we will
      gather may improve the care of other mothers.
    

Intervention name(s): Mindfulness
Intervention type(s): Behavioral
Intervention description(s): Mindfulness techniques will be taught to the participants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care