Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04696770 |
| Other study ID # |
Pro00089053 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2019 |
| Est. completion date |
March 1, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
