Hi, I'm Sabrina Hauser and I'm presenting this paper published
at the ACM CHI 2020 conference on behalf of my author team. We
describe the design and deployment of Calmer, which is
an actuated platform device placed in an incubator,
administering breathing motion, heartbeat sounds, and skin-like
tactility to simulate maternal skin-to-skin holding to a
prematurely born infant lying on it.
We report and reflect on our 10-year design path of creating
this technology. We detail what motivated us to design this
device, give insight into our approach, go into details about
the physical design and its iterations and also describe how
we introduce it into the neonatal intensive care unit -
the NICU.
We present findings from testing Calmer in a pilot deployment, a
randomized clinical trial to demonstrate efficacy, and
qualitative interview study. As we report and reflect on our
work, we extract key take-aways from our approach to designing
Calmer, carefully considering the socially and technologically
complex context.
With this in mind, I'd like to directly point to how the Calmer
project offers a unique design case to the HCI community.
Calmer is an exemplar of replicating an intimate human
behavior and moment that is at the core essence of what it
means to be human.
This seems nearly unreplicable: a mother holding her prematurely
born fragile infant, the infant experiencing the warmth, the
breathing, and the heartbeat of the mother. Yet looking at
Calmer, we wouldn't assume that but instead we see a plastic
platform.
The long-term persistent engagement over 10 years to
designing this technology resembles a strategy that
includes cautiously and well considered contextual, social,
and medical ecological needs of the various stakeholders and
their situations. This includes the premature infants, parents
and medical staff.
A considerable focus in our work became the objective of
replicating, yet importantly, not replacing maternal holding,
an intimate human action and practice offered at a time of
fear, hope, life or death, and with challenges around
significant maternal stress.
Calmer contributes to HCI strategies to designing for the
NICU and broader hospital context, to conscious and
empathic automation of human actions,
and to design-led research targeting product development in
a vital context.
In the remainder of this presentation, I will highlight
some of the main parts of our paper. Specifically, I will
speak about the clinical background and context, give
highlights of the design iterations and evaluations, and
then discuss some of the key take-aways. There's a lot of
nuance and details in the paper and this will only be a glimpse
of that.
Each year worldwide over 15 million infants are born
preterm, separated physically from their mother to ensure
their survival. These infants can remain in the queue for
weeks to months, repeatedly undergoing essential but painful
care-related procedures such as blood tests.
Some infants may be subjected to up to 15 painful procedures like
that a day. This early stress has severe effects on neonates.
It can induce long term damage to many developing systems, and
it can also have damaging effects on parents.
Pharmaceutical medications have limited efficacy for
procedure-related pain in premature infants. And so
instead maternal skin-to-skin holding is recommended as a
powerful alternative.
When a mother holds her infant on her chest where it
experiences the touch and warmth of her skin, the sound of her
heartbeat, and breathing motion of her chest as much as 50% of
pink can be reduced.
The components of skin-to-skin holding simultaneously activate
multiple opioid and non-opioid pathways to reduce pain.
However, parents cannot always be at bedside, they may have
competing responsibilities, or their infant may receive care
far away from home. And yet, even when parents are present,
there are still further barriers to skin-to-skin holding. For
example, infants maybe too medically unstable to be held
and instead have to stay in the incubator.
An alternative being used in some NICUs is facilitated
tucking, a human touch-based holding strategy. However, this
strategy can be hard for busy NICU staff to provide for every
procedure.
And this is where our project team of clinicians and
researchers saw a potentially high impact design opportunity
in physically simulating key aspects of maternal skin-to-skin
holding for premature infants when a parent is not present.
In what follows, I'll speak briefly to the initiation of the
project, detail our guiding objectives and requirements, and
report on Calmer's design stages along with the different ways to
we deployed and studied two Calmer prototypes.
The Calmer project came about through a serendipitous
encounter of a neonatal pain researcher, who was also a
former NICU occupational therapist, and a haptics
human-robot interaction researcher. It was inspired by
furry breathing robots part of an affective computing and
robotics project. We talk more about this in the paper.
From the start, the primary goal of the Calmer project has been
to design and build a device that reduces pain in preterm
infants by simulating key aspects of maternal skin-to-skin
holding, and as a result potentially alter the standard
of care and neonatal pain therapy.
Importantly, part of this goal has been to consider a conscious
and careful integration with the technological and social
complexities of the NICU environment. Three core design
objectives were developed aligning with this main goal.
The technology we wanted to design had to conform to the
needs and practices of multiple users and stakeholders. Although
the experience of maternal holding is targeted at infants,
our prototypes had to work for parents and NICU staff as well.
We knew that it would be unacceptable for this technology
to be perceived as replacing parents. Not only could it be
rejected by parents, but also staff because of the strong
philosophical approach in NICUs promoting family-centered care.
For instance, in light of this objective, we realized we had to
defuse the appearance of life-asserting cues, yet still
provide them to the infant.
We also knew a medical technology concept like Calmer
could not proceed without clinical validation. So it was
important for us to work towards an eventual randomized clinical
trial.
With these objectives, a first prototype was developed to
explore and demonstrate the feasibility of our developing
concept with limited resources.
Our approach was to simulate putative pain-mitigating
components of money
skin-to-skin holding through the modalities of breathing, motion,
heartbeat, sound, and skin touch using tactile, auditory and
kinesthetic stimuli. This define four technical subsystems.
In this first prototype, we also explore the option of Calmer
using an individual mother's breathing and heart rate. This
kind of personalization was something we wanted to explore
as a form of integrating mothers into the technology that was
simulating them. It ended up being a quite powerful move
towards avoiding mothers feeling replaced.
All components were hygienic and cleanable to NICU standards.
While we did not expect this prototype to support a clinical
efficacy trial, we wanted to assess our design and
engineering approach and get a sense of how infants, parents
and staff would respond to it. For that, we conducted an
initial randomized pilot evaluation on 10 infants using
Calmer for pain reduction during a single medically necessary
blood test.
We share more details on this study in our paper and there is
also a medical paper published with our results.
While the sample was too small to statistically determine
efficacy, the data was encouraging. And this was an
important step to the project's future and to secure further
funding that would support a more sophisticated prototype
iteration and a larger clinical trial.
For this next move, we generated a list of desired improvements
from staff and feedback and our own perspective. And we guided a
professional engineering team and developing the second
prototype over the course of 18 months.
Wwith the goal of conducting a larger clinical trial, the
second iteration on Calmer demanded greater NICU
operability. We needed to maintain infants on the device
for longer periods of time, and that in turn led to many new
requirements and changes. We had to change the power source for
better flexibility and mobility. All materials had to be X-ray
compatible.
The skin-simulating covering was exchanged to improve infant
comfort and mobility and to have less of a skin-tone color.
A custom controller for more compact and streamlined access
was developed, and an emergency stop button added to allow for
performing CPR on an infant. And a series of tests were done to
confirm the prototype could meet robustness requirements.
With the new device, we ran a single-site randomized clinical
trial with 49 infants to determine Calmer's efficacy.
The trial showed that Calmer was as effective as facilitated
tucking for reducing pain during a single blood test, and hence a
viable alternative. These positive results lead to two
granted patents and our hope is that the Calmer technology will
eventually be implemented in incubator designs worldwide.
Again, we share more details on this study in the paper and
there is also another medical paper published reporting on the
trial results.
In addition to studying Calmer's efficacy, we wanted to examine
its acceptability and the user experience from the perspective
of both NICU staff and parents and investigate how well it
catered to the social complexities and context of the
NICU.
We addressed this objective with a qualitative study conducted in
parallel with the clinical trial.
We interviewed 10 mothers of preterm infants who experienced
Calmer in our clinical trial and 10 NICU staff who cared for
them. We looked at the fit of Calmer in the NICU, and their
perceptions and experience of it.
Staff reported that Calmer was not perceived as an obstacle in
their work. Mothers reported appreciation of Calmer's
mimicking features, its potential to strengthen the
infant-mother bond, and that they perceived it as looking
like a discreet non-threatening bed. This was really positive
because they didn't perceive it as a replacement, but rather as
a back-up and this positive experience and perception of
Calmer by staff and parents was extremely important to the
success of this technology design.
To give you a brief glimpse of the kind of take-aways we
discuss in our paper, I will touch on those now.
We believe the background and circumstances in our project
mattered. The way the project came about initially was
remarkably defining as the main idea developed from that initial
serendipitous encounter, and the two different experts joining
forces.
Access and iterative design based on feedback on prototypes
was impractical, nearly impossible. Due to the
challenging context and environment in this project,
which had to be treated with extreme caution.
Various work-arounds had to be developed.
For instance, we capitalized on team members diverse expertise
and multidisciplinary experiences; stakeholder input
was often covered by our own team.
With Calmer the premature infant experiences the haptics features
somewhat passively with our design feedback being metrics on
pain reduction. At the same time, others, in particular
parents and NICU staff, experience the device interface
more actively in a social or workflow sense. Yet, they do not
experience the haptic features. This was a challenge unique to
this project as typically the person was designing for would
be the person who would feel and interact with the haptic
features being built.
A key part of the objectives and designing Calmer was to
replicate maternal skin-to-skin holding in a conscious and
empathic and integrative way.
The surprise to us was that this small symbolic gesture of using
a mother's individual heart and breathing rate programmed into
Calmer when her infant was lying on it was so powerful. This act
of sampling made mothers feel supported, even channeled
through Calmer rather than supplanted.
Although Calmer was perceived as a welcome back-up of mothers
rather than provoking uncanny feelings, we would not argue
that deliberately mimicking pieces of a human, even if done
carefully as we did in Calmer, always has a place.
As I mentioned at the beginning of this presentation, Calmer is
emblematic of its strategy and features and presents a unique
design case to the HCI community.
The project reports on a long-term process of designing
in a complicated space, considering the conscious and
empathic automation of human action.
The Calmer project can inform further work and discussions in
haptics research, in automating or replicating human actions, as
well as design work for the NICU and broader hospital context.
Our work also shows how Research through Design can play an
important role in a vital context. Calmer is a Research to
Design exemplar of an innovation targeting commercialization, and
we continue to work with this aspiration. This project is
ongoing and we are working on a third version of Calmer and
future studies.
Thank you for watching and we'd also like to thank our funding
bodies, our review chairs and reviewers, and the awards
committee for honoring our work with a Best Paper Award.
Please go to the ACM Digital Library and read our full paper
and reach out to us if you wish.