A physiological measure of nociceptive pain for persons with severe and profound intellectual and motor disability (SID)

In earlier research a sock was adorned with sensors detecting galvanic skin
response (a *smart sock*) which was then used to measure arousal in persons
with intellectual disability (ID). A accompanying *flower app* was created to
show the amount of arousal of the wearer of the sock to their parent or another
caregiver.
Parents and professional caregivers of persons with severe ID acknowledged the
usefulness of the *smart sock* and *flower app*, but wondered whether the sock
and app could not be adjusted to measure pain instead. They agree that pain is
difficult to observe in persons with severe intellectual and motor disability
(SID), because expressive and communicative skills are extremely limited. A
physiological measure of acute pain could really improve the lives and
happiness of persons with SID.
This study is set up to see whether a *smart sock* can reliably be used to
detect pain in persons with severe intellectual disability. We hypothesize that
nociceptive (acute) pain can be measured with galvanic skin response, that this
pain will physiologically be detected faster than observational measures, that
caregivers will adjust their treatment when given a *pain* warning, and that
parents and professional caregivers will see the *smart sock* and *SID Pain
App* as a useful tool, but a tool which does not need to be used continuously.

The study*s main objective is the creation and testing of a *SID Pain App* that
in connection with a *smart sock* will fast and reliably detect nociceptive
pain in persons with severe intellectual and motor disability (SID).

This study will include experiments, observations and interviews. Pain will be
experimentally induced in participants without ID to test the *smart sock* and
*SID Pain App*. Persons with SID will be observed while wearing the *smart
sock* during moments when they may and may not experience pain, and during
moments when the sock is and is not connected to the *SID Pain App*. And
parents of persons with SID will be interviewed about their experiences and
contentment with the use of the *SID Pain App*.

The intervention used in this study is for the third research question. In this
study, 4 persons with SID will be videotaped during two care moments while they
are wearing the *smart sock*. The smart sock will be connected to the *SID Pain
App* in only one of the two care moments. The fact that the (professional)
caregiver will be given a signal when the person he or she cares for is in pain
can be seen as an interventive measure. The purpose is to see whether treatment
is adjusted faster and in a different manner when the caregiver knows the
action that is taken is causing pain, and whether the client will seem happier
and explore more when care is adjusted.

Burden: Low. The participants with SID will wear a smart sock and ankle band,
and will be video taped during a care moment that would have happened
regardless. The participants without SID will get two short painful experiences
which will not lead to temporary or permanent damage, and they will be asked to
fill out a short questionnaire (< 5 minutes). Caregivers will fill out a
questionnaire twice (<15 minutes). Parents will be interviewed once about their
experiences (45 - 75 minutes).

Risk: Low to moderate. The use of the smart sock has a minimal risk. The two
most likely risks are an allergic reaction in case of an (unknown) allergy and
an ankle band that is pulled too tight. The first risk will be minimized by
filtering participants with allergies, and the second will be met by a thorough
instruction and monitoring by the research assistants.
Participants without SID will receive a pain experience with a safe
non-invasive method which will not lead to any temporary or permanent damage.
Participants might react extremely to the pain stimulus. Calamities will be
dealt with and medical personnel will be invited when necessary. Participants
will be thoroughly looked after, both during and after the study, and during
the study (medical) help will always be close by.
Electrical safety will be especially assessed when working with water.

Group relatedness: This (medical) aid will be made available especially for
those persons who are unable to express and communicate their pain. In order to
test the effectiveness, we will have to test the system in this group (those
persons with SID). Without their participation we will only know the
effectiveness of the system in participants without SID.