The two main objectives are: A) identify patterns of psychofysiological stress in staff and clients prior to challenging behaviour, and B) explore possibilities of biofeedback on the psychofysiological stress level of staff, and whether biofeedback…
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Psychofysiologische stress, measured with the markers heart rate variability
and skin conductance
- incidents of challenging behaviour
Secondary outcome
- self reported stress (staff)
- mood (client)
Background summary
Stress in both clients and staff often precedes challenging behaviour in
clients with severe to profound intellectual disabilities. Clients need support
from staff to cope with stress, while staff report difficulties in recognizing
client stress. Additionally, clients' challenging behaviour often causes staff
stress, and staff stress negatively affects staff-client interactions. Despite
the general acknowledgment of the role of stress in supporting clients,
characteristics of this process remain unclear.The possibilities to measure
psychofysiological stress in an easy, non-intrusive and objective way increased
through the development of wireless devices in the last years. The devices can
also give biofeedback on psychofysiological markers of stress to improve
insights into stress levels.
Study objective
The two main objectives are: A) identify patterns of psychofysiological stress
in staff and clients prior to challenging behaviour, and B) explore
possibilities of biofeedback on the psychofysiological stress level of staff,
and whether biofeedback enables staff to recognize and regulate stress, and
possibly decrease challenging behaviour. The expectation is that: A) stress
increases prior to challenging behaviour in both staff and clients, and staff
and client stress influence each other reciprocally, and B) stress recognition
and regulation improves in staff, followed by a decrease in challenging
behaviour.
Study design
Phase A: 15 single case studies are performed in which one case is a dyad of
one client and one staff member. Staff-client dyads wear the E4 wristband two
times a week during 3 hours on 20 days.
Phase B: again 15 single case studies are performed in the same 15 staff-client
dyads. The series N=1 studies will be integrated in a combined series design,
consisting of a baseline phase (5 to 9 day), an intervention phase (20 sessions
of 3 hours) and a follow-up phase (3 weeks and 3 months). The staff members
wears the Polar M600 in each phase, while biofeedback is given in the
intervention phase only. Clients wear no wireless device in phase B.
Intervention
Sense-IT is an app using a smartwatch and smartphone. The smartwatch measures
heart rate, and shows this on a scale from 1 to 10. A baseline measurement is
carried out in rest. Then a personalized threshold is determined to inform the
participant about increasing or decreasing stress levels, (i.e. changes of .5 1
or 2 standard deviations). The smartwatch informs the staff member visually
and/or through a vibration about changing stress levels, controlled for
physical activities.
Study burden and risks
Deelname aan het onderzoek vereist minimale extra belasting voor begeleiders.
De E4 wristband (deelstudie A) en de Polar M600 met biofeedback interventie
(deelstudie B) worden gedragen tijdens het gewone dagprogramma. De extra
belasting zit in het om en afdoen van de E4 wristband bij de cliënt in
deelstudie A, en het invullen van de vragenlijsten in deelstudie A en B. De
vragenlijsten sluiten aan bij de al bestaande rapportages die begeleiders
uitvoeren bij EVB+ cliënten. Invullen van de vragenlijsten duurt 5 tot 10
minuten per keer.
Het nadeel van deelname is dat het dragen van het horloge mogelijk tot onrust
leidt bij de EVB+ cliënt en begeleider. In de begeleiding van EVB+ cliënten kan
elke aanpassing in de dagelijkse routine gezien worden als een stressor en
daarom voor moeilijk verstaanbaar gedrag zorgen. Voor de begeleider kan deze
extra taak ook spanning geven. Om het niveau van spanning door het dragen van
het horloge te minimaliseren maken we gebruik van een protocol voor het
inzetten van het draagbare wireless device dat speciaal ontwikkeld is voor deze
doelgroep en wordt gepersonaliseerd op de cliënt. Een eerdere feasibility
studie toonde de mogelijkheid van het inzetten van het draagbare wireless
device bij EVB+ cliënten aan.
Oudlaan 4
Utrecht 3515 GA
NL
Oudlaan 4
Utrecht 3515 GA
NL
Listed location countries
Age
Inclusion criteria
Client: 18-65 years old, IQ<=40, client who receive "Meerzorg", admitted for at
least 3 months, clients with recurrent challenging behaviour
Staff: works minimally 2 days per week with te client
Exclusion criteria
Client: high risk that the client will damage the smartwatch, using
beta-blockers
Staff: using beta-blockers
Design
Recruitment
Medical products/devices used
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In other registers
Register | ID |
---|---|
CCMO | NL71683.091.19 |