To investigate the effects of disturbing factors during postsurgical hospitalization on participants* wellbeing, in terms of sleep, stress, pain and physical mobility, and how this wellbeing might change during a more personalized hospital stay…
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Continuous monitoring with the healthpatch biosensor during both stays:
o Physical activity: number of steps, activity, total activity (cumulative, per
time of day, peak)
o Sleep quality: total sleep duration, total duration of rapid eye movement
(REM) sleep, number of nightly awakenings
o Stress level: calculated stress index (SI) (average, hourly).
Questionnaires at three moments during both stays:
o State Trait Anxiety Inventory (STAI)
o Visual Analogue Scale (VAS): measuring patient-reported outcomes of energy
level and physical mobility
Measurements of pain processing, thresholds and suppression capabilities during
both stays:
o Quantative Sensory Testing (QST). QST measurements include pressure pain
threshold (PPT), electric pain threshold (EPT) and Conditioned Pain Modulation
(CPM).
Secondary outcome
Participants fill in a daily diary of their activities for further validation
and interpretation of the data from the HealthPatch biosensor.
Participants are also invited for a short interview about their personal
experiences and opinions during their hospitalization.
Questionnaire about sleep: Leeds Sleep Evaluation Questionnaire (LSEQ)
Background summary
In light of innovation project 'Room with a View' of the surgical department of
Radboudumc, we aim to investigate the possibilities for improving postsurgical
wellbeing of patients. This wellbeing is defined by outcomes in mental stress,
pain, physical activity and sleep quality. (the 'BIG 4')
Study objective
To investigate the effects of disturbing factors during postsurgical
hospitalization on participants* wellbeing, in terms of sleep, stress, pain
and physical mobility, and how this wellbeing might change during a more
personalized hospital stay within an optimal healing environment.
Study design
A pilot study, non-randomized
Study burden and risks
The study requires a total time investment of 48 hours, which are spent on the
surgical ward of Radboudumc.
Aside from allergic or hypersensitivity reactions to the HealthPatch biosensor,
risks are considered minimal.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Participants must be at least 18 years old on the day the informed consent form will be signed.
Participants are able to speak, read and understand the local language of the investigational site, are familiar with the procedures of the study, and agree to participate in the study program by giving oral and written informed consent.
Exclusion criteria
History of cardiovascular diseases, arrhythmias or presence of implantable cardiac defibrillator.
History of sleep-related disorders.
History of allergic response or skin irritation in relation to adhesive bandages.
History of a (chronic) pain syndrome that interferes with the interpretation of QST results.
Participant has (a history of) a medical disorder that interferes with the study measurements or may pose a risk for the participant.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59593.091.16 |