Development of an experimental model for continuous measurement of postsurgical patient wellbeing, a pilot study.
- Conditions
- Wellbeing1004099110043413
- Registration Number
- NL-OMON45404
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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.
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Continuous monitoring with the healthpatch biosensor during both stays:<br /><br>o Physical activity: number of steps, activity, total activity (cumulative, per<br /><br>time of day, peak)<br /><br>o Sleep quality: total sleep duration, total duration of rapid eye movement<br /><br>(REM) sleep, number of nightly awakenings<br /><br>o Stress level: calculated stress index (SI) (average, hourly).<br /><br><br /><br>Questionnaires at three moments during both stays:<br /><br>o State Trait Anxiety Inventory (STAI)<br /><br>o Visual Analogue Scale (VAS): measuring patient-reported outcomes of energy<br /><br>level and physical mobility<br /><br><br /><br>Measurements of pain processing, thresholds and suppression capabilities during<br /><br>both stays:<br /><br>o Quantative Sensory Testing (QST). QST measurements include pressure pain<br /><br>threshold (PPT), electric pain threshold (EPT) and Conditioned Pain Modulation<br /><br>(CPM).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Participants fill in a daily diary of their activities for further validation<br /><br>and interpretation of the data from the HealthPatch biosensor.<br /><br>Participants are also invited for a short interview about their personal<br /><br>experiences and opinions during their hospitalization.<br /><br>Questionnaire about sleep: Leeds Sleep Evaluation Questionnaire (LSEQ)</p><br>