Development of an experimental model for continuous measurement of postsurgical patient wellbeing, a pilot study.

Development of an experimental model for continuous measurement of postsurgical patient wellbeing, a pilot study. - An experimental model for measuring postsurgical wellbeing.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45404

Enrollment

Registered

2017-03-06

Start date

2017-07-03

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wellbeing

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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)	—

Countries

Netherlands

Outcome results