BIG-5 study
Recruiting
- Conditions
- ot applicable
- Registration Number
- NL-OMON23999
- Lead Sponsor
- Erasmus MC, University Medical Center Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Patients aged = 16 years admitted to the nursing ward and will undergo or has undergone a surgical procedure including gastro-intestinal, hepatobiliary, pancreatic, endocrine, trauma, vascular, liver- and kidney- transplantation (both receiver and donor).
-Sufficient knowledge of the Dutch language.
-Communicable and able to assess the questionnaires.
-Written informed consent is acquired from the patient.
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Participation in another study that may possibly intervene with any of the outcome measures.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anxiety using the State-Trait Anxiety Inventory (STAI-6) questionnaire, Subclinical stress using the Subclinical Stress Symptoms Questionnaire (SSQ-25), sleep quality using the adapted Dutch-Flemish Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance version 1.0 questionnaire, perioperative pain using the Numeric Rating Scale (NRS), postoperative risk for delirium using Delirium Observation Screening (DOS).
- Secondary Outcome Measures
Name Time Method Daytime sleepiness using the Epworth Sleepiness Scale (ESS), physical parameters, complications during hospital stay, medication requirement, hospital length of stay, 30-day mortality.