No registrations found.
ID
Source
Brief title
Health condition
Not applicable
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Daytime sleepiness using the Epworth Sleepiness Scale (ESS), physical parameters, complications during hospital stay, medication requirement, hospital length of stay, 30-day mortality.
Background summary
Rationale: A great number of surgical interventions are performed in the Netherlands. Perioperative anxiety, pain, stress, sleep disturbances and delirium in the older patient seem to be the most common in-hospital factors disturbing the patients mental state of wellbeing, which negatively influence recovery and should be prevented. Unfortunately, little is known about the prevalence and severity of these factors, regardless of their negative effects for the patient. In addition, the awareness of health care professionals of these factors seems to be very low. Therefore this prospective cohort study will evaluate the prevalence and severity of these factors and study correlations between the severity and health related outcomes in hospitalized surgical patients.
Objective: To assess the prevalence and severity of anxiety, stress, pain, sleep disturbances, and delirium in adult surgical patients using questionnaires and electronic medical records.
Study design: A prospective cohort study.
Study population: Patients ≥ 16 years of age treated at the department of surgery in the Erasmus MC.
Main study parameters/endpoints: Prevalence and severity of anxiety, stress, pain, sleep disturbances and delirium in adults surgical patients.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks in participating in this study. Benefits include adequate detection and management of anxiety, stress, pain, sleep disturbances and delirium for future in-hospital surgical patients.
Study objective
Data on these complications vary. Since this is an observational study, we are interested in overall incidence and prevalence. Therefore we do not have a clear hypothesis.
Study design
Inclusion during hospital stay, both pre- and postoperative. Survey collection will take place daily until day 14 of study participation. From day 15, survey collection will be every other day until the day of discharge, or until day 30 of study participation.
Intervention
None
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.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL9114 |
| Other | METC Erasmus MC : MEC-2020-0833 |