ICU (Intensive Care for Adults)
Conditions
Interventions
This study aims to characterize the acoustic environment and its impact on its users, serving as a baseline for comparing potential future soundscape design suggestions (SASICU – Phase II). Notably, t
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: = 18 years old> 24 hours of ICU Length of Stay (LOS)No reported hearing loss in their medical history; no hearing aids in placeA sufficient level of Dutch (equivalent to B2 language proficiency level) to complete the data collection processes
Exclusion criteria
Exclusion criteria: Primary neurological condition as reason for ICU admission precluding stress and anxiety assessmentsHistory of Post-Traumatic Stress Disorder (PTSD)Schizophrenia or other psychiatric diseasesComa after cardiac arrestA medical instable situation such as resuscitation, or in the dying process
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Considering sound levels and alarm logs as independent variables, the current project aims to explore the impact of alarm prevalence on main parameters such as patient well-being and stress, health outcomes, sleep quality and symptoms of anxiety and depression. Wellbeing, stress, and anxiety will be assessed through:Primary endpoint:The State and Trait Anxiety Inventory (STAI-6), developed by Marteau & Bekker (1992) is a 6-item self-report questionnaire designed to evaluate the respondent’s current emotional state, reflecting how they feel at the present moment. Each item will be rated on a 4-point Likert scale ranging from 1 (“not at all”/ “almost never”) to 4 (“very much so”/ “almost always”). Due to its brevity, the completion time for the STAI-6 is expected to be less than two minutes (Julian, 2011). Secondary endpoints:Patient physiological data, including HRV and RR, which will be collected automatically and continuously through the patient’s monitor and exported via Taperec, an EMC application. This data set will provide the ECG data for calculating Heart Rate Variability (HRV) and respiratory rate which are to be used to determine physiological stress. The medical devices have their own data logs which can be outputted upon request. Medical data is also stored in the HiX system (electronic patient data management) outside of the medical devices which can be collected retrospectively once the patient gives consent.Glucose levels that will be collected daily, and through cortisol levels by saliva swabs per each shift. Salivary cortisol levels will be taken during routine handling once in every shift (e.g., at 9.00 – 16.00 – 24.00 hours) by the nurse via swabbing and stored by the laboratory until final determination in a single bath process. Blood samples for glucose level measurement will be collected daily at 6:00 as part of the routine care procedure.Sleep quality will be measured through:Primary endpoint:The Richards-Campbell Sleep | — |
Secondary
| Measure | Time frame |
|---|---|
| Acoustical environment: Acoustic data will be collected in an automated way via SoundEar 3-300 which is a sound level meter that measures the sound pressure (Fast/Slow and A/C weighted) regularly with a frequency of one measurement per second. For the Fast-Weighted data, 8 values per second are available. This sound measurement technique is the safest for patient privacy as the dB data is non-identifiable and the registered scores can range between 10dB (quiet) – 120dB (pain threshold) with an expected average of 55dB. The study will take six months per phase (i.e., before and after technical intervention) however, data collection is 24/7 and will be reorganized per patient and their stay. The eight acoustic devices (each in every single patient room in Unit C at the Adult ICU of EMC) will be connected to the Erasmus MC network and all acoustic data will be stored in the specific Erasmus MC server. We are planning to have a folder named \\storage.erasmusmc.nl\MyDocs\Research Project SASICU and data can be retrieved upon request. This data collection is continuous.Alarms: Alarm logs will be retrieved from the ASCOM Unite Analyze database. The provided file contains information about the bed number, the medical device emitting the alarm, its duration, and its message. Patient monitor alarms also have information about their severity, such as blue, yellow, or red alarms.Soundscape assessment:It will be conducted using a brief eight-item questionnaire based on the soundscape standard ISO/TS 12913-2:2018, Method A, which has been translated and validated in Dutch by van den Bosch et al. (2023). This questionnaire aims to evaluate patients’ perceptions of the acoustic environment across various dimensions, including Eventful, Vibrant, Pleasant, Calm, Uneventful, Monotonous, Annoying, and Chaotic. Each attribute will be rated on a 5-Point Likert scale. Additionally, users will be asked three more questions included in the ISO/TS-12913-2, 2018 Metho | — |
Countries
Netherlands
Contacts
Public ContactE. Fasllija
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed