Delirium, Intensive Care Unit, Randomised Controlled Trial
Conditions
Keywords
Delirium, sensory stimulation, intensive care unit, prevention
Brief summary
Delirium is highly associated with adverse clinical outcomes of intensive care unit (ICU) patients, including increased cognitive impairment, duration of intubation, ICU length of stay, mortality, physical dependence, and health care costs. This randomised controlled study will firstly develop a family-supported sensory stimulation package based on the literature review as well as the findings of the cross-sectional survey and the in-depth interview. The intervention effects than will be evaluated using outcomes including delirium incidence, delirium duration, delirium severity, ICU patients' consciousness and cognitive function as well as family members' satisfaction and anxiety. This study is expected to provide evidence of the effectiveness of family-supported sensory stimulation on preventing delirium among ICU patients.
Interventions
OTHERSensory stimulation
Sensory stimulation can be formed in different aspects, and the most important ones are visual stimulation and auditory stimulation. Visual stimulation interventions involved providing a calendar, clock or familiar objects such as photographs of family caregivers; while auditory stimulation included calling the name of patients, helping to orientate the time and location, introducing hospital information, the ICU surrounding and treatment, and communicating with patients, who could not talk due to artificial airway, through a blackboard and use of gestures.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessors will be blinded to the group allocation and will not be involved in data analysis and results reporting.
Intervention model description
An assessor-blinded two-arm randomised controlled trial (RCT) will be conducted.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years * the first time admitted to ICU * a Richmond Agitation-Sedation Scale (RASS) score ≥-3
Exclusion criteria
* diagnosed with stroke, dementia, delirium or acute psychiatric illness at admission * diagnosed with end-stage of cancer * severe hearing impairment and cannot be corrected by hearing aids * admitted to ICU with radiative material.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delirium incidence | Through study completion, an average of seven days | Delirium incidence means the number of patients who are delirious. |
| First occurrence of delirium | Through study completion, an average of seven days | First occurrence of delirium was defined as the first time that patients was delirium positive through CAM-ICU. The time to have the first occurrence of delirium was calculated from patients' admission to ICU to the first positive result of delirium assessment. |
| Delirium duration | Through study completion, an average of seven days | The delirium duration will be calculated when the patient is first considered to have delirium to the last time that patient is not supposed to have delirium based on CAM-ICU. |
| Delirium severity | Through study completion, an average of seven days | CAM-ICU-7 scores are further categorised as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-traumatic stress disorder (PTSD) | Through study completion, an average of seven days | The 17-item PTSD Checklist (PCL) correspond to the DSM-III-R symptoms of PTSD (post-traumatic stress disorder), which is a self-reporting scale for assessing PTSD (Frank et al., 1993; Mollica et al., 1992). Patients were asked for their agreement to describe each item, from one (not at all) to five (extremely). PTSD-symptoms could be divided into re-experiencing (flashback, nightmare, emotional cue reactivity, and physical cue reactivity), avoidance and emotional numbing (avoidance of thoughts and reminders, amnesia, loss of interest, detachment, restricted affect, and foreshortened future) and hyperarousal (irritability/anger, sleep disturbance, difficulty concentrating, hypervigilance, exaggerated startle response). The total score was summed and ranged from 17 to 85 |
| ICU memory | Through study completion, an average of seven days | The ICU-Memory Tool (ICU-M) was used to measure ICU patients' ICU experience (Jones et al., 2000). The tool includes 14 questions (five open-ended questions and nine closed-ended questions), mainly including three parts: memories before admission to ICU; memories during ICU stay and memories after transferring out of ICU. Memories during ICU stay has three subscales: factual memories (lights, alarms, voices, families, faces, breathing tube, suctioning, darkness, clock, tube in your mouth, and ward wounds), memories of feelings (being uncomfortable, confused, down, anxious/ frightened, panic, and pain), and memories of delusions (feeling that people were trying to hurt you, hallucinations, nightmares, dreams). We summed the number of memories in each of the three subscales. The Chinese version of ICU-M has a Cronbach α coefficient of 0.823 and a scale-level content validity index of 0.946, which confirms its good reliability and validity |
| Depressive symptoms | Through study completion, an average of seven days | The 9-item Chinese version of Patient Health Questionnaire-9 (PHQ-9) will be used to measure patients' psychological well-being.Patients will be asked for their agreement to the description of each item, from zero (not at all) to three (nearly every day). All item scores are summed (total score = 27). A higher score indicates greater severity of the depressive symptoms. |
| Family satisfaction | Through study completion, an average of seven days | Family satisfaction will be measured using the Critical Care Family Satisfaction Survey (CCFSS).CCFSS has 27 items and five dimensions: medical condition guarantee, access to information, acceptance, support, and comfort. Family caregivers will be asked for their agreement to the description of each item, from one (very unsatisfactory) to five (very satisfactory). All item scores are summed (total score = 135). A higher score indicates a greater level of satisfaction. |
| Level of anxiety | Through study completion, an average of seven days | The level of anxiety of family caregivers will be measured by the Self-Rating Anxiety Scale (SAS). SAS has 20 items, with each item ranging from one (not at all) to four (very much so). The scale will use both positive and negative scoring, with a total score of 50-59 indicating mild anxiety, 60-69 indicating moderate anxiety, and ≥70 indicating severe anxiety. |
Countries
China
Outcome results
None listed