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NCT Number: NCT04306016

The Effects of a Model-based Sensory Stimulation Intervention on Preventing Delirium Among Intensive Care Unit Patients: A Randomised Controlled Trial

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensory stimulation

Other

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.

Primary outcomes

  1. Delirium incidence

    Time frame: Through study completion, an average of seven days

    Delirium incidence means the number of patients who are delirious.

  2. First occurrence of delirium

    Time frame: 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.

  3. Delirium duration

    Time frame: 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.

  4. Delirium severity

    Time frame: 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 outcomes

  1. Post-traumatic stress disorder (PTSD)

    Time frame: 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

  2. Depressive symptoms

    Time frame: 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.

  3. Family satisfaction

    Time frame: 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.

  4. Level of anxiety

    Time frame: 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.

  5. ICU memory

    Time frame: 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

  6. Depressive symptoms

    Time frame: At one month upon patients' admission to ICU

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 12, 2020
Registry last updated
Apr 6, 2022

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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