Improving Sleep and Reducing External Stimuli With the Maya: a Pilot Study on Experience, Feasibility and Applicability
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Primary Endpoint
- Quality of sleep
Study Overview
Brief Summary
Lack of sleep is a large problem for many patients in hospitals. Common causes are nuisances by light and sound. Especially with critically ill patients in the Intensive Care unit (ICU), Medium Care Unit (MCU) and Cardiac Care Unit (CCU), who are are monitored intensively, a lack of sleep often occurs.
Patients with a lack of sleep more offer suffer from delirium, are more often anxious and stressed, and have a longer length of stay in the hospital. Also, patients' lack of sleep enhances nurses workloads during nightshifts. Because of this, there is a strong need for innovative devices which aim to limit the light and sound nuisances and thereby enhance patients' quality of sleep in the ICU, MC and CCU.
The Maya is a special "cover" which can be placed over the head of the bed. As a result patients are able to limit light and sound nuisances and enhance their privacy.
With this pilot-study we aim to determine:
- The feasibility and experiences of patients and healthcare professionals with the Maya.
- To determine the effect size of dependent variables which can be used in future studies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult ICU, MC or CCU patients with 5 to 7 expected number of admission days
- •patients with an expected Richmond Agitation Sedation Scale (RASS) of >-3 and < +3
- •patients who speak Dutch (because of the qualitative evaluation of the Maya)
Exclusion Criteria
- •patients with severe brain damage
- •patients with a severe psychiatric disorder
Outcomes
Primary Outcomes
Quality of sleep
Time Frame: up to six days
patients' quality of sleep is measured once a day with the Richard Campbell Sleep Questionnaire (RCSQ); (minimum score 0 = worst sleep - maximum score 100 = best sleep)
Secondary Outcomes
- Respiratory rate(up to six days)
- NRS sleep(up to six days)
- Delirium CCU(up to six days)
- Sound(up to six days)
- Hart rate(up to six days)
- Blood pressure(up to six days)
- Arousal(up to six days)
- Anxiety(up to six days)
- NRS Stress(up to six days)
- Delirium ICU/MC(up to seven days)
- Light(up to six days)
- oxygen saturation(up to six days)
Investigators
Bram Tilburgs
Principal Investigator
Radboud University Medical Center