Effects of Nonpharmacological Interventions in Sleep Quality, Anxiety, and Delirium for Patients of Adult Intensive Care Units

Chiayi Christian Hospital

Status: Not yet enrolling

Conditions: Critical Care; Delirium; Sleep Quality; Intensive Care Unit; Anxiety

Treatments: Device: music combined with lavender essential oil group

Study type: Interventional

Funder types: Other

Identifiers

NCT06774599

R112-57 (Other Grant/Funding Number)

2023079

Details and patient eligibility

About

This study will investigate the effect of nonpharmacological intervention in sleep quality, anxiety and delirium among adult ICU patients.

Full description

Background: Due to the intensive care unit (ICU) noisy environment, nearly 66% critically ill patientsseem to suffer from poor sleep quality, which can easily lead to complications, such as anxiety, delirium, prolong hospital stay, and even increased mortality.

Objective: This study will investigate the effect of nonpharmacological intervention in sleep quality, anxiety and delirium among adult ICU patients.

Methods: The design of this study is a randomized experimental study recruiting 154 patients from five adult ICUs in a teaching hospital located in the central southern Taiwan. The experimental group (n=77, nonpharmacological intervention, and the control group (n=77, routine care). The nonpharmacological intervention involves listening of 30 mins ocean wave music, aromatherapy of lavender essential oil, and eye masks and earplugs. Research measurement tools, including demographic data, physiological index questionnaire, Richards-Campbell sleep scale (RCSQ), Chinese Visin-style sleep scale, Chinese State -Trait Anxiety Inventory-1, visual analogue scale for anxiety, which will be measured five times, before intervention (T1), every 9AM for three days (T2, T3, T4), and ICU transferring day (T5). SPSS 26.0 will be used to analyze data by using descriptive statistics, chi-square test, pearson correlation, independent t-test, paired t-test, ANOVA, generalized estimating equation (GEE).

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Conscious and able to speak or write (GCS ≥ 11)
• Hemodynamically stable
• Normal hearing and able to communicate in a low voice
• Stay in ICU for more than 24 hours
• Aged over 18 years.

Exclusion criteria

• Pre-existing insomnia diagnosis with long-term reliance on sleep medication,
• Sleep-related medical history such as sleep apnea
• Shift work prior to hospitalization
• Diagnosis of alcohol abuse or schizophrenia
• End-of-life or terminal conditions
• Allergy to essential oils
• Exclusion of dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

music combined with lavender essential oil group

Experimental group

Description:

nonpharmacological intervention

Treatment:

Device: music combined with lavender essential oil group

routine care

No Intervention group

Description:

routine care