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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-14

Study Completion Date

2025-10-09

Brief Summary

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

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Detailed Description

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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).

Conditions

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Intensive Care Unit Critical Care Sleep Quality Anxiety Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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music combined with lavender essential oil group

nonpharmacological intervention

Group Type EXPERIMENTAL

music combined with lavender essential oil group

Intervention Type DEVICE

listening of 30 mins ocean wave music, aromatherapy of lavender essential oil, and eye masks and earplugs.

routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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music combined with lavender essential oil group

listening of 30 mins ocean wave music, aromatherapy of lavender essential oil, and eye masks and earplugs.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes