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

Effects of Nonpharmacological Interventions in Sleep Quality, Anxiety, and Delirium for Patients of Adult Intensive Care Units: a Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium; Anxiety; Sleep Quality; Critical Care; Intensive Care Unit
• Intervention / Treatment: Device: music combined with lavender essential oil group

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yin Hou; Phone Number: +886-5-2765041; Email: 05503@cych.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: music combined with lavender essential oil group; nonpharmacological intervention	Device: music combined with lavender essential oil group; listening of 30 mins ocean wave music, aromatherapy of lavender essential oil, and eye masks and earplugs.
No Intervention: routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality1	The investigator records the sleep quality using Richards-Campbell sleep scale	To record the sleep quality at 5 times, T1: the time before treatment; T2-T4: the following three days after treatment; T5: the day leaving ICU.
Sleep Quality2	The investigator records the sleep quality using Verran sleep scale	To record the sleep quality at 5 times, T1: the time before treatment; T2-T4: the following three days after treatment; T5: the day leaving ICU.
Anxiety1	The investigator records the degree of anxiety using the spielberger state- trait anxiety inventory	To record the anxiety at 5 times, T1: the time before treatment; T2-T4: the following three days after treatment; T5: the day leaving ICU.
Anxiety2	The investigator records the degree of anxiety using the Visual analogue scale.	To record the anxiety at 5 times, T1: the time before treatment; T2-T4: the following three days after treatment; T5: the day leaving ICU.

Collaborators and Investigators

• Sponsor: Chiayi Christian Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 14, 2025
• Primary Completion (Estimated): October 9, 2025
• Study Completion (Estimated): October 9, 2025

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 12, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Anxiety Disorders
• Other Study ID Numbers: 2023079; R112-57 (Other Grant/Funding Number: Ditmanson Medical Foundation Chia-Yi Christian Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No