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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06774599
• Lead Sponsor: Chiayi Christian Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-01-08
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-12
• Last Update Submitted: 2025-01-12
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Study Start: 2025-03-14
• Primary Completion: 2025-10-09
• Study Completion: 2025-10-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sleep Quality1	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.	The investigator records the sleep quality using Richards-Campbell sleep scale
Sleep Quality2	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.	The investigator records the sleep quality using Verran sleep scale
Anxiety1	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.	The investigator records the degree of anxiety using the spielberger state- trait anxiety inventory
Anxiety2	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.	The investigator records the degree of anxiety using the Visual analogue scale.