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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06774599
Acronym
Sleep
Enrollment
154
Registered
2025-01-14
Start date
2025-03-14
Completion date
2025-10-09
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Critical Care, Delirium, Intensive Care Unit, Sleep Quality

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).

Interventions

DEVICEmusic combined with lavender essential oil group

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

Sponsors

Chiayi Christian Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep Quality1To 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 Quality2To 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
Anxiety1To 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
Anxiety2To 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.

Contacts

Primary ContactYi Yin Hou
05503@cych.org.tw+886-5-2765041

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026