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Not yet recruitingNCT06774599SleepUpdated Jan 14, 2025

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

An interventional study of music combined with lavender essential oil group in Intensive Care Unit, Critical Care and Sleep Quality, sponsored by Chiayi Christian Hospital. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Chiayi Christian Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Intensive Care Unit
  • Critical Care
  • Sleep Quality
  • Anxiety
  • Delirium
03

In context

Sleep Initiation and Maintenance Disorders

2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.

This study's planned enrollment of 154 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Chiayi Christian Hospital is the lead sponsor of 27 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
154 participants (estimated)

Study arms

  • Experimental
    music combined with lavender essential oil group

    nonpharmacological intervention

    Device: music combined with lavender essential oil group

  • No intervention
    routine care

    routine care

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.

06

What researchers measure

Primary outcomes

  1. Sleep Quality1

    The investigator records the sleep quality using Richards-Campbell sleep scale

    Time frame: 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.

  2. Sleep Quality2

    The investigator records the sleep quality using Verran sleep scale

    Time frame: 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.

  3. Anxiety1

    The investigator records the degree of anxiety using the spielberger state- trait anxiety inventory

    Time frame: 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.

  4. Anxiety2

    The investigator records the degree of anxiety using the Visual analogue scale.

    Time frame: 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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06774599
Lead sponsor
Chiayi Christian Hospital
Responsible party
Sponsor
First posted
Jan 14, 2025
Start date
Mar 14, 2025 (estimated)
Primary completion
Oct 9, 2025 (estimated)
Completion
Oct 9, 2025 (estimated)
Last update
Jan 14, 2025

Study contacts

Yi Yin Hou
Contact
05503@cych.org.tw
+886-5-2765041

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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