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Not yet recruiting NCT06774599

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

No phase Interventional Intensive Care Unit Critical Care Sleep Quality Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: music combined with lavender essential oil group.
Who it may be relevant to
Registry conditions: Intensive Care Unit, Critical Care, Sleep Quality, Anxiety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Sleep Quality1 [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.]
  • Sleep Quality2 [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.]
  • Anxiety1 [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.]
  • Anxiety2 [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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06774599 · 2023079 · R112-57

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗