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NCT Number: NCT06774599

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

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

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Key information

Conditions

Intensive Care Unit Anxiety Anxiety Disorders Confusion Critical Care Delirium Dyssomnias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

music combined with lavender essential oil group

Device

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

Primary outcomes

  1. 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.

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

  2. 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.

    The investigator records the sleep quality using Verran sleep scale

  3. 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.

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

  4. 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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Yin Hou

CONTACT

[email protected]

+886-5-2765041

Sponsors and collaborators

Lead sponsor

Chiayi Christian Hospital

Other

Registry information

Official study title

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

Acronym: Sleep

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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