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

NCT06774599 | Not Yet Recruiting DMC

• 2 other identifiers: 2023079R112-57
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Sleep Quality1

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

  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

  The investigator records the sleep quality using Verran sleep scale

  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

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

  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

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

  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.

Study Arms (2)

music combined with lavender essential oil group

EXPERIMENTAL

nonpharmacological intervention

Device: music combined with lavender essential oil group

routine care

NO INTERVENTION

routine care

Interventions

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.

music combined with lavender essential oil group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiayi Christian Hospital: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Delirium

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Central Study Contacts

Yi Yin Hou

CONTACT

+886-5-2765041; 05503@cych.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 14, 2025
• Study Start: March 14, 2025
• Primary Completion: October 9, 2025
• Study Completion: October 9, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share