Intensive Care UnitSleepNCT06774599
Effects of Nonpharmacological Interventions in Sleep Quality, Anxiety, and Delirium for Patients of Adult Intensive Care Units
A study testing music combined with lavender essential oil group in people with Intensive Care Unit and Critical Care, run by Chiayi Christian Hospital.
Trial summary
This study will investigate the effect of nonpharmacological intervention in sleep quality, anxiety and delirium among adult ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Unit, Critical Care, Sleep Quality
- What is being tested?
- music combined with lavender essential oil group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2025to 9 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Nonpharmacological Interventions in Sleep Quality, Anxiety, and Delirium for Patients of Adult Intensive Care Units: a Randomized Controlled Trial
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).
- Conditions
- Intensive Care Unit, Critical Care, Sleep Quality, Anxiety, Delirium
- Being tested
- music combined with lavender essential oil group
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music combined with lavender essential oil groupDevice
listening of 30 mins ocean wave music, aromatherapy of lavender essential oil, and eye masks and earplugs.
| Study group | Role | What they receive |
|---|---|---|
| music combined with lavender essential oil group | Experimental | nonpharmacological intervention Receives: Device: music combined with lavender essential oil group |
| routine care | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality1
The investigator records the sleep quality using Richards-Campbell sleep scale
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start14 Mar 2025 (estimated)
- Primary completion9 Oct 2025 (estimated)
- Study completion9 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774599
- Sponsor's protocol ID
- 2023079
- Other IDs
- R112-57
- Acronym
- Sleep
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nonpharmacological Interventions in Sleep Quality, Anxiety, and Delirium for Patients of Adult Intensive Care Units: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06774599
- Acronym / sponsor ID
- Sleep / 2023079
- Conditions
- Intensive Care Unit, Critical Care, Sleep Quality, Anxiety, Delirium
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Study start
- 14 Mar 2025 (estimated)
- Primary completion
- 9 Oct 2025 (estimated)
- Study completion
- 9 Oct 2025 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| music combined with lavender essential oil group | Experimental | Device: music combined with lavender essential oil groupnonpharmacological intervention |
| routine care | No intervention | –routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music combined with lavender essential oil grouplistening of 30 mins ocean wave music, aromatherapy of lavender essential oil, and eye masks and earplugs. | Device | music combined with lavender essential oil group |
Primary outcome
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
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing music combined with lavender essential oil group in people with Intensive Care Unit and Critical Care, run by Chiayi Christian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Yin Hou (+886-5-2765041, 05503@cych.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.