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Effects of Light and Sound Modification on Sleep Quality and Circadian Rhythm in the MICU Patients

Effects of Light and Sound Modification on Sleep Quality and Circadian Rhythm in the Medical Intensive Care Unit Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04129918
Acronym
MICU
Enrollment
112
Registered
2019-10-17
Start date
2020-01-05
Completion date
2020-12-17
Last updated
2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm, Intensive Care Unit, Sleep Quality, Ventilator

Keywords

intensive care unit, sleep quality, circadian rhythm

Brief summary

This study will investigate the effectiveness of light and sound modification in improving sleep qualit , and circadian rhythms in MICU patients with Mechanical Ventilation in Taiwan. Hypothesis: 1. The sleep quality in intervention group is significant improving than usual-care group at Day 1 (after the first intervention), Day 2 (after the second intervention), and Day 3 (after the third intervention). 2. The circadian rhythm in intervention group is significant improving than usual-care group at Day 1 (after the first intervention), Day 2 (after the second intervention), Day 3 (after the third intervention).

Detailed description

The subjects were divided into experimental and control groups. And the improving quality of sleep intervention was provided only in experimental group. In the experimental group,the patients used earplugs and eye masks during nighttime sleep. In the control group, the received routine intensive care.

Interventions

BEHAVIORALlight and sound modification (earplugs and eye masks)

In the experimental group,the patients used earplugs and eye masks during nighttime sleep.

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

The study was conducted on 126 patients with 56 subjects in experimental group and 56 in control group in the MICU. Effect of ear plugs & eye mask on sleep among ICU patients: a randomized control trial The participants were randomly divided into two groups: with ear plugs and eye mask (experimental group) for 3 successive nights and without ear plugs and eye mask (control group). participants were provided a Sequentially numbered opaque sealed envelopes.

Intervention model description

This is a single-center, prospective, randomized control trial in the medical intensive care unit of the Shin Kong Wu Ho-Su Memorial Hospital.

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. ICU stay for 7 days 2. Endotracheal or Tracheostomy patients

Exclusion criteria

1. Patients with ear injury 2. Hearing impairment 3. Eye disease or injuries

Design outcomes

Primary

MeasureTime frameDescription
Subjective sleep qualitybaseline after recruited] using Chinese version of Richards-Campbell Sleep QuestionnaireSubjective sleep quality

Secondary

MeasureTime frameDescription
Objective sleep qualitybaseline, Day 1, Day 2, and Day 3] using ActigraphyObjective sleep quality
Circadian rhythmsbaseline, Day 1, Day 2, and Day 3] using ActigraphyCircadian rhythms including 24-h autocorrelation coefficient (r24), in bed less than out of bed dichotomy index (I\<O) collection, Mesor, Amplitude, and Acrophase from actigraphy

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026