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

Shin Kong Wu Ho-Su Memorial Hospital

Status: Completed

Conditions: Ventilator; Circadian Rhythm; Sleep Quality; Intensive Care Unit

Treatments: Behavioral: light and sound modification (earplugs and eye masks)

Study type: Interventional

Funder types: Other

Identifiers

NCT04129918

20190804R

Details and patient eligibility

About

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).

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

experimental group

Experimental group

Description:

ear plugs and eye mask for 3 successive nights

Treatment:

Behavioral: light and sound modification (earplugs and eye masks)

control group

No Intervention group

Description:

without ear plugs and eye mask