Evaluating the effects of earplug placement intervention on sleep quality in patients in an intensive care unit

Not Applicable

Completed

• Conditions: Sleep disturbance; Nervous System Diseases; Disorders of initiating and maintaining sleep [insomnias]

• Registration Number: ISRCTN29988120
• Lead Sponsor: Hualien Tzu Chi Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-12-31
• Study Start: 2020-01-22
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

1. Aged < 20 years
2. Conscious
3. Able to read and communicate
4. Have a stay in the ICU that was expected to be more than 48?h

Exclusion Criteria

1. Use of sedatives
2. Cognitive or hearing impairment
3. Mechanical ventilation or physical restraints

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Sleep quality measured using the Chinese version of the Richards–Campbell Sleep Questionnaire (RCSQ) at home prior to admission,<br> at Day 1 (baseline), and at Day 2 (after the intervention)<br> 2. Urinary melatonin (MT6s) level measured using liquid chromatography-mass spectrometry (LC-MS; ACQUITY QDa, Waters Corp. MA, USA) at Day 1 (baseline), and at Day 2 between 10 pm and 7 am<br> 3. Vital signs measured using a physiologic monitor (GE CARESCAPE Central Station, MA, USA), continuously measured during the ICU stay. The values of the vital signs were retrieved at 30-min intervals during the intervention night:<br> 3.1. Respiratory rate<br> 3.2. Heart rate<br> 3.3. Mean arterial pressure (MAP)<br>