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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29988120

Enrollment

107

Registered

2020-01-22

Start date

2017-04-04

Completion date

Unknown

Last updated

2020-02-10

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

Conditions

Sleep disturbance Nervous System Diseases Disorders of initiating and maintaining sleep [insomnias]

Interventions

A single-center randomized controlled trial was conducted to evaluate the effectiveness of earplug placement alone on perceived sleep quality, urinary melatonin level, and relaxation responses includi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Sleep quality measured using the Chinese version of the Richards–Campbell Sleep Questionnaire (RCSQ) at home prior to admission, at Day 1 (baseline), and at Day 2 (after the intervention) 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 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: 3.1. Respiratory rate 3.2. Heart rate 3.3. Mean arterial pressure (MAP)	—

Measure

Time frame

1. Sleep quality measured using the Chinese version of the Richards–Campbell Sleep Questionnaire (RCSQ) at home prior to admission, at Day 1 (baseline), and at Day 2 (after the intervention) 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 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: 3.1. Respiratory rate 3.2. Heart rate 3.3. Mean arterial pressure (MAP)

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Countries

Taiwan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026