Can the Use of Ear Plugs and Eye Masks Help to Improve Sleep Quality After Major Abdominal Surgery?

The importance of good sleep has been gaining interest in critically ill patients as poor sleep is associated with increased rates of delirium, non-invasive ventilation failure and stress to the patient.

The use of earplugs and eye masks has been shown to result in longer sleep time and better sleep quality. The primary outcome of this randomized control trial is to evaluate if the use of eye masks and earplugs in patients undergoing major abdominal surgery will lead to improved sleep quality. Secondary outcomes include the level of noise intensity in the various monitored units, incidence of delirium, nursing demand, length of hospitalization and anaesthetic techniques. With these findings, we hope to be able to improve patients' overall satisfaction with the healthcare received.

Study Overview

• Status: Completed
• Conditions: Sleep; Critical Care; Major Abdominal Surgery
• Intervention / Treatment: Other: Ear plugs and eye masks

Detailed Description

The importance of good sleep has been gaining interest in critically ill patients as poor sleep has been found to be associated with increased rates of delirium, non-invasive ventilation failure, and may serve as a stressor to patients. The use of earplugs and eye masks to improve sleep quality has been described in the critically ill patient population and outcomes have suggested that such interventions have resulted in longer sleep time and Rapid Eye Movement sleep, shorter sleep onset latency and less awakenings, with an enhanced perceived sleep quality. In the post-anaesthesia care unit, these interventions have also led to significantly preserved sleep quality in patients. The primary outcome of this randomized control trial is to evaluate if the use of eye masks and earplugs in patients undergoing major abdominal surgery, and who will be admitted to a monitored unit postoperatively, will lead to improved sleep quality. Secondary outcomes evaluated include the level of noise intensity in the various monitored units (Intensive Care Unit/Intermediate Care Area/High Dependency Ward), incidence of delirium, nursing demand, length of hospitalization and anaesthetic techniques. With these findings, we hope to be able to improve patients' overall satisfaction with the healthcare received.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients who are 21 years old and above, undergoing elective major abdominal surgery in Singapore General Hospital, and who are anticipated to require a monitored bed postoperatively will be identified via Operating Theatre Management system the day before surgery. Postoperatively, these patients must have a Glasgow Coma Scale of at least 10, able to obey verbal commands and stay in a monitored unit postoperatively (Intensive Care Unit/Intermediate Care Area/High Dependency).

Exclusion Criteria:

• Patients who have known hearing impairment, dementia, confusion, delirium or with a tracheostomy will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; Patients will be provided with ear plugs and eye masks, to be used from 10pm to 6am, for 3 days post-operatively.	Other: Ear plugs and eye masks; Patients in the intervention arm will be provided with ear plugs and eye masks and instructed on the use of these during sleep
No Intervention: Control; No ear plugs or eye masks provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of sleep quality between the 2 arms based on Richard Campbell sleep questionnaire	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of overall patient satisfaction between the 2 arms based on Richard Campbell sleep questionnaire		3 days
Frequency of nursing interventions required during the night	Subjective assessment by nurses	3 days
Incidence of delirium, based on twice daily scoring on the Neecham Confusion Tool	Neecham Confusion Tool consists of 9 scoring components: Attention (score of 0-4), Command (score of 0-5), Orientation (0-5), Appearance (0-2), Motor Behaviour (0-4), Verbal Behaviour (0-4), Vital Function Stability (0-2), Oxygen Saturation Stability (0-2) and Urinary Continence Control (0-2). The sum of the scores from each component is combined into a Total Neecham Score, with higher scores indicating that the patient is less likely at risk of delirium.	3 days
Duration of hospitalisation		through study completion, an average of 1 year
Noise intensity in the various monitored care units	Measured using a sound detector, in decibels	3 days

Collaborators and Investigators

• Sponsor: Singapore General Hospital

Publications and helpful links

General Publications

• Leong RW, Davies LJ, Fook-Chong S, Ng SY, Lee YL. Effect of the use of earplugs and eye masks on the quality of sleep after major abdominal surgery: a randomised controlled trial. Anaesthesia. 2021 Nov;76(11):1482-1491. doi: 10.1111/anae.15468. Epub 2021 Apr 21.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018/2288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No